[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638798":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":62,"studyPopulation":62,"armGroups":70,"interventions":83,"overallOfficials":62,"centralContacts":90,"locations":98,"responsibleParty":116,"collaborators":62,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":62,"enrollmentInfo":130,"targetDuration":62,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":62,"overallStatus":101,"whyStopped":62,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Chulalongkorn University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Change in RF-CSA ultrasonography","Change in RF-CSA, as measured by ultrasonography at day 7","At day 7 after randomization",[14,18,21,24,27,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Numbers of RRT-free days at day 28","Renal replacement therapy-free days (censored at 28 days) is defined as days without RRT at least 3 consecutive calendar days within 28 days after study enrollment","At day 28 after randomization",{"measure":19,"description":20,"timeFrame":17},"Numbers of MV-free days at day 28","Mechanical ventilator-free days (censored at 28 days) is defined as days free from mechanical ventilation within 28 days after study enrollment. A value of 0 is also allocated if the patient died between inclusion and day 28 or still receiving invasive mechanical ventilation at day 28.",{"measure":22,"description":23,"timeFrame":12},"Change in muscle mass by BIA","measured by bioimpedance analysis at day 7",{"measure":25,"description":26,"timeFrame":17},"ICU length of stay","the total number of days a patient spends in ICU",{"measure":28,"description":29,"timeFrame":17},"Hospital length of stay","The total number of days a patient spends in hospital from their admission date to their discharge date",{"measure":31,"description":32,"timeFrame":33},"Daily changes in urea levels","Trend serum urea nitrogen (SUN) in mg\u002FdL in 7 days after randomization","From randomization to the end of treatment at 7 days",{"measure":35,"description":36,"timeFrame":37},"Incidence of gastrointestinal intolerance","Gastrointestinal intolerance is defined as gastrointestinal events reported by primary physicians or patients within treatment period as follows: Vomiting, Diarrhea, Abdominal distension.","through study completion, an average of 1 month",{"measure":39,"description":40,"timeFrame":41},"CPAx","Chelsea Critical Care Physical Assessment (CPAx) 10-item bedside assessment designed to measure physical function and recovery in critically ill ICU patients","At Randomization and At the end of treatment 7 days",[43,47,50,53,55],{"measure":44,"description":45,"timeFrame":46},"Mortality at 28 days and 90 days","Mortality at 90 days","28 days and 90 days after randomization",{"measure":48,"description":48,"timeFrame":49},"Fluid balance at 24 hours, 72 hours and 7 Days","24 hours, 72 hours and 7 Days after Randomization",{"measure":51,"description":51,"timeFrame":52},"Incidence of any arrhythmia","7 days after randomization",{"measure":54,"description":54,"timeFrame":52},"Incidence of catheter related bloodstream infection",{"measure":56,"description":57,"timeFrame":58},"Dialysis depence at Day 28 and Day 90","Dialysis depence at Day 28 and Day 90\n\nRenal recovery is defined in two different ways:\n\n1. Spontaneous urine output more than 500 per day or 2000 mL per day with diuretics AND did not require RRT within 7 days\n2. Spontaneous decrease of serum creatinine value at least 0.3 mg\u002FdL on 2 sets of bloodwork seperated by \\> 24 hours AND did not require RRT within 7 days","28 Days and 90 Days after randomization",{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":62,"timePerspective":62,"maskingInfo":64},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":65,"maskingDescription":66,"whoMasked":67},"DOUBLE","Rectus femoris ultrasonography was performed twice on day 1 and day 7 after randomization by one expert musculoskeletal radiologist blinded to clinical information\n\nBoth feeds are isocaloric and isovolemic and identical in terms of color, odor and consistency",[68,69],"PARTICIPANT","OUTCOMES_ASSESSOR",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"High protein group","EXPERIMENTAL","Patients will receive enteral nutrition via feeding tube. The nutrition provided is a medical nutrition formula with a protein proportion of 7.5 g\u002F100 kcal with caloric content 1.2 kcal\u002Fml. Deliverd protein 1.5-1.7 g\u002Fkg\u002Fd.",[76],"Other: High protein group",{"label":78,"type":79,"description":80,"interventionNames":81},"Standard protein group","ACTIVE_COMPARATOR","Patients will receive enteral nutrition via feeding tube. The nutrition provided is a medical nutrition formula with a protein proportion of 5 g\u002F100 kcal with caloric content 1.2 kcal\u002Fml. Delivered protein 1.0-1.2 g\u002Fkg\u002Fd.",[82],"Other: Standard protein group",[84,87],{"type":6,"name":72,"description":85,"armGroupLabels":86,"otherNames":62},"Patients will receive enteral nutrition via feeding tube. The nutrition provided is a medical nutrition formula with a protein proportion of 7.5 g\u002F100 kcal