[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-acidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-acidosis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,39,70,99,130,165,192,216,247,271,297],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100652978","bicarbonate-hd-study-100652978",false,"NCT07779200","Bicarbonate HD Study","Factors Affecting Bicarbonate Levels In Patients On Haemodialysis","Inclusion Criteria:\n\n* Age 18 years and above.\n* Ability to give informed consent.\n* End Stage Renal Disease established on maintenance dialysis for at least 3 months.\n* Patients on dialysis 3 times a week\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Patients with acute kidney injury\n* Patients with severe COPD","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","The primary goal of this single centre observational study is to look at factors that affect serum bicarbonate levels in patients on maintenance dialysis. This will be done by collecting demographic information, relevant medical history, dialysis history, potential renal acid load from diet by recording different foods consumed over 2 days in a food diary and bicarbonate levels at 3 intervals, pre and post dialysis session 1 and pre dialysis session 2.\n\nBicarbonate levels are of significant interest as an indicator of metabolic acidosis in CKD dialysis patients. This study will allow us to understand the efficacy of different dialysis modalities in controlling bicarbonate levels. It will also enable us to understand the idea of individualizing dialysis for patients in terms of not using a standard concentration of dialysate for all patient undergoing dialysis in this center.",[24,25],"Metabolic Acidosis","CKD on Hemodialysis Patients","RECRUITING","2026-08-20",{"date":29,"type":30},"2026-08-21","ACTUAL",{"date":32,"type":30},"2026-05-12",{"date":34,"type":20},"2026-08",{"name":36,"class":37},"East and North Hertfordshire NHS Trust","OTHER_GOV",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":38},"100625591","phase-4-a-study-of-tris-hydroxymethyl-aminomethane-tham-versus-sodium-bicarbonate-in-cardiac-surgical-patients-100625591","NCT07424625","A Study of Tris-Hydroxymethyl Aminomethane (THAM) Versus Sodium Bicarbonate in Cardiac Surgical Patients","THAM VErsus Sodium BiCarbOnate In CaRdiac SuRgical PatiEnts, A PragmatiC, Comparative-effectiveness Prospective Trial","* Inclusion criteria\n\n  * Cardiothoracic surgery with use of cardiopulmonary bypass\n  * Presence of metabolic acidosis (defined as a base excess of \\\u003C-5)\n  * Minnesota Research Authorization\n* Exclusion criteria\n\n  * Non-cardiac surgery patients or cardiac surgery without cardiopulmonary bypass\n  * Absence of metabolic acidosis (metabolic acidosis being defined as a base excess of \\\u003C-5)\n  * Pregnant patients\n  * Prisoners\n  * Opt out of Minnesota Research Authorization","21 Years",{"count":48,"type":20},250,"INTERVENTIONAL",[51],"PHASE4","The purpose of this research is to determine if two commonly used medications to treat metabolic acidosis in the setting of cardiac surgery, sodium bicarbonate and THAM, are equivalent.",[24],[55,56,57,58],"THAM","Sodium bicarbonate","metabolic acidosis","cardiac surgery","NOT_YET_RECRUITING","2026-07-31",{"date":62,"type":30},"2026-08-03",{"date":64,"type":20},"2026-09",{"date":66,"type":20},"2028-06",{"name":68,"class":69},"Mayo Clinic","OTHER",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":49,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100620241","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-veverimer-for-the-treatment-of-metabolic-acidosis-100620241","NCT07355062","A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Veverimer in Adults With CKD and Metabolic Acidosis","Inclusion Criteria:\n\n* Have provided written informed consent prior to participation in the study.\n* Male or female participants 18 years of age or older.\n* Diagnosed with CKD (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2) and not expected to require renal replacement therapy (dialysis or kidney transplant) throughout the duration of the study.\n* Within 6 months prior to screening have at least two SBC between 12 and 20 mmol\u002FL, inclusive. If only one historical SBC is available, a second SBC may be drawn on screening visit S1 and analyzed by the local laboratory.