Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial.
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Arabi Yaseen M, Al-Dorzi Hasan M, Aldibaasi Omar, Sadat Musharaf, Jose Jesna, Muharib Dina, Algethamy Haifa, Al-Fares Abdulrahman A, Al-Hameed Fahad, Mady Ahmed, Kharaba Ayman, Al Bshabshe Ali, Maghrabi Khalid, AlGhamdi Khalid, Rasool Ghulam, AlGhamdi Adnan, Almekhlafi Ghaleb A, Chalabi Jamal, AlHumedi Haifaa Ibrahim, Sakkijha Maram Hasan, Alamrey Norah Khalid, Alaskar Amjad Sami, Alhutail Rabeah Hamad, Sifaoui Kaouthar, Alqahtani Rakan, Qureshi Ahmad S, Hejazi Mohammed Moneer, Arishi Hatim, AlQahtani Samah, Ghazi Amro Mohamed, Baaziz Saleh T, Azhar Abeer Othman, Alabbas Sara Fahad, AlAqeely Mohammed, AlOrabi Ohoud, Al-Mutawa Aliaa, AlOtaibi Maha, Elghannam Madiha Fawazy, Almaani Mohammed, Buabbas Sarah Fadel, Alfilfil Wadiah Alawi M, Alshahrani Mohammed S, Starkopf Joel, Preiser Jean-Charles, Perner Anders, AlMubarak Jumana Hani, Hazem Wafa Mansoor, Albrahim Talal, Al-Dawood Abdulaziz, and the Saudi Critical Care Trials Group
Аннотация
METHODS: In this multicenter randomized trial, critically ill patients will be randomized to receive supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition to achieve a high amount of enteral protein (range of 2-2.4 g/kg/day) or no supplemental enteral protein to achieve a moderate amount of enteral protein (0.8-1.2 g/kg/day). The primary outcome is 90-day all-cause mortality; other outcomes include functional and health-related quality-of-life assessments at 90 days. The study sample size of 2502 patients will have 80% power to detect a 5% absolute risk reduction in 90-day mortality from 30 to 25%. Consistent with international guidelines, this statistical analysis plan specifies the methods for evaluating primary and secondary outcomes and subgroups. Applying this statistical analysis plan to the REPLENISH trial will facilitate unbiased analyses of clinical data.
CONCLUSION: Ethics approval was obtained from the institutional review board, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia (RC19/414/R). Approvals were also obtained from the institutional review boards of each participating institution. Our findings will be disseminated in an international peer-reviewed journal and presented at relevant conferences and meetings.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT04475666 . Registered on July 17, 2020.