Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial.
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ABSTRACT: Background
Enteral nutrition is part of the treatment of critically ill patients. Administration of enteral nutrition may be associated with signs of intolerance, such as high gastric residual volumes, diarrhea, and vomiting. Clinical trials regarding the effects of the mode of administration of enteral nutrition on the occurrence of these complications have yielded conflicting results. This trial aims to investigate whether the mode of administration of enteral nutrition affects the time to reach nutritional targets, intolerance, and complications.Methods
COINN is a randomized, monocentric study for critically ill adult patients receiving enteral nutrition. Patients will be randomly assigned to two groups receiving (1) continuous or (2) intermittent administration of enteral nutrition. Enhancement of enteral nutrition will depend on signs of tolerance, mainly the gastric residual volume. The primary outcome will be the time to reach the energetic target. Secondary outcomes will be the time to reach the protein target, tolerance, complications, hospital and ICU lengths of stay, and 28-day mortality.Discussion
This trial aims to evaluate whether the mode of application of enteral nutrition affects the time to reach nutritional targets, signs of intolerance, and complications.Trial registration
ClinicalTrials.gov NCT03573453. Registered on 29 June 2018.
SUBMITTER: Hrdy O
PROVIDER: S-EPMC7682133 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Administration of enteral nutrition (EN) in critically ill pediatric patients admitted to the pediatric intensive care unit (PICU) constitutes a major challenge due to the increased risk of complications, as well as the lack of well-trained healthcare professionals. EN is usually delivered via cyclic, continuous, or intermittent feeding; however, a number of potential barriers have been reported in the literature regarding different feeding regimens. The purpose of this review was to assess the effectiveness of continuous and intermittent bolus feeding on critically ill children. A systematic search was conducted in PubMed, Scopus Cochrane Central Register of Controlled Trials (CENTRAL) and a clinical trial registry up to September 2022, including randomized controlled trials (RCTs) published in the English language. Four studies met the inclusion criteria with a total population of 288 patients admitted to the PICU. Three studies were rated with a high risk of bias and one with some concerns. There was high heterogeneity between the studies in regard to the reporting of outcomes. Three studies measured the total time needed to reach prescribed caloric intake with conflicting results, while two studies evaluated the length of stay (LOS) in PICU with no difference between the two arms. One study assessed the time weaning from mechanical ventilation, favoring the bolus group. No data were provided for gastric residual volume (GRV), anthropometric measurements, and biochemical markers. Additional randomized trials with better methodology are needed to assess the efficacy of the two enteral feeding regimens in critically ill PICU patients.
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Project description:The appropriate strategy for enteral feeding remains a matter of debate. We hypothesized that continuous enteral feeding would result in higher rates of achieving target nutrition during the first 7 days compared with intermittent enteral feeding. We conducted an unblinded, single-center, parallel-group, randomized controlled trial involving adult patients admitted to the medical intensive care unit who required mechanical ventilation to determine the efficacy and safety of continuous enteral feeding for critically ill patients compared with intermittent enteral feeding. The primary endpoint was the achievement of ≥80% of the target nutrition requirement during the first 7 days after starting enteral feeding. A total of 99 patients were included in the modified intention-to-treat analysis (intermittent enteral feeding group, n = 49; continuous enteral feeding group, n = 50). The intermittent enteral feeding group and continuous enteral feeding group received 227 days and 226 days of enteral feeding, respectively. The achievement of ≥80% of the target nutrition requirement occurred significantly more frequently in the continuous enteral feeding group than in the intermittent enteral feeding group (65.0% versus 52.4%, respectively; relative risk, 1.24; 95% confidence interval, 1.06-1.45; p = 0.008). For patients undergoing mechanical ventilation, continuous enteral feeding significantly improved the achievement of target nutrition requirements.
| S-EPMC8839656 | biostudies-literature
Project description:ObjectivesThe appropriate strategy for enteral feeding in critically ill patients still remains controversial. Therefore, we conducted this meta-analysis to compare the effect of intermittent versus continuous enteral feeding method for critically ill patients.MethodsElectronic databases including PubMed, Embase, Scopus, and Cochrane Library were searched up to April 10th, 2023 for randomized controlled trials evaluating the effect of intermittent versus continuous enteral feeding for critically ill patients. The primary outcomes were feeding intolerances, including diarrhea, vomiting, distension, constipation, gastric retention, and aspiration pneumonia. The secondary outcomes were mortality in intensive care unit (ICU), length of stay in ICU, and achievement of nutritional goal.ResultsThirteen studies with a total of 884 patients were analyzed in this meta-analysis. Overall, the use of intermittent enteral feeding was associated with higher incidence of diarrhea (OR 1.66, 95%CI 1.13 to 2.43, I2 = 16%) and distension (OR 2.29, 95%CI 1.16 to 4.51, I2 = 0%), lower incidence of constipation (OR 0.58, 95%CI 0.37 to 0.90, I2 = 0%), and longer length of ICU stay (MD 1.09, 95%CI 0.53 to 1.64, I2 = 0%). Moreover, no significant difference was identified for other outcome measures.ConclusionIn critically ill patients, the implementation of intermittent enteral feeding was associated with higher incidence of diarrhea and distension, longer length of ICU stay, but lower occurrence of constipation. Nevertheless, the absence of sufficient high-quality randomized controlled clinical trials precludes any definitive conclusions regarding the optimal approach to enteral feeding in this population. There is an imperative need for more studies to further assess the efficacy of the two enteral feeding strategies.
