Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: the REPLENISH randomized clinical trial protocol
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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.
| Original language | English |
|---|---|
| Article number | 485 |
| Journal | Trials |
| Volume | 24 |
| Issue number | 1 |
| Number of pages | 13 |
| ISSN | 1745-6215 |
| DOIs | |
| Publication status | Published - 2023 |
Bibliographical note
Funding Information:
We would like to thank the Data Safety Monitoring Board chair and members: Michelle Ng Gong, M.D , M.S. (chair) Professor of Medicine. Professor of Epidemiology and Population Health. Albert Einstein College of Medicine. Chief, Department of Medicine Division of Critical Care. Chief, Department of Medicine Division of Pulmonary Medicine. Director, Department of Medicine Critical Care Research. Montefiore Medical Center, Bronx, NY, United States of America. Manpreet Singh Mundi, MD (member) Professor, Department of Medicine, Division of Endocrinology, Diabetes, Metabolism, and Nutrition. Mayo Clinic, Rochester, MN. United States of America. Christopher John Lindsell (member) Professor of Biostatistics and Biomedical Informatics. Director, Vanderbilt Institute for Clinical and Translational Research (VICTR) Methods Program. Co-director, Vanderbilt Health Data Science (HEADS) Center. Nashville Tennessee. United States of America. Collaborators The Saudi Critical Care Trials Group Amal Almatroud, Brintha Naidu, Vicki Burrow, Salha Al Zayer, Haseena Banu Khan, Afonso Varela, Mohamed Ali Alodat, Rayan Alshayeh, AbdulRehman AlHarthi, Naif Al Qahtani, Yasmeen Ayed AlHejiely, Mada Muzhir AlZahrani, Mohammed Haddad Lhmdi, Katrina Baguisa, Huda Mhawisg, Liyakat Khan, Moataz Gabr, Shehla Nuzhat, Madiha ElGhannam, Beverly Bcuizon, Bander AlAnezi, Christine Joy Anaud, Sawsan Albalawi, Manar Alahmadi, Mohammed AlHumaid, Samar Talal Nouri, Rozeena Huma, Khawla Farhan, Samahar Alamoudi, Milyn L Ansing, Raghad Malabari, Kholoud Shobragi, Shaymaa Asaas, Ahmed Quadri, Khalid Idrees, Arwa AlHusseini, Shahinaz Bashir, Mohamed Hussein, Olfa Baji, Abdulrehman Alerw, Khloud Johani, Monera AlEnezi, Ismail Boudrar, Rabiah Atiq, Maali Junid, Maram Yusef, Mona Bin Mabkoot, Munir AlDammad, Yahia Otaif, Osama Hakami, Mariam Ehab Kenawy, Dalal Ali Alkhamees, Tasneem Abdullah Behbehani.
Funding Information:
The study is funded by King Abdullah International Medical Research Center, Ministry of National Guard Health Affairs MNGHA, Mail Code: 1515 PO Box 22490 Riyadh 11426, Kingdom of Saudi Arabia (Grant no:RC19/414/R). The study sponsor has provided support for research coordination, statistical support, and monitoring but does not have any role in the study design, collection, management, and interpretation of the data or preparation, review, or approval of the manuscript or decision to submit the manuscript for publication.
Publisher Copyright:
© 2023, The Author(s).
- Critical illness, Functional outcomes, Mortality, Protein intake, Randomized controlled trial
Research areas
ID: 397382733