[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Bolivia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":269},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,37,67,92,127,151,178,206,236],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100475978","an-observational-pregnancy-safety-study-in-women-who-were-exposed-to-the-drug-nifurtimox-during-pregnancy-to-learn-about-the-risk-of-pregnancy-complications-and-about-the-mothers-and-babys-health-100475978",false,"NCT05477953","An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health","Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant","Inclusion Criteria:\n\n* Females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period \u002F time of conception to pregnancy outcome).\n* Written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent\u002Flegal guardian).\n\nExclusion Criteria:\n\n* None","FEMALE",{"count":18,"type":19},50,"ESTIMATED","OBSERVATIONAL","This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.\n\nChagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems.\n\nNifurtimox has been used for more than 50 years to treat Chagas disease in children and adults.\n\nIt is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans.\n\nIn this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information:\n\n* Birth defects (abnormal and problematic structures or functions, a child is born with)\n* Pregnancy outcomes (like live birth, preterm birth, still birth\u002Fdeath of the unborn baby, miscarriage, or abortion)\n* Certain health problems of the child up to 12 months of age\n* Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population.\n\nThe study will run for approximately 10 years.",[23],"Chagas Disease","NOT_YET_RECRUITING","2026-07-02",{"date":27,"type":28},"2026-07-06","ACTUAL",{"date":30,"type":19},"2026-12-31",{"date":32,"type":19},"2032-01-31",{"name":34,"class":35},"Bayer","INDUSTRY",12,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100607839","altitude-and-outcomes-in-pediatric-ards-a-multicenter-study-100607839","NCT07193771","Altitude and Outcomes in Pediatric ARDS: A Multicenter Study","Evaluation of Altitude as an Independent Risk Factor for Mortality in Pediatric Acute Respiratory Distress Syndrome: Influence of Oxygenation, Ventilation, and Hospital Structure in a Multicenter Observational Study.","LARed-ALT","Inclusion Criteria:\n\n* Age between 1 month (corrected gestational age) and 18 years.\n* Admission to a pediatric intensive care unit (PICU) or facility where mechanically ventilated children are cared for.\n* Requirement of invasive mechanical ventilation.\n* Diagnosis of pediatric acute respiratory distress syndrome (PARDS) according to PALICC criteria, confirmed within 24 hours before or after endotracheal intubation.\n\nExclusion Criteria:\n\n* Patients with active perinatal lung disease (e.g., neonatal respiratory distress syndrome, pulmonary hemorrhage, persistent pulmonary hypertension of the newborn, early bronchopulmonary dysplasia, meconium aspiration).\n* Patients who have received extracorporeal membrane oxygenation (ECMO) prior to or within the first 24 hours of PARDS diagnosis.\n* Patients with pre-established limitation of therapeutic effort (LTE) orders or palliative care directives documented before the initiation of invasive mechanical ventilation.\n* Readmissions to the PICU during the study period (only the first episode per patient will be included).","ALL","1 Month","18 Years",{"count":49,"type":19},1600,"This multicenter observational study will evaluate the association between geographic altitude, availability of critical care resources, and clinical outcomes in children with pediatric acute respiratory distress syndrome (PARDS). Data on demographics, physiology, and hospital structure will be collected from PICUs located at different altitudes worldwide. The study aims to identify gaps in PARDS management and provide recommendations adapted to diverse resource settings.",[52,53,54],"Respiratory Distress Syndrome, Pediatric","Altitude Hypoxia","High Altitude Effects","RECRUITING","2026-05-29",{"date":58,"type":28},"2026-06-02",{"date":60,"type":28},"2025-11-01",{"date":62,"type":19},"2028-03",{"name":64,"class":65},"Latin American Pediatric Collaborative