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Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial.

ABSTRACT: BACKGROUND:Malnutrition is one of the crucial factors associated with poor prognosis in critical ill patients, yet a significant evidence gap surrounds the management of initial enteral feeding in severe stroke. The Optimizing Early Enteral Nutrition in Severe Stroke (OPENS) trial will compare a strategy of modified full enteral nutrition (EN) (standard full EN in conjunction with prokinetic drug) and a strategy of permissive underfeeding (40 to 60% of estimated caloric requirements) with standard full EN (advancement to target nutrition goals) in patients with severe stroke. METHODS:The OPENS trial is a multicenter randomized controlled study. A total of 600 adult patients with severe stroke will be enrolled in 12 study sites in China, and randomized to standard full EN, modified full EN, or permissive underfeeding. The primary outcome measurement is the proportion of participants with a poor outcome (modified Rankin Scale ?3) at day 90 of enrollment. Secondary outcomes include incidence rates of complications during hospitalization, disability at hospital discharge, and the ability of activities of daily living at day 90 of enrollment. The relationship between intervention and the primary outcome will be analyzed using multivariate logistic regression adjusted for study site, demographics, and baseline characteristics. DISCUSSION:The OPENS trial will explore the optimum initial feeding strategy for acute severe stroke. This trial is, therefore, an important step in bridging the evidence gap surrounding the enteral feeding for patients with severe stroke during the first week of hospitalization. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02982668 ; First Posted: December 5, 2016.

SUBMITTER: Yuan F

PROVIDER: S-EPMC6371599 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial.

Yuan Fang F Yang Fang F Zhang Wei W Jia Yi Y Ma Yaling Y Qu Yongcai Y Wang Xinglai X Huo Kang K Wang Chengkai C Yuan Xiangjun X Song Chaohui C Zhang Bei B Jiang Wen W

BMC neurology 20190212 1

<h4>Background</h4>Malnutrition is one of the crucial factors associated with poor prognosis in critical ill patients, yet a significant evidence gap surrounds the management of initial enteral feeding in severe stroke. The Optimizing Early Enteral Nutrition in Severe Stroke (OPENS) trial will compare a strategy of modified full enteral nutrition (EN) (standard full EN in conjunction with prokinetic drug) and a strategy of permissive underfeeding (40 to 60% of estimated caloric requirements) wit ...[more]

PMID: 30755171

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Project description:BackgroundNutritional problems in the early stages of severe burns are prominent and seriously affect the clinical outcomes of patients. Our aim is to analyze the effects of early enteral nutrition (EEN) in patients with severe burns.MethodsIn this study, relevant articles were searched in 8 English and Chinese data, with a time limit from the creation of the database to June 2023. Two researchers independently completed the search, screening and quality assessment of the articles. We conducted a systematic review and meta-analysis of randomized controlled trials that examined EEN therapy in people with severe burns. We compared the effects of EEN and non-EEN therapy in severely burned patients. The outcomes were mortality, gastrointestinal complications, nutritional indicators, gastrointestinal hormones, sepsis, length of hospital stay and wound healing time. Categorical variables were expressed as OR and 95% CI was calculated, and continuous variables were expressed as MD and 95% CI was calculated. The protocol for this systematic review was registered in PROSPERO on May 12, 2023 (identifier CRD42023422895).ResultsNineteen studies with a total of 1066 participants met the inclusion criteria. When comparing EEN therapy with non-EEN therapy, the experiment group had significantly lower mortality [OR = 0.39, 95% CI (0.20, 0.74), P = .004], lower wound healing time [MD = -10.77, 95% CI (-13.66,-7.88), P < .00001], fewer gastrointestinal complications [OR = 0.18, 95% CI (0.09, 0.36), P < .00001], lower rates of gastrointestinal hemorrhage [OR = 0.12, 95% CI (0.04, 0.36), P = .0001], lower rates of sepsis [OR = 0.40, 95% CI (0.24, 0.66), P = .0005], shorter length of hospital stay [MD = -12.08, 95% CI (-13.61, 9.19-10.56), P < .00001], and higher prealbumin levels [MD = 29.04, 95% CI (21.98, 36.10), P < .00001], higher total albumin levels [MD = 6.74, 95% CI (4.29, 9.19), P < .00001], and gastrin levels [MD = 15.93, 95% CI (10.12, 21.73), P < .00001]. However, there was no significant difference in albumin between the 2 groups [MD = 2.62, 95% CI (-0.30, 5.55), P = .08] or motilin levels [MD = 12.48, 95% CI (-43.59, 68.56), P = .66].ConclusionsEEN plays an important role in the rehabilitation of patients with severe burns. EEN is beneficial to reduce complications and the length of hospital stay, maintain organ function, optimize the nutritional status of patients, promote wound healing, and improve the survival rate 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.

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Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial.

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Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial.

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