\n* Within screening period have two central laboratory SBC (at least 24 hours apart and more than 4 hours after food) between 12 and 21 mmol\u002FL, inclusive.\n* Willing to keep food consumption similar to baseline throughout the entire study.\n* If taking oral alkali therapy, dose has been stable for at least 28 days prior to the start of screening and is expected to remain stable throughout the study.\n* Women who are of childbearing potential must have a negative pregnancy test and agree to abstinence or to use contraception.\n\nExclusion Criteria:\n\n* Any participant deemed by the Investigator to be an inappropriate candidate for PerfO testing (e.g., severe musculoskeletal pain, non-ambulatory status), inability to complete STS5 without support or with a screening STS5 time \\\u003C 10 seconds.\n* History or current diagnosis of:\n\n  1. Clinically significant gastroparesis or a history of bariatric surgery.\n  2. Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery including gastrectomy, or known active gastric\u002Fduodenal ulcers.\n  3. Severe recurrent diarrhea or constipation, as assessed by the Investigator.\n  4. Pernicious anemia, atrophic or autoimmune gastritis, achlorhydria or hypochlorhydria.\n* Ineligible per REVIVE GastroScreen test.\n* Use of GI polymer binders or sodium zirconium cyclosilicate within 14 days prior to the start of screening or have an expectation to initiate treatment during the study.\n* Use of acid reducing drugs, including PPIs, H2RAs or P-CABs within 14 days prior to the start of screening or have an expectation to initiate treatment during the study. Very sporadic use (one time per week or less) may be acceptable, as assessed by the Investigator.\n* Initiation of GLP-1 receptor agonists within 6 months prior to the start of screening, or expectation to initiate use during the study. Participants that have been on a GLP-1 receptor agonist for more than 6 months and have maintained a stable dose and steady body weight for at least one month prior to the start of screening may be considered for enrollment, upon Medical Monitor review. GLP-1 receptor agonists also should not be started during the study.\n* Participants that are taking any of the following medications and have not been on a stable dose for at least 14 days prior to the start of screening or have an expectation to change dose during the study: diuretics, non-ophthalmic carbonic anhydrase inhibitors, diabetes drugs, RAAS inhibitors, calcium or magnesium supplements, non-polymer phosphate binders, and SGLT-2 inhibitors. These medications also should not be started during the study.\n* Active, recurrent, or metastatic malignancy at the start of screening.\n* History of malignancy, except under the following conditions:\n\n  1. Carcinoma in situ (e.g., of the cervix, breast, or bladder) that has been completely excised and shows no evidence of residual disease.\n  2. Non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been completely excised and show no evidence of recurrence.\n  3. Low grade prostate cancer, in the opinion of the Investigator (i.e., no metastasis, Gleason score \\\u003C 6), with no significant worsening for \\> 6 months prior to the screening visit.\n  4. Any other malignancy that was treated with curative intent and has been in complete remission for ≥ 5 years prior to the screening visit.\n* Two or more hospitalizations within 12 months prior to the start of screening or a hospitalization within the last 3 months prior to the start of screening due to fluid overload, heart failure, acute kidney injury (AKI) or electrolyte disorders, including hyperkalemia. Participants that have not been hospitalized within the past 3 months and whose condition is stable may be considered for enrollment.\n* Screening hemoglobin \\\u003C 9 g\u002FdL.\n* Low bicarbonate value(s) at time of screening that are due to underlying primary respiratory alkalosis.\n* Investigational medication administration within 28 days prior to start of screening.\n* Participants that are taking an average of \\> 30 units of insulin daily, unless recent (within last 6 months) hemoglobin A1C is \\\u003C 6.5%.