Network","OTHER",20,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":16,"minAge":47,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100616946","a-prospective-longitudinal-observational-cohort-study-of-pregnant-women-residing-at-high-altitude-in-bolivia-100616946","NCT07312227","A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia","Inclusion Criteria:\n\n* women delivering at participating hospitals at more than 3500 meters or women delivering at participating hospitals at sea level\n* signed informed consent\n\nExclusion Criteria:\n\n* preexisting cardiopulmonary pathologies (CHD, COPD, CKD, NYHA \\> III)",true,"45 Years",{"count":76,"type":19},27,"In this study, the investigators will follow two small cohorts of pregnant women: a cohort of healthy women with uncomplicated pregnancies residing at high altitude, a control group of healthy women with uncomplicated pregnancies residing at sea level, to characterize differences in cardiopulmonary adaptation and nitric oxide (NO) pathway expression at elevations \\>3,500 m throughout pregnancy and into the postpartum period. The investigators aim to investigate right-sided cardiac impairment induced by chronic hypobaric hypoxemia, its effects on fetal growth, and the potential contribution of cardiovascular nitric oxide depletion to obstetric complications.",[79,80,81],"Hypertensive Disorder of Pregnancy","Pulmonary Arterial Hypertension","Intrauterine Growth Restriction","2026-05-21",{"date":84,"type":28},"2026-05-26",{"date":86,"type":28},"2026-02-11",{"date":88,"type":19},"2027-02",{"name":90,"class":65},"Massachusetts General Hospital",2,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":45,"minAge":47,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":101,"conditions":102,"keywords":109,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100613110","epidemiology-and-processes-of-care-for-renal-replacement-therapy-in-acute-kidney-injury-in-latin-america-100613110","NCT07262320","Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America","LATAM-AKID","Inclusion Criteria:\n\n* Adult patient (≥18) admitted to the ICU\n* First ICU admission during current hospitalization\n* Diagnosis of acute kidney injury stage 3 according to KDIGO guidelines\n* RRT initiated no earlier than 3 days before or no later than 7 days after ICU admission\n\nExclusion Criteria:\n\n* Transfer from outside hospital with ongoing RRT\n* RRT exposure of less than 2 days (if CRRT or PD was provided) or less than 2 HD\u002FSLED sessions\n* Kidney failure (ESRD) patients on maintenance dialysis\n* Kidney transplant recipients\n* Previous or new diagnosis of glomerulonephritis",{"count":100,"type":19},1000,"This is an international, multicenter, observational study aimed at investigating acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The main questions this study aims to answer are:\n\n* What is the epidemiology, outcomes, and processes of care for patients with AKI-RRT in Latin America?\n* How do outcomes differ across different countries in Latin America?\n* What factors (demographics, clinical, socioeconomic) influence outcomes in patients with AKI-RRT in Latin America?\n\nThe main aims of this study are to:\n\n* Establish a comprehensive database containing clinical, laboratory, treatment, process, and outcome data of patients with AKI-RRT in Latin America\n* Describe current epidemiology of AKI-RRT in Latin America\n* Compare processes of care and outcomes across different countries in Latin America\n* Provide data resources to facilitate and promote clinical research in AKI-RRT",[103,104,105,106,107,108],"Dialysis","Critically Ill Acute Kidney Injury","Renal Replacement Therapy for Acute Kidney Injury in ICU","Acute Kidney Injury","Renal Replacement Therapy","AKI",[108,110,111,112,113,114,115,116],"ICU","RRT","Latin America","acute kidney injury","renal replacement therapy","intensive care unit","dialysis","2026-03-11",{"date":119,"type":28},"2026-03-12",{"date":121,"type":28},"2026-03-01",{"date":123,"type":19},"2027-06-30",{"name":125,"class":65},"University of Alabama at Birmingham",15,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":45,"minAge":47,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100530894","eulat-eradicate-gbc-100530894","NCT06192719","EULAT Eradicate GBC","Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC","EULAT","Inclusion Criteria:\n\n1. Cohort A. Patients with gallbladder cancer or dysplasia, both before and after the start of their anticancer treatment.