Journal Article

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

Sadat, Musharaf, Algethamy, Haifa, Alabbas, Sara Fahad, Almekhlafi, Ghaleb. A., Arishi, Hatim, Preiser, Jean-Charles, Maghrabi, Khalid, Ghazi, Amro Mohamed, Starkopf, Joel, Al-Hameed, Fahad, AlOrabi, Ohoud, Azhar, Abeer Othman, Chalabi, Jamal, Sakkijha, Maram Hasan, Jose, Jesna, Aldibaasi, Omar, Al-Fares, Abdulrahman A., AlGhamdi, Adnan, Al-Dawood, Abdulaziz, AlQahtani, Samah, Al Bshabshe, Ali, Alqahtani, Rakan, AlAqeely, Mohammed, Hejazi, Mohammed Moneer, Almaani, Mohammed, AlOtaibi, Maha, Muharib, Dina, Mady, Ahmed, Rasool, Ghulam, Alamrey, Norah Khalid, Kharaba, Ayman, Al-Mutawa, Aliaa, Alhutail, Rabeah Hamad, Perner, Anders, Qureshi, Ahmad S., Sifaoui, Kaouthar, Al Ghamdi, Khalid, Al-Dorzi, Hasan M., Arabi, Yaseen M., AlHumedi, Haifaa Ibrahim, Baaziz, Saleh T.

2023

Overview

Background Protein intake is recommended in critically ill patients to mitigate the negative effects of critical illness-induced catabolism and muscle wasting. However, the optimal dose of enteral protein remains unknown. We hypothesize that supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition formula to achieve high amount of enteral protein (range 2–2.4 g/kg/day) given from ICU day 5 until ICU discharge or ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8–1.2 g/kg/day) would reduce all-cause 90-day mortality in adult critically ill mechanically ventilated patients. Methods The REPLENISH (Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial is an open-label, multicenter randomized clinical trial. Patients will be randomized to the supplemental protein group or the control group. Patients in both groups will receive the primary enteral formula as per the treating team, which includes a maximum protein 1.2 g/kg/day. The supplemental protein group will receive, in addition, supplemental protein at 1.2 g/kg/day starting the fifth ICU day. The control group will receive the primary formula without supplemental protein. The primary outcome is 90-day all-cause mortality. Other outcomes include functional and quality of life assessments at 90 days. The trial will enroll 2502 patients. Discussion The study has been initiated in September 2021. Interim analysis is planned at one third and two thirds of the target sample size. The study is expected to be completed by the end of 2025. Trial registration ClinicalTrials.gov Identifier: NCT04475666 . Registered on July 17, 2020.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Amino acids / Biomedicine / Body mass index / Brain death / Calories / Clinical medicine / Clinical practice guidelines / Clinical trials / Comparative analysis / Consent / Critical illness / Critical Illness - therapy / Critically ill / Energy / Enrollments / Enteral feeding / Enteral nutrition / Enteral Nutrition - adverse effects / Enteral Nutrition - methods / Food and nutrition / Functional outcomes / Health aspects / Health Sciences / Hospital patients / Humans / Illnesses / Intensive Care Units / Liver cirrhosis / Medicine / Medicine & Public Health / Metabolism / Mortality / Multicenter Studies as Topic / Nutrition / Nutritional aspects / Ostomy / Parenteral nutrition / Patients / Protein intake / Proteins / Proteins in human nutrition / Quality of Life / Randomized controlled trial / Randomized Controlled Trials as Topic / Sample Size / Statistics for Life Sciences / Study Protocol / Time / Tube feeding / Ventilation / Ventilators