\n* History of alcoholism or drug\u002Fchemical abuse within 1 year prior to the start of screening, in the opinion of the Investigator.\n* Current, regular use of inhaled\u002Fingested cannabis\u002FTHC products.\n* Inability to take the IP or otherwise comply with the protocol.\n* Any medical condition, uncontrolled systemic disease or serious concurrent illness that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results, in the opinion of the Investigator.",{"count":78,"type":20},150,[80],"PHASE3","The purpose of this study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.",[83,24],"CKD",[83,24,85,86,87],"Veverimer","STS5","Bicarbonate","2026-07-27",{"date":90,"type":30},"2026-07-28",{"date":92,"type":30},"2026-01-13",{"date":94,"type":20},"2027-06",{"name":96,"class":97},"Renibus Therapeutics, Inc.","INDUSTRY",22,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":49,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":128,"locationsCount":38},"100645632","pilot-trial-of-oral-sodium-bicarbonate-versus-higher-dialysate-bicarbonate-in-hemodialysis-patients-with-metabolic-acidosis-100645632","NCT07688434","Pilot Trial of Oral Sodium Bicarbonate Versus Higher Dialysate Bicarbonate in Hemodialysis Patients With Metabolic Acidosis","Comparative Pilot Trial of Oral Sodium Bicarbonate Versus Increased Dialysate Bicarbonate in Chronic Hemodialysis Patients With Metabolic Acidosis","Bicarbonate-HD","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Chronic hemodialysis for at least 3 months.\n* Stable hemodialysis prescription: 3 times a week, high-flux dialyzers, no major change in dialysis prescription in the previous weeks.\n* Predialysis low \"alkaline reserves\" (serum bicarbonate concentration) according to the operational threshold used in the unit (e.g., \"alkaline reserves\" \\\u003C 22 mmol\u002FL), consistent with KDIGO 2017 definition of metabolic acidosis.\n* Ability to give written informed consent.\n\nFor the observational group:\n\n* Age ≥ 18 years.\n* Chronic hemodialysis for at least 3 months.\n* Hemodialysis 3 times a week, high-flux dialyzers.\n* Predialysis \"alkaline reserves\" considered stable and within the locally defined normal range (≥ 22mmol\u002FL).\n* Ability to give written informed consent.\n\nExclusion Criteria:\n\n* Recent hemodynamic instability (e.g., repeated intradialytic hypotension or unstable blood pressure in the previous weeks).\n* Recent hospitalization for an acute condition.\n* Acute infection or major intercurrent acute event at the time of screening.\n* Major change in dialysis prescription in the 2 weeks prior to inclusion (e.g., change in dialysis schedule, duration, or dialysate composition outside the study protocol).\n* Severe digestive disorders limiting oral intake (e.g., persistent vomiting, severe malabsorption, or any condition preventing safe oral Bicardis administration).\n* Known hypernatremia or high risk of uncontrolled sodium and fluid overload (as judged by the investigator).\n* Severe uncontrolled hypercalcemia or hypocalcemia.\n* Any condition that, in the investigator's judgment, would preclude safe participation or interfere with study procedures (e.g., very limited life expectancy, inability to attend scheduled visits).\n* Refusal to participate or inability to provide written informed consent.",{"count":108,"type":20},37,[110],"NA","Metabolic acidosis is frequent in chronic hemodialysis patients and is associated with adverse clinical outcomes. Two commonly used strategies to correct acidosis are oral sodium bicarbonate supplementation and increasing the bicarbonate concentration of the dialysate, but their comparative effectiveness and tolerance in routine care remain uncertain. This pilot, prospective, randomized, open-label, single-center trial will compare oral sodium bicarbonate versus higher dialysate bicarbonate in chronic hemodialysis patients with metabolic acidosis, using predialysis plasma bicarbonate concentrations, so-called \"reserves alcalines\" or \"alkaline reserves\" in local laboratory reports, as a pragmatic marker of acid-base status.