| S-EPMC10475573 | biostudies-literature
Project description:PURPOSE:To compare endocrine responses to intermittent vs continuous enteral nutrition provision during short-term bed rest. METHODS:Twenty healthy men underwent 7 days of bed rest, during which they were randomized to receive enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre) in a continuous (CONTINUOUS; n?=?10; 24 h day-1 at a constant rate) or intermittent (INTERMITTENT; n?=?10; as 4 meals per day separated by 5 h) pattern. Daily plasma samples were taken every morning to assess metabolite/hormone concentrations. RESULTS:During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42?±?0.38 vs 0.95?±?0.48 nmol L-1, respectively; P?=?0.014) as were insulin concentrations (interaction effect, P?<?0.001) which reached a peak of 369?±?225 pmol L-1 in CONTINUOUS, compared to 94?±?38 pmol L-1 in INTERMITTENT (P?=?0.001). Changes in glucose infusion rate were positively correlated with changes in fasting plasma GLP-1 concentrations (r?=?0.44, P?=?0.049). CONCLUSION:Intermittent enteral nutrition attenuates the progressive rise in plasma leptin and insulinemia seen with continuous feeding during bed rest, suggesting that continuous feeding increases insulin requirements to maintain euglycemia. This raises the possibility that hepatic insulin sensitivity is impaired to a greater extent with continuous versus intermittent feeding during bed rest. To attenuate endocrine and metabolic changes with enteral feeding, an intermittent feeding strategy may, therefore, be preferable to continuous provision of nutrition. This trial was registered on clinicaltrials.gov as NCT02521025.
| S-EPMC7419443 | biostudies-literature
Project description:IntroductionCurrent guidelines on clinical nutrition of ventilated patients in the intensive care unit (ICU) recommend initiating continuous enteral nutrition within 48 hours of ICU admission when feasible. However, discontinuous feeding regimens, alternating feeding and fasting intervals, may have an impact on clinical and patient centred outcomes. The ongoing "Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients" (DC-SCENIC) trial aims to compare standard continuous enteral feeding with daily cyclic enteral feeding over 10 hours to evaluate if implementing a fasting-mimicking diet can decrease organ failure in ventilated patients during the acute phase of ICU management.Methods and analysisDC-SCENIC is a randomised, controlled, multicentre, open-label trial comparing two parallel groups of patients 18 years of age or older receiving invasive mechanical ventilation and having an indication for enteral nutrition through a gastric tube. Enteral feeding is continuous in the control group and administered over 10 hours daily in the intervention group. Both groups receive isocaloric nutrition with 4 g of protein per 100 mL, and have the same 20 kcal/kg/day caloric target. The primary endpoint is the change in the Sequential Organ Failure Assessment score at 7 days compared with the day of inclusion in the study. Secondary outcomes include daily caloric and protein delivery, digestive, respiratory and metabolic tolerance as well as 28-day mortality, duration of mechanical ventilation and ventilator-free days. Outcomes will be analysed on an intention-to-treat basis. Recruitment started in June 2023 in 3 French ICU's and a sample size of 318 patients is expected by February 2026.Ethics and disseminationThis study received approval from the national ethics review board on 8 November 2022 (Comité de Protection des Personnes Sud-Est VI, registration number 2022-A00827-36). Patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT05627167.
| S-EPMC10826523 | biostudies-literature
Project description:BackgroundEnteral nutrition is currently the route of choice for feeding critically ill patients with a functioning gut but delivery is commonly associated with disruptions. Common reasons for interruptions to enteral nutrition are fasting for diagnostic procedures, surgery and airway management. These interruptions result in significant calorie deficits that are associated with increased complications. We aimed to describe the specific interruptions in our patient group and the impact they have on nutrition delivery before and after implementation of a fasting guideline.MethodsA service improvement project was undertaken over two different time points, 1 year apart, to evaluate the effectiveness of a fasting guideline in a general/trauma ICU in a London teaching hospital.ResultsThere were 62 interruptions to enteral nutrition delivery with the first data collection and 64 in the second. Prolonged fasting before and after surgery and airway procedures were initially identified as the two most important causes of delays. Implementation of the fasting guideline resulted in statistical and clinical improvements in reducing fasting for airways procedures. The calorie deficit also statistically and clinically decreased as a result of the guideline.ConclusionsWe conclude that the introduction of a simple guideline stipulating reduced fasting times before ICU procedures can result in less time lost in feed interruptions and improved enteral nutrition delivery.
