Dataset Information

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.

SUBMITTER: Arabi YM

PROVIDER: S-EPMC10388494 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Arabi Yaseen M YM Al-Dorzi Hasan M HM Sadat Musharaf M Muharib Dina D Algethamy Haifa H Al-Hameed Fahad F Mady Ahmed A AlGhamdi Adnan A Almekhlafi Ghaleb A GA Al-Fares Abdulrahman A AA Kharaba Ayman A Al Bshabshe Ali A Maghrabi Khalid K Al Ghamdi Khalid K Rasool Ghulam G Chalabi Jamal J AlHumedi Haifaa Ibrahim HI Sakkijha Maram Hasan MH Alamrey Norah Khalid NK Alhutail Rabeah Hamad RH Sifaoui Kaouthar K Almaani Mohammed M Alqahtani Rakan R Qureshi Ahmad S AS Hejazi Mohammed Moneer MM Arishi Hatim H AlQahtani Samah S Ghazi Amro Mohamed AM Baaziz Saleh T ST Azhar Abeer Othman AO Alabbas Sara Fahad SF AlAqeely Mohammed M AlOrabi Ohoud O Al-Mutawa Aliaa A AlOtaibi Maha M Aldibaasi Omar O Jose Jesna J Starkopf Joel J Preiser Jean-Charles JC Perner Anders A Al-Dawood Abdulaziz A

Trials 20230730 1

<h4>Background</h4>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 pro ...[more]

PMID: 37518058

Similar Datasets

Project description:ObjectivesTo evaluate the impact of implementing an enteral nutrition algorithm on achieving optimal enteral nutrition delivery in the PICU.DesignProspective pre/post implementation audit of enteral nutrition practices.SettingOne 29-bed medical/surgical PICU in a freestanding, university-affiliated children's hospital.PatientsConsecutive patients admitted to the PICU over two 4-week periods pre and post implementation, with a stay of more than 24 hours who received enteral nutrition.InterventionsBased on the results of our previous study, we developed and systematically implemented a stepwise, evidence and consensus-based algorithm for initiating, advancing, and maintaining enteral nutrition in critically ill children. Three months after implementation, we prospectively recorded clinical characteristics, nutrient delivery, enteral nutrition interruptions, parenteral nutrition use, and ability to reach energy goal in eligible children over a 4-week period. Clinical and nutritional variables were compared between the pre and postintervention cohorts. Time to achieving energy goal was analyzed using Kaplan-Meier statistical analysis.Measurements and main resultsEighty patients were eligible for this study and were compared to a cohort of 80 patients in the preimplementation audit. There were no significant differences in median age, gender, need for mechanical ventilation, time to initiating enteral nutrition, or use of postpyloric feeding between the two cohorts. We recorded a significant decrease in the number of avoidable episodes of enteral nutrition interruption (3 vs 51, p < 0.0001) and the prevalence and duration of parenteral nutrition dependence in patients with avoidable enteral nutrition interruptions in the postintervention cohort. Median time to reach energy goal decreased from 4 days to 1 day (p < 0.0001), with a higher proportion of patients reaching this goal (99% vs 61%, p = 0.01).ConclusionsThe implementation of an enteral nutrition algorithm significantly improved enteral nutrition delivery and decreased reliance on parenteral nutrition in critically ill children. Energy intake goal was reached earlier in a higher proportion of patients.

Project description:BackgroundThe state-of-the-art nutrition used for critically ill children is based essentially on expert opinion and extrapolations from adult studies or on studies in non-critically ill children. In critically ill adults, withholding parenteral nutrition (PN) during the first week in ICU improved outcome, as compared with early supplementation of insufficient enteral nutrition (EN) with PN. We hypothesized that withholding PN in children early during critical illness reduces the incidence of new infections and accelerates recovery.Methods/designThe Pediatric Early versus Late Parenteral Nutrition in Intensive Care Unit (PEPaNIC) study is an investigator-initiated, international, multicenter, randomized controlled trial (RCT) in three tertiary referral pediatric intensive care units (PICUs) in three countries on two continents. This study compares early versus late initiation of PN when EN fails to reach preset caloric targets in critically ill children. In the early-PN (control, standard of care) group, PN comprising glucose, lipids and amino acids is administered within the first days to reach the caloric target. In the late-PN (intervention) group, PN completing EN is only initiated beyond PICU-day 7, when EN fails. For both study groups, an early EN protocol is applied and micronutrients are administered intravenously. The primary assessor-blinded outcome measures are the incidence of new infections during PICU-stay and the duration of intensive care dependency. The sample size (n = 1,440, 720 per arm) was determined in order to detect a 5% absolute reduction in PICU infections, with at least 80% 1-tailed power (70% 2-tailed) and an alpha error rate of 5%. Based on the actual incidence of new PICU infections in the control group, the required sample size was confirmed at the time of an a priori- planned interim-analysis focusing on the incidence of new infections in the control group only.DiscussionClinical evidence in favor of early administration of PN in critically ill children is currently lacking, despite potential benefit but also known side effects. This large international RCT will help physicians to gain more insight in the clinical effects of omitting PN during the first week of critical illness in children.Trial registrationClinicalTrials.gov: NCT01536275 on 16 February 2012.

Project description:BackgroundInflammation and immobility are the most relevant mechanisms that alter protein synthesis and increase protein breakdown. Protein catabolism is associated with morbidity and mortality in critically ill children.ObjectiveTo demonstrate the effectiveness of the routinely used enteral nutrition support guideline in preventing muscle breakdown in critically ill children.MethodsA prospective cohort study was conducted in the pediatric intensive care unit (PICU) of a tertiary care hospital. Critically ill children (aged 1 month to 15 years) admitted to the PICU were enrolled. All patients were assessed for nutritional status and nutritional requirement. Enteral nutrition support following the guideline was initiated within the first 24 hours if no contraindication. The calorie target was defined either by direct measurement from indirect calorimetry or estimated from Schofield equation with protein target at least 1.5 g/kg/day. Anthropometric assessments and body composition measurements by bioelectrical impedance analysis (BIA) were examined at baseline and on the seventh day of the PICU admission.ResultsSixty-three patients were enrolled in the study. The most common age group was 1-5 years old (38.1%). The length of PICU stay was 9.1 (SD = 12.7) days. Respiratory problems were the major cause of PICU admission (50.8%). Mechanical ventilation was required in 55.6% of the patients with the average duration of 6.3 (SD = 12.4) days. Undernutrition was found in 36.5% of the patients. Enteral feeding was the major route of nutrition support (95.2%). After the first week of admission, muscle mass was significantly preserved (p < 0.01). All patients received the nutrition support at their target energy and protein goal within the first week. The enteral feeding-related complication was reported in 1.6% of the patients.ConclusionProtein catabolism during critically ill period can be minimized by optimal nutrition support. Nutrition practice using the enteral nutrition support guideline was effective in helping critically ill children reach their target caloric and protein intake.

Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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