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

被引：3

作者：

Arabi, Yaseen M. ^{[1
]}

Al-Dorzi, Hasan M. ^{[1
]}

Aldibaasi, Omar ^{[2
]}

Sadat, Musharaf ^{[1
]}

Jose, Jesna ^{[2
]}

Muharib, Dina ^{[3
]}

Algethamy, Haifa ^{[4
]}

Al-Fares, Abdulrahman A. ^{[5
]}

Al-Hameed, Fahad ^{[6
]}

Mady, Ahmed ^{[3
,7
]}

Kharaba, Ayman ^{[8
,9
]}

Al Bshabshe, Ali ^{[10
]}

Maghrabi, Khalid ^{[11
]}

AlGhamdi, Khalid ^{[11
]}

Rasool, Ghulam ^{[7
]}

AlGhamdi, Adnan ^{[12
]}

Almekhlafi, Ghaleb. A. ^{[13
,14
]}

Chalabi, Jamal ^{[15
]}

AlHumedi, Haifaa Ibrahim ^{[1
]}

Sakkijha, Maram Hasan ^{[1
]}

Alamrey, Norah Khalid ^{[1
]}

Alaskar, Amjad Sami ^{[1
]}

Alhutail, Rabeah Hamad ^{[13
]}

Sifaoui, Kaouthar ^{[8
,9
]}

AlQahtani, Rakan ^{[15
]}

Qureshi, Ahmad S. ^{[16
]}

Hejazi, Mohammed Moneer ^{[1
]}

Arishi, Hatim ^{[1
]}

AlQahtani, Samah ^{[1
]}

Ghazi, Amro Mohamed ^{[1
]}

Baaziz, Saleh T. ^{[4
]}

Azhar, Abeer Othman ^{[4
]}

Alabbas, Sara Fahad ^{[4
]}

AlAqeely, Mohammed ^{[3
]}

AlOrabi, Ohoud ^{[6
]}

Al-Mutawa, Aliaa ^{[5
]}

AlOtaibi, Maha ^{[3
]}

Elghannam, Madiha Fawazy ^{[12
]}

Almaani, Mohammed ^{[17
]}

Buabbas, Sarah Fadel ^{[18
]}

Alfilfil, Wadiah Alawi M. ^{[19
]}

Alshahrani, Mohammed S. ^{[20
]}

Starkopf, Joel ^{[21
]}

Preiser, Jean-Charles ^{[22
]}

Perner, Anders ^{[23
]}

AlMubarak, Jumana Hani ^{[18
]}

Hazem, Wafa Mansoor ^{[19
]}

Albrahim, Talal ^{[20
]}

Al-Dawood, Abdulaziz ^{[1
]}

机构：

[1] King Saud Bin Abdulaziz Univ Hlth Sci, Coll Med, King Abdullah Int Med Res Ctr, Intens Care Dept,King Abdulaziz Med City,Minist Na, Riyadh, Saudi Arabia

[2] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Riyadh, Saudi Arabia

[3] Intens Care Dept, King Saud Med City, Riyadh, Saudi Arabia

[4] King Abdulaziz Univ, King Abdulaziz Univ Hosp, Dept Anesthesia & Crit Care, Jeddah, Saudi Arabia

[5] Al Amiri Hosp, Dept Anesthesia Crit Care Med & Pain Med, Minist Hlth, Kuwait, Kuwait

[6] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Intens Care Dept, Intens Care Dept,Minist Natl Guard Hlth Affairs, Jeddah, Saudi Arabia

[7] Tanta Univ Hosp, Dept Anesthesiol & Surg Intens Care, Tanta, Egypt

[8] King Fahad Hosp, Pulm Dept, Crit Care Units Madinah Reg, Minist Hlth, Madinah, Saudi Arabia

[9] Minist Hlth, King Fahad Hosp, Crit Care Dept, Crit Care Units Madinah Reg, Madinah, Saudi Arabia

[10] King Khalid Univ, Aseer Cent Hosp, Dept Crit Care Med, Abha, Saudi Arabia

[11] King Faisal Specialist Hosp & Res Ctr, Internal Med, Crit Care, Riyadh, Saudi Arabia

[12] King Faisal Specialist Hosp & Res Ctr, Internal Med, Crit Care, Jeddah, Saudi Arabia

[13] Dept Intens Care Serv, Prince Sultan Mil Med City, Riyadh, Saudi Arabia

[14] Intens Care Dept, King Salman Bin Abdulaziz Med City, Madinah, Saudi Arabia

[15] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Intens Care Dept, King Abdulaziz Med City,AlAhsa Minist Natl Guard H, Riyadh, Saudi Arabia

[16] King Saud Bin Abdulaziz Univ Hlth Sci, Prince Mohammed Bin Abdulaziz Hosp, King Abdullah Int Med Res Ctr, Intens Care Dept,Minist Natl Guard Hlth Affairs, Madinah, Saudi Arabia

[17] Adult Crit Care Serv, King Fahad Med City, Riyadh, Saudi Arabia

[18] Jaber Al Ahmed Al Sabah Hosp, Dept Anesthesia Crit Care & Pain Med, Kuwait, Kuwait

[19] Prince Mohammed Bin Abdulaziz Hosp, Dept Intens Care, Riyadh, Saudi Arabia

[20] King Fahad Hosp Univ, Imam Abdulrahman Bin Faisal Univ, Dept Emergency & Crit Care, Al Khobar, Saudi Arabia

[21] Univ Tartu, Tartu Univ Hosp, Clin Anaesthesiol & Intens Care, Tartu, Estonia

[22] Erasme Univ Hosp, Dept Intens Care, Brussels, Belgium

[23] Univ Copenhagen, Rigshosp, Rigshospitalet, Copenhagen, Denmark

来源：

TRIALS | 2024年 / 25卷 / 01期

关键词：

Critical illness; Protein; Statistical analysis plan; Randomized clinical trial; Nutrition; BODY-MASS INDEX; INTENSIVE-CARE; SERUM-PREALBUMIN; CRITICAL ILLNESS; MULTICENTER; OUTCOMES; ENERGY; RISK; MORTALITY; PROVISION;

D O I：

10.1186/s13063-024-08105-w

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background 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.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.

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