\n\nApproximately 30 acidotic patients (serum bicarbonate \\\u003C 22 mmol\u002FL) will be randomized 1:1 to receive either oral sodium bicarbonate or an increase in dialysate bicarbonate for 6 weeks. An additional non-acidotic observational group will provide descriptive reference data. The primary outcome is the change in predialysis serum bicarbonate from baseline (Day 0) to Day 42 between the two randomized arms. Secondary outcomes include the proportion of patients reaching target serum bicarbonate levels, the weekly kinetics of correction, dialysis adequacy (Kt\u002FV and online clearance monitoring), intradialytic tolerance (blood pressure, cramps, hypotension, symptoms), sodium-related safety (natremia, interdialytic weight gain), and the effects of acidosis correction on nutritional and bone-mineral metabolism, including changes in serum albumin, calcium, phosphorus, and parathyroid hormone (PTH). Feasibility indicators such as recruitment, retention, adherence to treatment and dialysate adjustment, and data completeness will also be described to inform the design of a larger definitive trial.",[113,114,24],"End-stage Renal Disease (ESRD)","Chronic Hemodialysis",[116,117,24,118,119,120,121],"Hemodialysis","End-Stage Renal Disease","Oral sodium Bicarbonate","Dialysate Bicarbonate","Pilot Trial","Bicarbonate Supplementation","2026-07-18",{"date":124,"type":30},"2026-07-21",{"date":126,"type":20},"2026-07",{"date":64,"type":20},{"name":129,"class":69},"University of Sfax",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":49,"phases":141,"briefSummary":143,"conditions":144,"keywords":151,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100438049","phase-2-sodium-bicarbonate-and-mitochondrial-energetics-in-persons-with-ckd-100438049","NCT04984226","Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD","Randomized Cross-over Trial of Sodium Bicarbonate on Muscle Mitochondrial Energetics and Physical Endurance in Chronic Kidney Disease and Metabolic Acidosis","Senergy-CKD","Inclusion Criteria:\n\n* Moderate-severe CKD determined by eGFR \\\u003C50ml\u002Fmin per 1.73m2 by CKD EPI equation on at least 2 consecutive occasions.\n* Metabolic acidosis defined as bicarbonate level\\\u003C24 on two consecutive occasions. Bicarbonate level of 24 or less allowed if eGFR\\\u003C=45ml\u002Fmin per 1.73m2\n* Age 21 to 85 years old\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Poorly controlled diabetes (HgbA1c\\>10%)\n* History of persistent hyperkalemia (K\\>5.4)\n* History of persistent hypokalemia (K\\\u003C3.3)\n* Uncontrolled blood pressure (\\>170\u002F100)\n* Chronic treatment with renal replacement therapy\n* History of aortic dissection or severe valvular heart disease\n* Exercise induced angina\n* Uncontrolled cardiac dysrhythmia\n* Oxygen dependent chronic obstructive pulmonary disease (COPD)\n* Symptomatic claudication\n* End stage liver disease\n* Mobility disability defined as inability to walk without human assistance\n* Dementia or psychosis\n* Patients who cannot consent\n* Active use of intraveneous drugs\n* Non-english speaking\n* History of transplant\n* Implants that prohibit MRI measurements or trauma involving metal fragments\n* Pacemaker\n* Expectation to start dialysis during the course of study.\n* Women who are breastfeeding, pregnant, or are wanting to become pregnant\n* Any condition which in the judgement of the clinical investigator places the participant at risk from participation in the study.\n\nExclusion criteria for optional muscle biopsy\n\n* Drugs- anticoagulants or antiplatelets:\n\n  * Anticoagulants, any 1 (coumadin, rivaroxaban, apixaban, dabigatran, edoxaban)\n  * Antiplatelets, any 2 (aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticragrelor, ticlopidine, vorapaxar)\n* Platelet count \\\u003C100,000\n* International normalized ratio (INR)\\>1.4","85 Years",{"count":140,"type":20},80,[142],"PHASE2","Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.",[145,24,146,147,148,149,150],"Chronic Kidney Diseases","Fatigue","Physical Endurance","Insulin Resistance","Mitochondrial Energetics","Diabetes",[152,153,154],"Metabolic acidosis","Chronic kidney disease","Insulin resistance","2026-05-04",{"date":157,"type":30},"2026-05-06",{"date":159,"type":30},"2023-09-08",{"date":161,"type":20},"2026-12-31",{"name":163,"class":69},"University of