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Project description:PurposeTo provide evidence-based guidelines for early enteral nutrition (EEN) during critical illness.MethodsWe aimed to compare EEN vs. early parenteral nutrition (PN) and vs. delayed EN. We defined "early" EN as EN started within 48 h independent of type or amount. We listed, a priori, conditions in which EN is often delayed, and performed systematic reviews in 24 such subtopics. If sufficient evidence was available, we performed meta-analyses; if not, we qualitatively summarized the evidence and based our recommendations on expert opinion. We used the GRADE approach for guideline development. The final recommendations were compiled via Delphi rounds.ResultsWe formulated 17 recommendations favouring initiation of EEN and seven recommendations favouring delaying EN. We performed five meta-analyses: in unselected critically ill patients, and specifically in traumatic brain injury, severe acute pancreatitis, gastrointestinal (GI) surgery and abdominal trauma. EEN reduced infectious complications in unselected critically ill patients, in patients with severe acute pancreatitis, and after GI surgery. We did not detect any evidence of superiority for early PN or delayed EN over EEN. All recommendations are weak because of the low quality of evidence, with several based only on expert opinion.ConclusionsWe suggest using EEN in the majority of critically ill under certain precautions. In the absence of evidence, we suggest delaying EN in critically ill patients with uncontrolled shock, uncontrolled hypoxaemia and acidosis, uncontrolled upper GI bleeding, gastric aspirate >500 ml/6 h, bowel ischaemia, bowel obstruction, abdominal compartment syndrome, and high-output fistula without distal feeding access.
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Project description:BackgroundCritically ill patients rapidly develop muscle wasting resulting in sarcopenia, long-term disability and higher mortality. Bolus nutrition (30-60 min period), whilst having a similar incidence of aspiration as continuous feeding, seems to provide metabolic benefits through increased muscle protein synthesis due to higher leucine peaks. To date, clinical evidence on achievement of nutritional goals and influence of bolus nutrition on skeletal muscle metabolism in ICU patients is lacking. The aim of the Pro BoNo study (Protein Bolus Nutrition) is to compare intermittent and continuous enteral feeding with a specific high-protein formula. We hypothesise that target quantity of protein is reached earlier (within 36 h) by an intermittent feeding protocol with a favourable influence on muscle protein synthesis.MethodsPro BoNo is a prospective randomised controlled study aiming to compare the impact of intermittent and continuous enteral feeding on preventing muscle wasting in 60 critically ill patients recruited during the first 48 h after ICU admission. The primary outcome measure is the time until the daily protein target (≥ 1.5 g protein/kg bodyweight/24 h) is achieved. Secondary outcome measures include tolerance of enteral feeding and evolution of glucose, urea and IGF-1. Ultrasound and muscle biopsy of the quadriceps will be performed.DiscussionThe Basel Pro BoNo study aims to collect innovative data on the effect of intermittent enteral feeding of critically ill patients on muscle wasting.Trial registrationClinicalTrials.gov NCT03587870 . Registered on July 16, 2018. Swiss National Clinical Trials Portal SNCTP000003234. Last updated on July 24, 2019.
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Project description:INTRODUCTION:Our aim was to evaluate the impact of hyperproteic hypocaloric enteral feeding on clinical outcomes in critically ill patients, particularly on severity of organic failure measured with the Sequential Organ Failure Assessment (SOFA). MATERIALS AND METHODS:In a double blind clinical trial, 80 critically ill adult patients were randomized to hyperproteic hypocaloric or to isocaloric enteral nutrition; all patients completed follow-up of at least 4 days. Prescribed caloric intake was: Hyperproteic hypocaloric enteral nutrition (15 kcal/kg with 1.7 g/kg of protein) or isocaloric enteral nutrition (25 kcal/kg with 20% of the calories as protein). The main outcome was the differences in delta SOFA at 48 h. Secondary outcomes were intensive care unit (ICU) length of stay, days on ventilator, hyperglycemic events, and insulin requirements. RESULTS:There were no differences in SOFA score at baseline (7.5 (standard deviation (SD) 2.9) vs 6.7 (SD 2.5) P = 0.17). The total amount of calories delivered was similarly low in both groups (12 kcal/kg in intervention group vs 14 kcal/kg in controls), but proteic delivery was significantly different (1.4 vs 0.76 g/kg, respectively P ? 0.0001). The intervention group showed an improvement in SOFA score at 48 h (delta SOFA 1.7 (SD 1.9) vs 0.7 (SD 2.8) P = 0.04) and less hyperglycemic episodes per day (1.0 (SD 1.3) vs 1.7 (SD 2.5) P = 0.017). DISCUSSION:Enteral hyperproteic hypocaloric nutrition therapy could be associated with a decrease in multiple organ failure measured with SOFA score. We also found decreased hyperglycemia and a trend towards less mechanical ventilation days and ICU length of stay.
| S-EPMC3902568 | biostudies-literature
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.
| S-EPMC4156550 | biostudies-literature