biostudies-literatureArabi YMKing Abdullah International Medical Research CenterNovo Nordisk Fonden296https://www.ebi.ac.uk/biostudies/studies/S-EPMC11064302biostudies-literatureUnknown25(1)<h4>Background</h4>The optimal amount and timing of protein intake in critically ill patients are unknown. REPLENISH (Replacing Protein via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial evaluates whether supplemental enteral protein added to standard enteral nutrition to achieve a high amount of enteral protein given from ICU day five until ICU discharge or ICU day 90 as compared to no supplemental enteral protein to achieve a moderate amount of enteral protein would reduce all-cause 90-day mortality in adult critically ill mechanically ventilated patients.<h4>Methods</h4>In this multicenter randomized trial, critically ill patients will be randomized to receive supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition to achieve a high amTrialsStatistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial.PMC11064302NNF19OC0054863Kharaba AKhan HBMaghrabi KAlbalawi SPreiser JCAlshahrani MSand the Saudi Critical Care Trials GroupJunid MAnsing MLAlGhamdi KAlqahtani RAlodat MAAl Zayer SAlerw AAlGhamdi AAl-Dawood ABcuizon BAlBakhiet NAlamoudi SAlghethamy HAlabbas SFAlbrahim TShobragi KAl-Dorzi HMNouri STAlmaani MAlEnezi MAzhar AOBaguisa KMuharib DHejazi MMAlfilfil WAAlHumaid MAl-Fares AAChalabi JAtiq RGhazi AMHussein MAlfilfil WAMAnaud CJAlmekhlafi GAAl-Hameed FAlMubarak JHAlQahtani SBashir SStarkopf JAlHumedi HIIdrees KLhmdi MHJose JSakkijha MHAl Qahtani NHefni LElghannam MFAsaas SSadat MMhawisg HQureshi ASNuzhat SAlmatroud AArabi YMOtaif YAlaskar ASAsonto LPBaji OJohani KAldibaasi OAlOrabi OAlHusseini AAlHejiely YABaaziz STAlOtaibi MSifaoui KAl Bshabshe AVarela AAlshayeh RMady AArishi HBuabbas SFAlamrey NKRasool GBoudrar INaidu BHakami OQuadri AAlkraidees AFAlAnezi BMalabari RFarhan KBurrow VAlAqeely MGabr MAlZahrani MMAlahmadi MBin Mabkoot MPerner AAlDammad MAl-Mutawa AHazem WMYusef MHuma RKhan LAlgethamy HAlHarthi AAlhutail RHfalseStatistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial.<h4>Background</h4>The optimal amount and timing of protein intake in critically ill patients are unknown. REPLENISH (Replacing Protein via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial evaluates whether supplemental enteral protein added to standard enteral nutrition to achieve a high amount of enteral protein given from ICU day five until ICU discharge or ICU day 90 as compared to no supplemental enteral protein to achieve a moderate amount of enteral protein would reduce all-cause 90-day mortality in adult critically ill mechanically ventilated patients.<h4>Methods</h4>In this multicenter randomized trial, critically ill patients will be randomized to receive supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition to achieve a high am2024-01-01T00:00:00Z2024 May2026-06-02T08:37:07.02Z2026-05-26T03:07:03.31ZS-EPMC110643023869844210.1186/s13063-024-08105-w