California, Davis",2,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":49,"phases":175,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100628652","phase-4-sodium-bicarbonate-for-critically-ill-patients-with-metabolic-acidosis-and-acute-kidney-injury-100628652","NCT07464431","Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury","Evaluating the Clinical Effectiveness of Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury (ESCALATE)","ESCALATE","Inclusion Criteria:\n\n1. Adult ≥ 18 years\n2. Critically ill patients (requiring treatment on an ICU or IMC)\n3. Metabolic acidosis, defined as all of the following:\n\n   1. Arterial pH ≤7.25\n   2. PaCO2 \\\u003C 6.5kPa (\\\u003C49 mmHg)\n   3. Standard bicarbonate ≤20 mmol\u002FL\n   4. Standard Base Excess \\\u003C-2\n4. AKI stage 2 or 3 of the KDIGO classification\n5. Written informed consent of the patient or legal representative or authorized representative or emergency inclusion (according to Article 35 EU-Regulation 536\u002F2014)\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding patients\n2. Respiratory acidosis (acute or chronic) \\[dynamic, and if corrected, patient may be reconsidered for the trial\\]\n3. Patients on KRT, or KRT immediately indicated and treating clinician(s) unwilling to defer\n4. Deemed unsuitable for KRT\n5. High output stoma\u002Fileostomy\n6. Percutaneous biliary drainage\n7. End stage kidney failure defined as documented eGFR \\\u003C15ml\u002Fmin\u002F1.73m 2 prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysis\n8. Known renal tubular acidosis\n9. Diabetic ketoacidosis\n10. High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)\n11. Symptomatic hypocalcaemia (Ionized calcium \\\u003C1.05 mmol\u002FL)\\[dynamic, and if corrected, patient may be reconsidered for the trial\\]\n12. Hypernatremia (plasma sodium \\>150 mmol\u002FL)\\[dynamic, and if corrected, patient may be reconsidered for the trial\\]\n13. Severe hypokalemia (potassium \\\u003C3.0 mmol\u002FL)\\[dynamic, and if corrected, patient may be reconsidered for the trial\\]\n14. Death perceived as imminent\n15. Known hypersensitivity to sodium bicarbonate or EDTA (Disodiumedetate)\n16. Previously randomized into ESCALATE",{"count":174,"type":20},660,[51],"The study investigates whether sodium bicarbonate is able to reduce the occurrence of major adverse kidney events on day 90 (MAKE90) in critically ill patients with metabolic acidosis and acute kidney injury (AKI). While its efficacy in this context has been suggested in a subgroup analysis of the BICAR-ICU trial it has not been confirmed in a double-blinded randomized controlled trial to date.",[178,24,179],"Acute Kidney Injury","Critical Illness",[181,152,182,56],"Acute kidney injury","Critical illness","2026-04-28",{"date":185,"type":30},"2026-05-05",{"date":187,"type":20},"2026-05",{"date":189,"type":20},"2028-12",{"name":191,"class":69},"Universität Münster",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":199,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100583846","a-study-on-bedside-formate-assay-as-a-diagnostic-tool-in-methanol-poisoning-100583846","NCT06881641","A Study on Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning","Sensitivity, Specificity, and Acceptability of a Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning: Prospective Observational and Randomized Studies","Inclusion Criteria:\n\n• Patients presenting with suspected methanol poisoning or metabolic acidosis of unknown cause, including:\n\n* Children aged 16-17 years, who are willing to provide assent.\n* Parents\u002FGuardians of children who are able and willing to provide consent.\n* Adults (aged 18 years with no upper age limit) who are willing to provide informed consent.\n* Participants who lack capacity to consent for themselves but who have a relative who is willing and able to provide informed consent on behalf of the participant.