[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399015":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":78,"collaborators":23,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":23,"enrollmentInfo":91,"targetDuration":23,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":23,"overallStatus":45,"whyStopped":23,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"King Abdullah International Medical Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Replenish protein group","ACTIVE_COMPARATOR","The subjects randomized to this group will receive the standard amount of proteins (maximum 1.2 g\u002Fkg\u002Fday) from the primary polymeric formula AND supplemental protein at 1.2 g\u002Fkg\u002Fday",[13],"Other: Replenish protein group",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard protein group","The subjects randomized to this group will receive standard prescription without supplemental proteins (maximum1.2 g\u002Fkg\u002Fday) from the primary polymeric formula. No supplemental protein will be allowed",[18],"Other: Standard protein group",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"For patients with Body mass index(BMI) \\\u003C30, use pre-ICU actual body weight(BW) for the calculation; if unavailable, use weight on ICU admission. For patients with BMI \\>=30, use adjusted body weight",[9],null,{"type":6,"name":15,"description":25,"armGroupLabels":26,"otherNames":23},"For patients with BMI \\\u003C30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI \\>=30, use adjusted body weight",[15],[28],{"name":29,"affiliation":30,"role":31},"Yaseen M Arabi, MD","King Saud Bin Abdulaziz University for Health Sciences","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","0118011111","18855","arabi@ngha.med.sa",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Musharaf Sadat, MBBS","10822","sadatmu@ngha.med.sa",[43,69],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"King Abdulaziz Medical city","RECRUITING","Jeddah","21423","Saudi Arabia","SA",{"type":51,"coordinates":52},"Point",[53,54],39.18624,21.49012,{"lat":54,"lon":53},[57,62,67],{"name":58,"role":34,"phone":59,"phoneExt":60,"email":61},"Fahad M Al-Hameed, MD","00966 12 2266666","22771","HameedF@ngha.med.sa",{"name":63,"role":34,"phone":64,"phoneExt":65,"email":66},"Ohoud Al Orabi, MMedSC","0096612 2266666","28864","alorabioh@NGHA.MED.SA",{"name":68,"role":31,"phone":23,"phoneExt":23,"email":23},"Fahad Al-Hameed, MD",{"facility":70,"status":45,"city":71,"state":23,"zip":72,"country":48,"countryCode":49,"cosmosGeoPoint":73,"geoPoint":77,"contacts":23},"Intensive Care Unit, King Abdulaziz Medical City","Riyadh","11426",{"type":51,"coordinates":74},[75,76],46.72185,24.68773,{"lat":76,"lon":75},{"type":79,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100399015","replacing-protein-via-enteral-nutrition-in-critically-ill-patients-100399015",false,"NCT04475666","Replacing Protein Via Enteral Nutrition in Critically Ill Patients","Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial","REPLENISH","Inclusion Criteria(on ICU calendar day 4 or the morning of day 5)\n\n1. Age ≥18-years old\n2. Patient started on enteral nutrition (EN) via nasogastric\u002Forogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes.\n3. The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.\n\nExclusion Criteria:\n\n1. Lack of commitment to full life support or brain death. Patients with \"Do Not Resuscitate\" order but with commitment to ongoing life support can be enrolled.\n2. Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.\n3. Patients who received an average protein of more than 0.8g\u002Fkg\u002Fday in the first 4 ICU days.\n4. Patients being fed entirely through oral route - i.e. those who are eating.\n5. Pregnancy.\n6. Burn patients.\n7. Prisoners or those undergoing forced treatment.\n8. Patients with hepatic encephalopathy or Child C liver cirrhosis\n9. Inherited defect of amino acid metabolism.\n10. Allergies to protein supplement",true,"ALL","18 Years",{"count":92,"type":93},2502,"ESTIMATED","INTERVENTIONAL",[96],"NA","The investigator will investigate the effect of supplemental enteral protein (1.2 g\u002Fkg\u002Fday) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g\u002Fkg\u002Fday) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g\u002Fkg\u002Fday), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.",[99,100],"Critical Illness","Nutrition Disorders","2025-08-31",{"date":103,"type":104},"2025-09-08","ACTUAL",{"date":106,"type":104},"2020-09-21",{"date":108,"type":93},"2026-04-30",{"name":5,"class":6},2]