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

2024; Springer Science+Business Media; Volume: 25; Issue: 1 Linguagem: Inglês

10.1186/s13063-024-08105-w

1745-6215

Yaseen M. Arabi, Hasan M. Al‐Dorzi, Omar Aldibaasi, Musharaf Sadat, Jesna Jose, Dina Muharib, Haifa Algethamy, Abdulrahman Al‐Fares, Fahad Al-Hameed, Ahmed Mady, Ayman Kharaba, Ali Al Bshabshe, Khalid Maghrabi, Khalid Alghamdi, Ghulam Rasool, Adnan Alghamdi, Ghaleb A. Almekhlafi, Jamal Chalabi, Haifaa Ibrahim AlHumedi, Maram Sakkijha, Norah Khalid Alamrey, Amjad Sami Alaskar, Rabeah Hamad Alhutail, Kaouthar Sifaoui, Rakan Alqahtani, Ahmad S Qureshi, Mohammed Moneer Hejazi, Hatim Arishi, Samah AlQahtani, Amro Mohamed Ghazi, Saleh T. Baaziz, Abeer Othman Azhar, Sara Fahad Alabbas, Mohammed AlAqeely, Ohoud AlOrabi, Aliaa Al-Mutawa, Maha Alotaibi, Madiha Fawazy Elghannam, Mohammed Almaani, Sarah Buabbas, Wadiah Alawi M. Al-Filfil, Mohammed Alshahrani, Joel Starkopf, Jean‐Charles Preiser, Anders Perner, Jumana Hani AlMubarak, Wafa Mansoor Hazem, Talal Albrahim, Abdulaziz Al‐Dawood, Amal Al-Matroud, Brintha Naidu, Vicki Burrow, Salha Al Zayer, Haseena Banu Khan, Afonso Varela, Hatim Arishi, Mohammed Moneer Hejazi, Mohamed Ali Alodat, Rayan Alshayeh, AbdulRehman AlHarthi, Naif Al Qahtani, Yasmeen Ayed AlHejiely, Mada Muzhir AlZahrani, Mohammed Lhmdi, Nouf AlBakhiet, Katrina Baguisa, Huda Mhawisg, Haifa Alghethamy, Liyakat Khan, Moataz Gabr, Nuzhat Shehla, Ohoud AlOrabi, Raghad Malabari, Kholoud Shobragi, Shaymaa Asaas, Madiha Fawazy Elghannam, Beverly Bcuizon, Bander AlAnezi, Christine Joy Anaud, Munir Mustafa Aldammad, Yahia Otaif, Osama Hakami, Arwa AlHusseini, Shahinaz Bashir, Lama Hefni, Samahar Alamoudi, Milyn L. Ansing, Sawsan Albalawi, Manar Alahmadi, Mohammed Humaid Alhumaid, Samar Talal Nouri, Rozeena Huma, K. Mohammed Farhan, Mohamed A. Hussein, Olfa Baji, Abdulrehman Alerw, Khloud Johani, Monera AlEnezi, Ismail Boudrar, Rabiah Atiq, Maali Junid, Maram Yusef, Ahmed Quadri, Khalid Idrees, Mona Bin Mabkoot, Wadiah Alawi M. Al-Filfil, AbdulRehman Fahad Alkraidees, Laila Perlas Asonto,

Child Nutrition and Feeding Issues

The optimal amount and timing of protein intake in critically ill patients are unknown. REPLENISH (Replacing Protein via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial evaluates whether supplemental enteral protein added to standard enteral nutrition to achieve a high amount of enteral protein given from ICU day five until ICU discharge or ICU day 90 as compared to no supplemental enteral protein to achieve a moderate amount of enteral protein would reduce all-cause 90-day mortality in adult critically ill mechanically ventilated patients.