\n\nSuspected methanol poisoning will be based on clinician judgement using the following typical indicators of possible methanol ingestion:\n\n1. History of:\n\n   * Intake of illegal\u002Fbootleg\u002Fspurious alcohol, and\u002For\n   * Other patients admitted with confirmed\u002Fsuspected methanol poisoning and\u002For\n   * Time from intake to symptoms \\>6-12 h\n2. Symptoms\u002Fclinical findings\n\n   * Coma, and\u002For\n   * Hyperventilation (respiratory rate \\[RR\\] \\>20\u002Fmin) and\u002For dyspnea, and\u002For\n   * Visual disturbances (blurred vision, blindness), and\u002For\n   * Gastrointestinal symptoms (vomiting, abdominal pain), and\u002For\n   * Chest pain, and\u002For\n   * Severe\u002Funusual 'hang-over': Feeling very sick the following day, and\u002For\n   * Pseudopapillitis\n\nMetabolic acidosis of unknown origin will be based on the following features:\n\n* Metabolic acidosis of unknown origin = origin not identified. The acidosis is not of unknown origin if the metabolic acidosis can be explained by another cause eg. lactic acidosis (e.g. where base deficit \\[BD\\] = 15 mM \\[i.e., base excess (BE) = -15 mM\\] and lactate is 12-15mM).\n* An initial ABG shall be drawn. If the BD is \\>15mM (BE\\\u003C-15mM), the patient shall be included (as long as \"unknown origin\" - see above). If the patient has a BD between 5-15, the acidosis is only moderate, and there is time to do the \"fluid trial\" (see below). If the acidosis improves within 1-2 hours after the fluid trial, the acidosis is unlikely to be because of methanol and the patient should not be included. If the acidosis does not improve, the patient should be included.\n\nExclusion Criteria:\n\n* • Children aged 16-17 years, who are unwilling to provide assent.\n\n  * Parents\u002FGuardians of children who are unable or unwilling to provide consent.\n  * Adults (aged 18 years with no upper age limit) who are unwilling to provide informed consent.\n  * Participants who lack capacity to consent for themselves and who do not have a relative who is willing and able to provide informed consent on behalf of the participant (i.e. unaccompanied unconscious patients and others)\n  * Individuals previously recruited to the study.","16 Years",{"count":201,"type":20},6120,"Methanol poisoning is a serious issue, particularly in low- and middle-income countries (LMICs), where outbreaks can devastate communities. Diagnosing methanol poisoning is challenging because its symptoms mimic many other conditions, and traditional diagnostic methods require expensive lab equipment. Unfortunately, this often means doctors do not even consider methanol poisoning as a diagnosis. Methanol itself isn't highly toxic, but when the body breaks it down into formate, it becomes dangerous, leading to brain swelling and even death.\n\nTo address this, a study team has developed a new method to diagnose methanol poisoning using a single drop of blood with a device that can be used at the bedside, eliminating the need for any lab equipment. This point-of-care (POC) test measures formate, which is only present in cases of methanol poisoning.\n\nThe project consists of two sequential studies. The first study aims to compare the effectiveness of the POC formate test against standard lab tests, which can take several hours. The findings from this study will inform the second study.\n\nThe second study is a feasibility cluster randomized controlled trial. In this trial, entire hospitals, rather than individual patients, are randomly assigned different approaches, similar to tossing a coin. The goal is to determine whether this trial design can be used in larger-scale research to evaluate clinical outcomes. Specifically, it will examine whether the POC formate test can accelerate accurate diagnosis, enabling prompt treatment and preventing deaths.",[24],[205],"methanol toxicity","2026-03-27",{"date":208,"type":30},"2026-03-30",{"date":210,"type":30},"2025-06-22",{"date":212,"type":20},"2028-02-28",{"name":214,"class":69},"University of Edinburgh",6,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":49,"phases":226,"briefSummary":228,"conditions":229,"keywords":233,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":38},"100544234","phase-1-adding-urea-to-the-final-dialysis-fluid-100544234","NCT06366230","Adding Urea to the Final Dialysis Fluid","Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities","Urea dialysate","Inclusion Criteria:\n\n* Serum Urea \\> 120\n* Serum Potassium \\> 5.5 or serum CO2 \\\u003C 15 or need for aggressive dialysis due to toxic ingestion\n* need for dialysis\n\nExclusion Criteria:\n\n* Pediatric\n* need for CRRT",{"count":225,"type":20},20,[227,142],"PHASE1","At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and\u002For