\n\n   Cohort B. Patients with cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)\n2. Diagnosis confirmed in accordance with standard protocols of the participating hospitals\n3. Men and women aged 18 or over\n\nExclusion Criteria:\n\n1. Any medical condition that present an unreasonable risk to the participant.\n2. Any psychiatric condition that interferes with understanding informed consent.",{"count":136,"type":19},15000,"Gallstones are relatively frequent in women and constitute one of the main risk factors for gallbladder cancer (GBC).\n\nCurrently, GBC diagnosis is mainly based on imaging (ultrasound or abdominal CT) associated with invasive examinations (biopsy and surgery), with no marker available to date to accurately predict risk and diagnose the disease early. The only curative treatment for GBC remains surgery with complete resection of tumors in early stages.\n\nGiven the aggressiveness of GBC and the very limited therapeutic options, as well as the possibility of preventing GBC by cholecystectomy during the 10 to 20 years required for the development of gallbladder tumors, it is imperative to develop effective and efficient prevention strategies based on a prioritization of interventions according to environmental and genetic-molecular risk factors.\n\nThe investigators aim to identify epidemiological factors linked to the development of GBC, and to identify, validate and functionally characterize genetic-molecular markers in blood, saliva, urine, bile and stool that allow risk prediction, early diagnosis and precision treatment of incidental tumors.",[139,140],"Gallbladder Cancer","Gallstone Disease","2026-02-16",{"date":143,"type":28},"2026-02-18",{"date":145,"type":28},"2019-12-01",{"date":147,"type":19},"2028-12-31",{"name":149,"class":65},"Centre Paul Strauss",36,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":45,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":157,"studyType":20,"phases":4,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100524832","diagnostic-innovations-for-pediatric-tuberculosis-in-bolivia-100524832","NCT06113861","Diagnostic Innovations for Pediatric Tuberculosis in Bolivia","Inclusion Criteria:\n\n* Children presenting for evaluation for symptomatic respiratory disease and suspicion of tuberculosis will be eligible for enrollment (inclusion criteria based on Bolivian Ministry of Health guidelines for suspect cases of tuberculosis in children\n\nExclusion Criteria:\n\n* prior treatment for TB within the past year,\n* current treatment for prevention of TB,\n* weight \\\u003C 2.5 kg., or\n* clinical instability,\n* positive COVID-19 diagnostic test","2 Months","14 Years",{"count":160,"type":19},1220,"Pediatric tuberculosis (TB) continues to pose diagnostic challenges in low- and middle-income countries with high rates of TB disease, due to the well-described impact of paucibacillary disease in children, and current TB culture and polymerase-chain reaction tests are of limited usefulness due to cost, restricted availability, and poor sensitivity in specimens available from younger children. Our team of experts from Tulane, Johns Hopkins University, Universidad Peruana Cayetano Heredia, and Asociación Benéfica Prisma have confronted all of these challenges through more than 25 years of collaboration in Peru and Bolivia. Our goal is to directly address the challenges of TB in children by evaluating a new diagnostic approach developed by MPI Tony Hu at Tulane University using a CRISPR-mediated TB assay (CRISPR-TB) optimized to detect circulating Mycobacterium tuberculosis cell-free DNA (Mtb-cfDNA), and used to analyze cryopreserved serum in pilot studies from adults and children with presumptive TB, their asymptomatic household contacts, and a cohort of symptomatic children living with HIV (CLHIV) at high risk for TB. Results from symptomatic adult cohorts yielded a pooled sensitivity of 93%; specificity of 93%; positive predictive value of 95%; and negative predictive value of 92%. In limited pilot studies in CLHIV CRISPR-TBD results accurately identified all confirmed TB (13\u002F13) and most children with unconfirmed TB (80%; 52\u002F65). We propose to enroll 200 presumptive TB cases and an equal number of well control subjects