Replacing Protein Via Enteral Nutrition in Critically Ill Patients
- Conditions
- Critical IllnessNutrition Disorders
- Interventions
- Other: Standard protein groupOther: Replenish protein group
- Registration Number
- NCT04475666
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2502
Not provided
- 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.
- 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.
- Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
- Patients being fed entirely through oral route - i.e. those who are eating.
- Pregnancy.
- Burn patients.
- Prisoners or those undergoing forced treatment.
- Patients with hepatic encephalopathy or Child C liver cirrhosis
- Inherited defect of amino acid metabolism.
- Allergies to protein supplement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard protein group Standard protein group The subjects randomized to this group will receive standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula. No supplemental protein will be allowed Replenish protein group Replenish protein group The subjects randomized to this 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
- Primary Outcome Measures
Name Time Method 90 day-all cause mortality 90 days Mortality 90 days post randomization
- Secondary Outcome Measures
Name Time Method Functional assessment at day 90 Day 90 SARC-F screen for sarcopenia and EuroQoL
Bacteremia until 2 days of ICU stay until 2 days post ICU. Any symptoms of bacteremia
Days alive at day 90 without life support 90 days use of vasopressor/inotropic support, invasive mechanical ventilation and/or renal replacement therapy
Days alive and out of hospital at day 90 90 days 90 day survival after randomization
New or progression of Skin Pressure Ulcers ICU stay anytime during ICU stay
Trial Locations
- Locations (2)
King Abdulaziz Medical city
🇸🇦Jeddah, Saudi Arabia
Intensive Care Unit, King Abdulaziz Medical City
🇸🇦Riyadh,, Saudi Arabia