fix the metabolic acidosis.",[230,231,232,24],"Dysequilibrium Syndrome","ESRD","Hyperkalemia",[231,234,235,236,237],"Urea","Disequilibrium","Potassium","Acid\u002Fbase","2026-02-09",{"date":240,"type":30},"2026-02-12",{"date":242,"type":30},"2025-09-16",{"date":244,"type":20},"2028-06-30",{"name":246,"class":69},"University of California, San Francisco",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":49,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":38},"100439707","phase-4-effect-of-alkali-therapy-on-vascular-and-graft-function-in-kidney-transplant-recipients-100439707","NCT05005793","Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients","Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant","Inclusion Criteria:\n\n* Age 18-80 years\n* Serum bicarbonate 16-24 mEq\u002FL on 2 separate measurements (at least 1 day apart)\n* Kidney transplant received 1 year prior to randomization\n* eGFR ≥ 45 ml\u002Fmin\u002F1.73m2 by CKD-EPI equation\n* Blood pressure \\\u003C130\u002F80 mm Hg prior to randomization\n* BMI \\\u003C 40 kg\u002Fm2 (FMD measurements can be inaccurate in severely obese patients).\n* Able to provide consent\n* Immunosuppression regimen consisting of tacrolimus, mycophenolate mofetil and prednisone (95% of patients at University of Colorado are on this regimen)\n* Stable immunosuppression regimen for at least three months prior to randomization\n* Stable anti-hypertensive regimen for at least one month prior to randomization\n* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).\n\nExclusion Criteria:\n\n* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year\n* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)\n* Uncontrolled hypertension\n* Serum potassium \\\u003C 3.3 or ≥ 5.5 mEq\u002FL at screening\n* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months\n* Nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria)\n* Factors judged to limit adherence to interventions\n* Current participation in another research study\n* Pregnancy or planning to become pregnant or currently breastfeeding\n* Chronic use of supplemental oxygen\n* Use of anticoagulants","80 Years",{"count":256,"type":20},120,[51],"Lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also result in improved vascular and graft function. The investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 KTRs to examine the effect of sodium bicarbonate therapy on surrogate markers of CVD and graft function. The overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in KTRs by decreasing complement activation.",[24,260,261],"Kidney Transplant; Complications","Vascular Diseases","2025-05-28",{"date":264,"type":30},"2025-05-29",{"date":266,"type":30},"2021-12-01",{"date":268,"type":20},"2026-08-31",{"name":270,"class":69},"University of Colorado, Denver",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":49,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":38},"100587719","plado-for-conservative-management-of-ckd-100587719","NCT06932042","PLADO for Conservative Management of CKD","Plant Dominant Low-protein Diet for Conservative Management of Chronic Kidney Disease: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18 years and above, having controlled glycemic and blood pressure parameters on treatment, with an established diagnosis of stages 3-5 CKD and an estimated GFR ≤59 ml\u002Fmin\u002F1.73 m2 stable for at least three months, and with a normal nutritional status as defined by the GLIM criteria, attending the CKD outpatient clinics at LAUMC-RH, willing to undergo the baseline screening and attend the monthly face-to-face visits at the outpatient department at LAUMC-RH.\n\nExclusion Criteria:\n\n* Patients with overt infection, persistent anorexia, vomiting, or diarrhea within the last month, presence of wasting diseases such as cancer, tuberculosis, liver failure, heart failure, and those with serum potassium \\>5.5 mEq\u002FL during the past 6 months.",{"count":279,"type":20},48,[110],"The goal of this clinical trial is to learn if a plant-dominant low protein diet, referred to as PLADO diet, works to decrease metabolic acidosis, a major risk factor for chronic kidney disease (CKD) progression, in adults with CKD. It will also learn about the safety, viability, and economic attractiveness of this diet.