in each of 2 study populations (test population and validation population) identified through clinics associated with the \"Dr. Mario Ortiz Suarez\" Children's Hospital in Santa Cruz, Bolivia. We will determine the distribution of cfDNA concentrations in peripheral blood in a \"test population\" composed of two age-based groups of children (2 months-6 years, 7-14 years) with respiratory disease grouped by likelihood of TB based on the NIH consensus case definitions (confirmed TB, unconfirmed TB, and unlikely TB) and in age-matched controls grouped by presence of latent TB infection (LTBI), with cfDNA measured serially in time among TB cases receiving antibiotic therapy. We will also validate standard ranges of quantitative cfDNA established for clinical subgroups of children with TB disease or LTBI in an independent validation cohort. An additional aim will determine the correlation between quantitative cfDNA and quantitative imaging-based TB scores based on evidence of disease in the lung, the primary target organ in TB disease, by (1) chest radiograph, measured by computer-aided analysis using the CAD4TB v7 system, and by (2) lung ultrasound, performed with a portable\u002Flow-cost probe assisted by machine learning algorithms for automatic interpretation. These biomarkers will be tested as potential cofactors that may be combined with cfDNA levels in peripheral blood, to improve the detection of TB disease in children. The results of this study will be the first step in a process to find a path to allow detection of the many \"unconfirmed\" TB cases and ideally make the diagnosis of pediatric TB in reach for low resource settings where it is so critically needed.",[163],"Tuberculosis",[165,166,167],"Diagnostic testing","Children","Imaging analysis","2025-09-03",{"date":170,"type":28},"2025-09-05",{"date":172,"type":28},"2024-04-15",{"date":174,"type":19},"2028-10",{"name":176,"class":65},"Tulane University",1,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":45,"minAge":46,"maxAge":186,"enrollmentInfo":187,"targetDuration":189,"studyType":20,"phases":4,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":91},"100571129","relationship-of-nutritional-support-for-critically-ill-children-with-clinical-outcomes-in-a-pediatric-hospital-in-bolivia-nutpebol-100571129","NCT06716229","Relationship of Nutritional Support for Critically Ill Children With Clinical Outcomes in a Pediatric Hospital in Bolivia (NutPeBol)","Relationship of Nutritional Support for Critically Ill Children With Clinical Outcomes in a Pediatric Hospital in Bolivia in 2025 (NutPeBol)","NutPeBol","Inclusion Criteria:\n\n* Admitted to intensive care or intermediate care in hospital wards\n* Complete clinical and anthropometric data.\n\nExclusion Criteria:\n\n* Congenital or acquired chronic disease affecting growth (secondary malnutrition)\n* On medication (corticosteroids, immunoglobulins, albumin)\n* Burn patients, with prosthetic implants, postoperative of large tumor resections.\n* Unknown history of pre-referral hospital management or hospitalized in other health facilities.","15 Years",{"count":188,"type":19},56,"4 Weeks","The aim of this observational study is to learn about the characteristics of nutritional support in critically ill children. The primary question to be answered is Is there an association between nutritional support of the critically ill child and clinical and hospital outcomes in children admitted to a pediatric referral center? Patients will be followed throughout their hospitalization, with a step-by-step evaluation of the nutritional support received through standard care and a review of the results obtained in the patients.",[192,193],"Critically Ill Children","Nutritional Support",[195,196],"Critically Ill children","Nutritional support","2025-03-11",{"date":199,"type":28},"2025-03-14",{"date":201,"type":19},"2025-04-06",{"date":203,"type":19},"2025-12-19",{"name":205,"class":65},"MPH D Raul Copana-Olmos",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":45,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":177},"100558399","phase-2-treatment-of-bolivian-l-braziliensis-mucosal-leishmaniasis-with-inhaled-pentamidine-plus-oral-miltefosine-100558399","NCT06550609","Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine","Inclusion Criteria:\n\n* Gender: Male or female\n* Age: \\>12 yrs of age\n* Weight: \\> 45 kg\n* Consent: Prior to any investigations\n* Mucosal disease: Involvement of the nares, nasal mucosa, palate, pharynx, larynx according to the ENT specialist.