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

Yaseen M Arabi; Hasan M Al-Dorzi; Musharaf Sadat; Dina Muharib; Haifa Algethamy; Fahad Al-Hameed; Ahmed Mady; Adnan AlGhamdi; Ghaleb A Almekhlafi; Abdulrahman A Al-Fares; Ayman Kharaba; Ali Al Bshabshe; Khalid Maghrabi; Khalid Al Ghamdi; Ghulam Rasool; Jamal Chalabi; Haifaa Ibrahim AlHumedi; Maram Hasan Sakkijha; Norah Khalid Alamrey; Rabeah Hamad Alhutail; Kaouthar Sifaoui; Mohammed Almaani; 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; Omar Aldibaasi; Jesna Jose; Joel Starkopf; Jean-Charles Preiser; Anders Perner; Abdulaziz Al-Dawood; Saudi Critical Care Trials Group

doi:10.1186/s13063-023-07507-6

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

Yaseen M Arabi^*, Hasan M Al-Dorzi, Musharaf Sadat, Dina Muharib, Haifa Algethamy, Fahad Al-Hameed, Ahmed Mady, Adnan AlGhamdi, Ghaleb A Almekhlafi, Abdulrahman A Al-Fares, Ayman Kharaba, Ali Al Bshabshe, Khalid Maghrabi, Khalid Al Ghamdi, Ghulam Rasool, Jamal Chalabi, Haifaa Ibrahim AlHumedi, Maram Hasan Sakkijha, Norah Khalid Alamrey, Rabeah Hamad AlhutailKaouthar Sifaoui, Mohammed Almaani, 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, Omar Aldibaasi, Jesna Jose, Joel Starkopf, Jean-Charles Preiser, Anders Perner, Abdulaziz Al-Dawood, Saudi Critical Care Trials Group

^*Corresponding author af dette arbejde

Afdeling for Intensiv Behandling i Center for Kræft og Organsygdomme

5 Citationer (Scopus)

Abstract

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.

Originalsprog	Engelsk
Artikelnummer	485
Tidsskrift	Trials
Vol/bind	24
Udgave nummer	1
ISSN	1745-6215
DOI	https://doi.org/10.1186/s13063-023-07507-6
Status	Udgivet - 30 jul. 2023

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10.1186/s13063-023-07507-6

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Arabi, Y. M., Al-Dorzi, H. M., Sadat, M., Muharib, D., Algethamy, H., Al-Hameed, F., Mady, A., AlGhamdi, A., Almekhlafi, G. A., Al-Fares, A. A., Kharaba, A., Al Bshabshe, A., Maghrabi, K., Al Ghamdi, K., Rasool, G., Chalabi, J., AlHumedi, H. I., Sakkijha, M. H., Alamrey, N. K., ... Saudi Critical Care Trials Group (2023). Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: the REPLENISH randomized clinical trial protocol. Trials, 24(1), Artikel 485. https://doi.org/10.1186/s13063-023-07507-6

Arabi, YM, Al-Dorzi, HM, Sadat, M, Muharib, D, Algethamy, H, Al-Hameed, F, Mady, A, AlGhamdi, A, Almekhlafi, GA, Al-Fares, AA, Kharaba, A, Al Bshabshe, A, Maghrabi, K, Al Ghamdi, K, Rasool, G, Chalabi, J, AlHumedi, HI, Sakkijha, MH, Alamrey, NK, Alhutail, RH, Sifaoui, K, Almaani, M, Alqahtani, R, Qureshi, AS, Hejazi, MM, Arishi, H, AlQahtani, S, Ghazi, AM, Baaziz, ST, Azhar, AO, Alabbas, SF, AlAqeely, M, AlOrabi, O, Al-Mutawa, A, AlOtaibi, M, Aldibaasi, O, Jose, J, Starkopf, J, Preiser, J-C, Perner, A, Al-Dawood, A & Saudi Critical Care Trials Group 2023, 'Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: the REPLENISH randomized clinical trial protocol', Trials, bind 24, nr. 1, 485. https://doi.org/10.1186/s13063-023-07507-6

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

abstract = "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.",

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

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doi = "10.1186/s13063-023-07507-6",

language = "English",

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T1 - Replacing protein via enteral nutrition in a stepwise approach in critically ill patients

T2 - the REPLENISH randomized clinical trial protocol

AU - Arabi, Yaseen M

AU - Al-Dorzi, Hasan M

AU - Sadat, Musharaf

AU - Muharib, Dina

AU - Algethamy, Haifa

AU - Al-Hameed, Fahad

AU - Mady, Ahmed

AU - AlGhamdi, Adnan

AU - Almekhlafi, Ghaleb A

AU - Al-Fares, Abdulrahman A

AU - Kharaba, Ayman

AU - Al Bshabshe, Ali

AU - Maghrabi, Khalid

AU - Al Ghamdi, Khalid

AU - Rasool, Ghulam

AU - Chalabi, Jamal

AU - AlHumedi, Haifaa Ibrahim

AU - Sakkijha, Maram Hasan

AU - Alamrey, Norah Khalid

AU - Alhutail, Rabeah Hamad

AU - Sifaoui, Kaouthar

AU - Almaani, Mohammed

AU - Alqahtani, Rakan

AU - Qureshi, Ahmad S

AU - Hejazi, Mohammed Moneer

AU - Arishi, Hatim

AU - AlQahtani, Samah

AU - Ghazi, Amro Mohamed

AU - Baaziz, Saleh T

AU - Azhar, Abeer Othman

AU - Alabbas, Sara Fahad

AU - AlAqeely, Mohammed

AU - AlOrabi, Ohoud

AU - Al-Mutawa, Aliaa

AU - AlOtaibi, Maha

AU - Aldibaasi, Omar

AU - Jose, Jesna

AU - Starkopf, Joel

AU - Preiser, Jean-Charles

AU - Perner, Anders

AU - Al-Dawood, Abdulaziz

AU - Saudi Critical Care Trials Group

PY - 2023/7/30

Y1 - 2023/7/30

N2 - 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.

AB - 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.

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U2 - 10.1186/s13063-023-07507-6

DO - 10.1186/s13063-023-07507-6

M3 - Journal article

C2 - 37518058

SN - 1745-6215

VL - 24

JO - Trials

JF - Trials

IS - 1

M1 - 485

ER -

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

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