Replacing Protein Via Enteral Nutrition in Critically Ill Patients

Conditions

Critical Illness, Nutrition Disorders

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.

Sophie Zaloumis, Matthew J. Summers, Jeffrey Presneill, Rinaldo Bellomo, Lee‐anne S. Chapple et al. (19 authors)

Trials2025-02-064 citations

10.1186/s13063-025-08759-0

Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial

Yaseen M. Arabi, Hasan M. Al‐Dorzi, Omar Aldibaasi, Musharaf Sadat, Jesna Jose et al. (100 authors)

Trials2024-05-023 citations

10.1186/s13063-024-08105-w

Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: the REPLENISH randomized clinical trial protocol.

Arabi YM, Al-Dorzi HM, Sadat M, Muharib D, Algethamy H, Al-Hameed F, Mady A, AlGhamdi A, Almekhlafi GA, Al-Fares AA, Kharaba A, Al Bshabshe A, Maghrabi K, Al Ghamdi K, Rasool G, Chalabi J, AlHumedi HI, Sakkijha MH, Alamrey NK, Alhutail RH, Sifaoui K, Almaani M, Alqahtani R, Qureshi AS, Hejazi MM, Arishi H, AlQahtani S, Ghazi AM, Baaziz ST, Azhar AO, Alabbas SF, AlAqeely M, AlOrabi O, Al-Mutawa A, AlOtaibi M, Aldibaasi O, Jose J, Starkopf J, Preiser JC, Perner A, Al-Dawood A, Saudi Critical Care Trials Group.

2023-07-306 citations

10.1186/s13063-023-07507-6

Interventions

OTHERReplenish protein group

For patients with Body mass index(BMI) \<30, 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

OTHERStandard protein group

For patients with BMI \<30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI \>=30, use adjusted body weight

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

(on ICU calendar day 4 or the morning of day 5) 1. Age ≥18-years old 2. Patient started on enteral nutrition (EN) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes. 3. The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.

Exclusion criteria

1. 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. 2. 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. 3. Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days. 4. Patients being fed entirely through oral route - i.e. those who are eating. 5. Pregnancy. 6. Burn patients. 7. Prisoners or those undergoing forced treatment. 8. Patients with hepatic encephalopathy or Child C liver cirrhosis 9. Inherited defect of amino acid metabolism. 10. Allergies to protein supplement

Design outcomes

Primary

Measure	Time frame	Description
90 day-all cause mortality	90 days	Mortality 90 days post randomization

Secondary

Measure	Time frame	Description
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
Bacteremia until 2 days of ICU stay	until 2 days post ICU.	Any symptoms of bacteremia
New or progression of Skin Pressure Ulcers	ICU stay	anytime during ICU stay
Functional assessment at day 90	Day 90	SARC-F screen for sarcopenia and EuroQoL

Other

Measure	Time frame	Description
Safety outcomes during ICU stay	ICU stay	New episode of stage 2 or higher AKI by KDIGO criteria; 2. Pneumonia defined as episodes of newly confirmed pneumonia according to the modified CDC criteria; 3. Grade IV Acute Gastrointestinal injury (AGI)
Minor safety outcomes during ICU stay	ICU stay	Feeding tolerance; Diarrhoea; Refeeding syndrome

Countries

Saudi Arabia

Contacts

Primary ContactYaseen M Arabi, MD

arabi@ngha.med.sa0118011111

Backup ContactMusharaf Sadat, MBBS

sadatmu@ngha.med.sa0118011111

Outcome results

None listed