with caloric content 1.2 kcal\u002Fml.",[72],{"type":6,"name":78,"description":88,"armGroupLabels":89,"otherNames":62},"Patients will receive enteral nutrition via feeding tube. The nutrition provided is a medical nutrition formula with a protein proportion of 5 g\u002F100 kcal with caloric content 1.2 kcal\u002Fml",[78],[91,96],{"name":92,"role":93,"phone":94,"phoneExt":62,"email":95},"Wiphat Kittiweerawong, MD","CONTACT","+66899496165","inter.wiphat@gmail.com",{"name":97,"role":93,"phone":62,"phoneExt":62,"email":62},"Nuttha Lumlertgul, MD, PhD",[99],{"facility":100,"status":101,"city":102,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"King chula memorial hospital","RECRUITING","Bangkok","10330","Thailand","TH",{"type":107,"coordinates":108},"Point",[109,110],100.50144,13.75398,{"lat":110,"lon":109},[113,115],{"name":92,"role":93,"phone":114,"phoneExt":62,"email":95},"0899496165",{"name":97,"role":93,"phone":62,"phoneExt":62,"email":62},{"type":117,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"PRINCIPAL_INVESTIGATOR","Nuttha Lumlertgul, MD","Principal investigator","100638798","effect-of-high-versus-standard-protein-intake-in-critically-ill-patients-with-acute-kidney-injury-requiring-continuous-renal-replacement-therapy-100638798",false,"NCT07596043","Effect of High Versus Standard Protein Intake in Critically Ill Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy","Effect of High Versus Standard Protein Intake in Critically Ill Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy: A Randomized Controlled Trial (PROTEIN-CRRT)","PROTEIN-CRRT","Inclusion Criteria:\n\n* Adult (≥18 years old)\n* AKI receiving CRRT within 7 days after ICU admission\n* Achieve and tolerate calories 70% of target daily caloric requirement (20 kcal \u002Fkg\u002Fd) within 7 days after ICU admission by enteral feeding\n* Participant or their surrogates is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Moribund or withholding of treatment\n* Kidney transplant recipient\n* Previously diagnosed end-stage kidney disease (ESKD) currently on kidney replacement therapy\n* Pregnancy or breastfeeding\n* Hepatic encephalopathy (West Haven grade 3-4)\n* Burn patients\n* Patients whom the responsible clinician felt that the patient either needed low or high protein\n* Severe complications of diabetes such as ketoacidosis, hyperosmolar coma\n* Had pre-existing neuromuscular disorders\n* Previously leg amputations","ALL","18 Years",{"count":131,"type":132},56,"ESTIMATED","INTERVENTIONAL",[135],"NA","During critical illness, patients experience a hypercatabolic state. This hypercatabolic state causes muscle wasting in patients, resulting in intensive care unit acquired weakness (ICU-AW). ICU-AW is associated with prolonged mechanical ventilation (MV) weaning, extubating failure and extended length of stay. Previously recognized risk factors for ICU-AW include shock, sepsis, multiple organ failure, hyperglycemia, and prolonged exposure to corticosteroids, sedatives, or paralytic agents.\n\nCritical illness is complicated by the development of acute kidney injury (AKI). AKI causes muscle wasting by increasing protein degradation and decreasing protein synthesis. Furthermore, patients with severe AKI often require renal replacement therapy (RRT), which contributes to additional protein loss. Studies have estimated that amino acid losses associated with RRT may range from 5 to 19 g\u002Fd, with greater losses observed in patients undergoing continuous renal replacement therapy (CRRT). AKI requiring CRRT has recently been proposed to contribute to an increased risk of ICU-AW.\n\nTherefore, critically ill patients with AKI may require increased protein intake to compensate for these metabolic alterations. However, higher protein intake, particularly during the early acute phase of critical illness, may be associated with prolonged need for RRT or delayed kidney recovery.\n\nThe objective of this trial is to compare the effects of a high protein intake versus a standard protein intake on muscle mass change in critically ill patients with AKI requiring CRRT.\n\nThe goal of this clinical trial is to learn if high protein intake (1.5-1.7 g\u002Fkg\u002Fd) can reduce ICU associated weakness in critically ill patients with AKI requiring CRRT. The main questions it aims to answer is:\n\n• Does High protein intake (1.5-1.7 g\u002Fkg\u002Fd) reduce the change in RF-CSA, as measured by ultrasonography at day 7 in critically ill patients with AKI requiring CRRT Researchers will compare drug high protein intake to standard protein intake to see if high protein intake effect on muscle mass by ultrasonography.\n\nParticipants will:\n\n* Receive high protein group (1.5-1.7 g\u002Fkg\u002Fd) in High protein group and standard protein intake (1.0-1.2 g\u002Fkg\u002Fd) in control group for 7 days\n* Rectus femoris ultrasonography was performed twice on day 1 and day 7",[138,139],"Acute Kidney Failure Stage 3","Continuous Renal Replacement Therapy (CRRT)","2026-10-05",{"date":142,"type":143},"2026-10-07","ACTUAL",{"date":145,"type":143},"2026-09-27",{"date":147,"type":132},"2027-06-30",{"name":5,"class":6},1]