Yaseen M Arabi1, Hasan M Al-Dorzi2, Hani Tamim3, Musharaf Sadat4, Fahad Al-Hameed5, Adnan AlGhamdi6, Ghaleb A Al Mekhlafi7, Ghulam Rasool8, Lara Afesh9, Maram Hasan Sakkijha10, Norah Khalid Alamrey11, Raghad Malebari12, Rabeah Hamad Alhutail13, Abdulaziz Al-Dawood14. 1. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: yaseenarabi@yahoo.com. 2. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: aldorzih@yahoo.com. 3. College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; Department of Emergency Medicine, American University of Beirut, Lebanon. Electronic address: Hani_t@hotmail.com. 4. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: sadatmu@ngha.med.sa. 5. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia; King Abdullah International Medical Research Center, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. Electronic address: Hameedf@ngha.med.sa. 6. Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia. Electronic address: sbb1971@hotmail.com. 7. Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia. Electronic address: gmekhlafi@yahoo.com. 8. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia; King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. Electronic address: GulamRA@ngha.med.sa. 9. King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: afeshla@ngha.med.sa. 10. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: SakkijhaM@ngha.med.sa. 11. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: alamreyno@ngha.med.sa. 12. Clinical Nutrition Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia; King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. Electronic address: malebarira@ngha.med.sa. 13. Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia. Electronic address: Rabaa34@gmail.com. 14. Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: dawooda@ngha.med.sa.
Abstract
BACKGROUND AND AIMS: The optimal amount of protein intake in critically ill patients is unclear. The objective of this pilot trial is to assess the feasibility of a large randomized controlled trial testing higher versus lower protein intake in critically ill patients. METHODS: In this pilot randomized controlled trial (REPLacing Protein via Enteral Nutrition in a Stepwise ApproacH in critically ill patients: A pilot randomized controlled trial (REPLENISH pilot trial), critically ill patients underwent 2-step screening for eligibility on ICU day 1 and 5. Patients with renal disease were excluded. Eligible patients were randomized into REPLENISH group (target protein 1.8-2.2 g kg/day) and Standard group (target protein 0.8-1.0 g/kg/day) from day 6-14 after ICU admission. Dietitians adjusted caloric and protein intake throughout the study period (Day 1-14) to maintain similar caloric targets of permissive underfeeding (40-60% of estimated energy expenditure) in both study groups. RESULTS: Of 704 patients screened at 3 centers in Saudi Arabia from May 2018 to May 2019, only 63 (8.9%) were eligible and 40 (5.7% of screened) were randomized with an average of 2 patients enrolled in the trial per month. Among eligible patients, the consenting rate was high at 89%. During the intervention period, patients in the REPLENISH group (N = 21) had a modestly higher protein intake (median of 1.30 g/kg/day (Q1 Q3: 1.11, 1.57)) than those in the standard group (median of 0.77 g/kg/day (Q1 Q3: 0.57, 1.00); P = 0.0004). Only 31.4% of patients in the whole cohort had >80% of prescribed protein. The duration of daily interruption of feeding was almost 4 h in both groups. The 90-day mortality for the patient study cohort was 20.5%. Anthropometric and muscle strength measurements were performed in less than 50% of patients. CONCLUSIONS: This pilot trial highlighted several areas for improvement in the study protocol before launching a large randomized controlled trial. The restrictive eligibility criteria, the complex adjustments of protein and energy and some of the outcome measurements were identified as targets for modifications, to improve enrollment and generalizability and to enhance adherence to study interventions and measurements. TRIAL REGISTRATION: CLINICALTRIALS. GOV IDENTIFIER: NCT03480555.
RCT Entities:
BACKGROUND AND AIMS: The optimal amount of protein intake in critically illpatients is unclear. The objective of this pilot trial is to assess the feasibility of a large randomized controlled trial testing higher versus lower protein intake in critically illpatients. METHODS: In this pilot randomized controlled trial (REPLacing Protein via Enteral Nutrition in a Stepwise ApproacH in critically illpatients: A pilot randomized controlled trial (REPLENISH pilot trial), critically illpatients underwent 2-step screening for eligibility on ICU day 1 and 5. Patients with renal disease were excluded. Eligible patients were randomized into REPLENISH group (target protein 1.8-2.2 g kg/day) and Standard group (target protein 0.8-1.0 g/kg/day) from day 6-14 after ICU admission. Dietitians adjusted caloric and protein intake throughout the study period (Day 1-14) to maintain similar caloric targets of permissive underfeeding (40-60% of estimated energy expenditure) in both study groups. RESULTS: Of 704 patients screened at 3 centers in Saudi Arabia from May 2018 to May 2019, only 63 (8.9%) were eligible and 40 (5.7% of screened) were randomized with an average of 2 patients enrolled in the trial per month. Among eligible patients, the consenting rate was high at 89%. During the intervention period, patients in the REPLENISH group (N = 21) had a modestly higher protein intake (median of 1.30 g/kg/day (Q1 Q3: 1.11, 1.57)) than those in the standard group (median of 0.77 g/kg/day (Q1 Q3: 0.57, 1.00); P = 0.0004). Only 31.4% of patients in the whole cohort had >80% of prescribed protein. The duration of daily interruption of feeding was almost 4 h in both groups. The 90-day mortality for the patient study cohort was 20.5%. Anthropometric and muscle strength measurements were performed in less than 50% of patients. CONCLUSIONS: This pilot trial highlighted several areas for improvement in the study protocol before launching a large randomized controlled trial. The restrictive eligibility criteria, the complex adjustments of protein and energy and some of the outcome measurements were identified as targets for modifications, to improve enrollment and generalizability and to enhance adherence to study interventions and measurements. TRIAL REGISTRATION: CLINICALTRIALS. GOV IDENTIFIER: NCT03480555.