\n* Parasitology: Parasitological confirmation of the lesion (s) will be made by visualization of Leishmania, culture of Leishmania, or molecular identification of Leishmania (PCR) from the biopsy or aspirate of the lesion (s); or a positive Leishmanin skin test plus a scar characteristic of cutaneous leishmaniasis, plus the epidemiologic antecedent of living now or in the past, in an endemic area.\n\nExclusion Criteria:\n\n* Previous treatment for leishmaniasis: No specific or putatively specific therapy (Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol) in the last 12 months. Patients may have been previously treated with the agents under investigation---miltefosine, pentamidine---if that treatment ended more than 12 months ago and the disease has not diminished in the last 6 months.\n* Other diseases: Concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.\n* Laboratory : Values of complete blood count, liver function (AST, ALT, alkaline phosphatase), renal function (creatinine, BUN), pancreatic function (lipase), or uric acid beyond 1.5 x Normal Range and that in the PI's opinion would be clinically meaningful.\n* EKG: Clinically significant abnormalities.\n* Contraception: Women of childbearing age are required to practice reproductive contraception for 5 months after initiating therapy: abstinence or effective contraception defined as 2 forms of contraception \\[a barrier method (diaphragm, condom, or cervical cap with spermicidal foam, gel, or cream) plus a 2nd barrier method or hormonal contraceptive or intrauterine device\\] from day 1 through 5 months post therapy.","12 Years",{"count":214,"type":19},30,"INTERVENTIONAL",[217],"PHASE2","This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis.",[220],"Mucosal Leishmaniasis",[222,223,224,225,226],"Leishmaniasis","Mucosal leishmaniasis","Miltefosine","Pentamidine","Combined therapy","2025-02-24",{"date":229,"type":28},"2025-02-26",{"date":231,"type":28},"2025-02-04",{"date":233,"type":19},"2028-02",{"name":235,"class":65},"Fundacion Nacional de Dermatologia",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":45,"minAge":244,"maxAge":47,"enrollmentInfo":245,"targetDuration":4,"studyType":215,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":268},"100552877","phase-2-early-resuscitation-in-paediatric-sepsis-using-inotropes-100552877","NCT06478797","Early Resuscitation in Paediatric Sepsis Using Inotropes","Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)","ANDES-CHILD","Inclusion Criteria:\n\n* 28 days and \\\u003C18 years\n* Treated for sepsis\n* Received at least 20 ml\u002Fkg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock\n* Parental\u002Fcaregiver consent prior to or after enrolment\n\nExclusion Criteria:\n\n* Preterm babies born \\\u003C34 weeks gestation that have a corrected age of \\\u003C28 days\n* Received ≥ 40 mL\u002Fkg of fluid boluses during the 4 h pre-enrolment\n* Inotrope infusion commenced pre-enrolment\n* Lack of access (intraosseous, central venous or peripheral) to administer fluids and\u002For inotropes after 60min of enrolment\n* Cardiomyopathy or chronic cardiac failure\n* Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment\n* Known chronic renal failure (defined as requiring renal replacement therapy)\n* Known chronic hepatic failure\n* Palliative care patient\u002Fpatient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation)\n* Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of \\>2min duration, or death is deemed to be imminent or inevitable during this admission.\n* Major bleeding with haemorrhagic shock\n* Sepsis is not likely to be the cause of shock\n* Previous enrollment in ANDES-CHILD","28 Days",{"count":246,"type":19},40,[217],"Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL\u002Fkg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)",[250],"Sepsis",[252,253,254,255,256,257,258],"pediatric sepsis","septic shock","inotropes","adrenaline","emergency department","fluid","child","2024-06-24",{"date":261,"type":28},"2024-06-27",{"date":263,"type":19},"2024-07",{"date":265,"type":19},"2025-12",{"name":267,"class":65},"NATALIA LOPERA MUNERA",4,""]