\n\nThe main questions it aims to answer are:\n\n* Is the PLADO diet more effective in managing metabolic acidosis in comparison with the standard-of-care CKD diet in adults with CKD?\n* Is the PLADO diet safe, viable, and economically attractive adults with CKD?\n\nResearchers will compare the PLADO diet to the standard-of-care CKD diet to see if the PLADO diet works better to decrease metabolic acidosis.\n\nParticipants will:\n\n* Receive nutrition education of the PLADO diet or the standard-of-care CKD diet via monthly sessions for 6 months.\n* Visit the clinic monthly for 6 months, then after 3 months for checkups and tests.",[283,24],"Chronic Kidney Disease(CKD)",[153,57,285,286,287],"PLADO","Plant-dominant low protein diet","Nutrition education","2025-04-09",{"date":290,"type":30},"2025-04-17",{"date":292,"type":30},"2024-05-28",{"date":294,"type":20},"2026-06-30",{"name":296,"class":69},"Lebanese American University",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":305,"sex":16,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":49,"phases":310,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":38},"100558011","phase-3-prevention-of-metabolic-acidosis-in-preterm-neonates-by-replacing-sodium-chloride-with-sodium-acetate-in-parenteral-nutrition-100558011","NCT06545565","Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition","Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition - A Randomized Controlled Trial. (PROTECT Trial)","PROTECT","Inclusion Criteria:\n\n1. Written informed consent obtained by parents\u002Flegal representative (according to local regulations) before the initiation of PN.\n2. All the neonates who were admitted to the NICU of AKUH and received PN during 28 days of their life.\n3. Gestational age \\\u003C 33 weeks\n\nExclusion Criteria:\n\n1. Infants with an inborn error of metabolism\n2. Genetic or congenital condition that affects neurodevelopment or requires multiple surgeries (e.g., congenital viral infection, hydrops, complex congenital heart disease, severe dysmorphic features, etc.)\n3. Severe metabolic alkalosis, in critically ill neonates, is defined as a persistent elevation of the serum pH above 7.45 and it also involves a primary increase in serum bicarbonate (HCO3-) concentration \\> 25mEq\u002FL.\n4. Severe Hypernatremia, in critically ill neonates, is defined as persistently high serum sodium levels \\> 150 mmol\u002FL\n5. Severe liver failure and syndromic infants with multiple congenital abnormalities and severe perinatal asphyxia\n\n   \\-",true,"1 Day","3 Days",{"count":309,"type":20},200,[80],"The goal of this clinical trial is to learn if the addition of sodium acetate in neonatal PN works to prevent and treat metabolic acidosis and associated comorbidities in preterm neonates. It will also teach about the optimal doses of sodium acetate in PN. The main questions it aims to answer are:\n\nIs the incidence of metabolic acidosis reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? Is the rate of neonatal comorbidities reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? What are the optimal neonatal dosing recommendations\u002Fguidelines of sodium acetate in daily PN, which are required to prevent\u002Ftreat metabolic acidosis in the early life of preterm neonates? Researchers will compare Sodium acetate in PN therapy to sodium chloride in PN to see if Sodium acetate works to prevent and treat metabolic acidosis and associated comorbidities.\n\nIncluded Participants:\n\nAll the neonates were admitted to the NICU of AKUH and received PN during 28 days of their lives.\n\nParticipants will receive sodium acetate or sodium chloride Written informed consent was obtained by parents\u002Flegal representatives (according to local regulations) before the initiation of PN. Gestational age \\\u003C 33 weeks Included in the study before 72 hours of life",[24,313,314],"Neonatal Disease","Neonatal Complication",[57,316,317,318],"sodium acetate","neonates","Parenteral Nutrition","2024-08-07",{"date":321,"type":30},"2024-08-09",{"date":323,"type":30},"2024-07-10",{"date":325,"type":20},"2025-05-10",{"name":327,"class":69},"Aga Khan University Hospital, Pakistan"]