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: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: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.
| S-EPMC5606376 | biostudies-literature
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.
| S-EPMC5323492 | biostudies-literature
Project description:BACKGROUND:Critically 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. METHODS:Pro 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. DISCUSSION:The Basel Pro BoNo study aims to collect innovative data on the effect of intermittent enteral feeding of critically ill patients on muscle wasting. TRIAL REGISTRATION:ClinicalTrials.gov NCT03587870 . Registered on July 16, 2018. Swiss National Clinical Trials Portal SNCTP000003234. Last updated on July 24, 2019.
| S-EPMC7449093 | biostudies-literature
Project description:To evaluate the impact of implementing an enteral nutrition algorithm on achieving optimal enteral nutrition delivery in the PICU.Prospective pre/post implementation audit of enteral nutrition practices.One 29-bed medical/surgical PICU in a freestanding, university-affiliated children's hospital.Consecutive 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.Based 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.Eighty 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).The 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.
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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.
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Project description:Extended infusion of piperacillin/tazobactam over 4 h has been proposed as an alternate mode of administration to the 30-min intermittent infusion to optimize treatment effects in patients with gram-negative bacterial infections. The study aimed to evaluate the extended infusion regimen of piperacillin/tazobactam in standings of efficacy, safety, and cost to the intermittent one in the treatment of gram-negative bacterial infections. A prospective randomized comparative study was performed on 53 patients, 27 in the intermittent infusion group and 26 in the extended infusion group. The primary outcome was the mean number of days to clinical success and the percentage of patients who were clinically cured after treatment. The secondary outcomes included mortality, readmission within 30-days, and cost-effectiveness analysis based on the mean number of days to clinical success. The clinical success rate was comparable in the two groups. Days on extended infusion were significantly lower than intermittent infusion (5.7 vs 8.9 days, respectively, p = 0.0001) as well as days to clinical success (4.6 vs 8.5 days, respectively, p = 0.026). The extended infusion was superior to the intermittent infusion regarding cost-effectiveness ratio ($1835.41 and $1914.09/expected success, respectively). The more cost-effective regimen was the extended infusion. Both regimens had comparable clinical and microbiological outcomes.
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Project description:Background: Early intervention with enteral nutrition (EN) is the standard of care in many medical intensive care units (ICUs). However, few studies have addressed the use of early EN for critically ill patients in the cardiac ICU (CICU). In this study we explored the indications for early EN for patients admitted to a CICU. Methods and Results: This retrospective observational study included 63 consecutive patients admitted to the CICU who were diagnosed with cardiovascular disease. Early EN was initiated in these patients as per the hospital's nutrition protocol. Mean Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores at admission were 18.8 and 9.1, respectively. All patients were admitted to the medical CICU with a diagnosis of cardiovascular disease and/or cardiopulmonary arrest. Enteral feeding was initiated in 59 patients (94%) within 5 days of admission. Fifty-two patients (83%) achieved the energy intake goal at Day 7 of their CICU admission either by enteral feeding or oral intake; 49 patients (78%) survived to time of discharge. The patients experienced several minor complications, including minor reflux (4 patients; 6%) and diarrhea (8 patients; 13%). None of the patients developed aspiration pneumonia or bowel ischemia. Conclusions: The present retrospective observational study indicates that early EN for critically ill patients in a medical CICU can be achieved safely with no major complications.
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Project description:AimTo assess the feasibility, tolerance and effectiveness of enteral nutrition in critically ill patients receiving invasive mechanical ventilation in the prone position for severe Acute Respiratory Distress Syndrome (ARDS).MethodsProspective observational study conducted in a multidisciplinary critical care unit of a tertiary care hospital from January 2013 until July 2015. All patients with ARDS who received invasive mechanical ventilation in prone position during the study period were included. Patients' demographics, severity of illness (Acute Physiology and Chronic Health Evaluation (APACHE II) score), baseline markers of nutritional status (subjective global assessment (SGA) and body mass index), details of nutrition delivery during prone and supine hours and outcomes (Length of stay and discharge status) were recorded.ResultsFifty-one patients met inclusion criteria out of whom four patients were excluded from analysis since they did not receive any enteral nutrition due to severe hemodynamic instability. The mean age of patients was 46.4 ± 12.9 years, with male:female ratio of 7:3. On admission, SGA revealed moderate malnutrition in 51% of patients and the mean APACHE II score was 26.8 ± 9.2. The average duration of prone ventilation per patient was 60.2 ± 30.7 h. All patients received continuous nasogastric/orogastric feeds. The mean calories (kcal/kg/day) and protein (g/kg/day) prescribed in the supine position were 24.5 ± 3.8 and 1.1 ± 0.2 while the mean calories and protein prescribed in prone position were 23.5 ± 3.6 and 1.1 ± 0.2, respectively. Percentage of prescribed calories received by patients in supine position was similar to that in prone position (83.2% vs. 79.6%; P = 0.12). Patients received a higher percentage of prescribed protein in supine compared to prone position (80.8% vs. 75%, P = 0.02). The proportion of patients who received at least 75% of the caloric and protein goals was 37 (78.7%) and 37 (78.7%) in supine and 32 (68.1%) and 21 (44.6%) in prone position.ConclusionIn critically ill patients receiving invasive mechanical ventilation in the prone position, enteral nutrition with nasogastric/orogastric feeding is feasible and well tolerated. Nutritional delivery of calories and proteins in prone position is comparable to that in supine position.
| S-EPMC7890761 | biostudies-literature
Project description:Malnutrition is a frequent problem associated with detrimental clinical outcomes in critically ill patients. To avoid malnutrition, most studies focus on the prevention of inadequate nutrition delivery, whereas little attention is paid to the potential role of exocrine pancreatic insufficiency (EPI). In this trial, we aim to evaluate the prevalence of EPI and identify its potential risk factors in critically ill adult patients without preexisting pancreatic diseases.In this prospective cross-sectional study, we recruited 563 adult patients with critical illnesses. All details of the patients were documented, stool samples were collected three to five days following the initiation of enteral nutrition, and faecal elastase 1 (FE-1) concentrations were assayed using an enzyme-linked immunosorbent assay kit. Blood samples were also taken to determine serum amylase and lipase activity.The percentages of recruited patients with EPI (FE-1 concentration <200 ?g/g) and severe EPI (FE-1 concentration <100 ?g/g) were 52.2% and 18.3%, respectively. The incidences of steatorrhea were significantly different (P < 0.05) among the patients without EPI, with moderate EPI (FE-1 concentration = 100 to 200 ?g/g) and severe EPI (FE-1 concentration < 100 ?g/g). Both multivariate logistic regression analysis and z-tests indicated that the occurrence of EPI was closely associated with shock, sepsis, diabetes, cardiac arrest, hyperlactacidemia, invasive mechanical ventilation and haemodialysis.More than 50% of critically ill adult patients without primary pancreatic diseases had EPI, and nearly one-fifth of them had severe EPI. The risk factors for EPI included shock, sepsis, diabetes, cardiac arrest, hyperlactacidemia, invasive mechanical ventilation and haemodialysis.NCT01753024.
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