Critical Illness Clinical Trial
Official title:
Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial
The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) 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/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.
The REPLENISH is a multicentric, international, open label, randomized controlled trial which will enroll subjects in intensive care unit. Patients will be randomized on day 4 of ICU admission. Until ICU day 4, protein requirement will be provided according to the local practice as long as no intravenous amino acids are given and the average protein intake in the first 4 days does not exceed 0.8 g/kg/day. On ICU day 4, patients will be randomized to one of the two treatment groups: one with standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula and another group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day. Randomization will be stratified by suspected COVID-19 and then by site and the use of renal replacement therapy at the time of randomization (intermittent hemodialysis or continuous renal replacement therapy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
| Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
| Completed |
NCT03671447 -
Enhanced Recovery After Intensive Care (ERIC)
|
N/A | |
| Recruiting |
NCT03941002 -
Continuous Evaluation of Diaphragm Function
|
N/A | |
| Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
| Completed |
NCT04239209 -
Effect of Intensivist Communication on Surrogate Prognosis Interpretation
|
N/A | |
| Completed |
NCT05531305 -
Longitudinal Changes in Muscle Mass After Intensive Care
|
N/A | |
| Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
| Completed |
NCT02916004 -
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
|
N/A | |
| Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
| Completed |
NCT04479254 -
The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)
|
N/A | |
| Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
| Not yet recruiting |
NCT04516395 -
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae
|
N/A | |
| Withdrawn |
NCT04043091 -
Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction
|
N/A | |
| Recruiting |
NCT02922998 -
CD64 and Antibiotics in Human Sepsis
|
N/A | |
| Recruiting |
NCT02989051 -
Fluid Restriction Keeps Children Dry
|
Phase 2/Phase 3 | |
| Completed |
NCT03048487 -
Protein Consumption in Critically Ill Patients
|
||
| Completed |
NCT02899208 -
Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?
|
N/A | |
| Recruiting |
NCT02163109 -
Oxygen Consumption in Critical Illness
|
||
| Completed |
NCT03099746 -
Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE)
|
N/A |