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Early low-energy versus high-energy enteral nutrition support in patients with traumatic intracerebral haemorrhage: protocol for a randomised controlled trial.

ABSTRACT: Early enteral nutrition (EN) is associated with shorter hospital stay and lower infection and mortality rates in patients with intracerebral haemorrhage. However, high-energy support always causes clinical complications, such as diarrhoea and aspiration pneumonia, and the true benefit of high-energy support in these patients has not been investigated. The appropriate amount of energy support still needs further investigation. Therefore, we are performing a randomised controlled trial to investigate whether early low-energy EN can decrease mortality and feeding-related complications and improve neurological outcomes as compared with high-energy EN in traumatic intracerebral haemorrhage (TICH) patients.This is a randomised, single-blind clinical trial performed in one teaching hospital. 220 TICH patients will be randomly allocated to one of two groups in a 1:1 ratio: an intervention group, and a control group. The intervention group will receive early low-energy EN (10 kcal/kg/day) and the control group will receive high-energy EN (25 kcal/kg/day) for 7 days. All these patients will be followed up for 90 days. The primary outcome is all-cause 90-day mortality. Secondary outcomes include the modified Rankin score, Glasgow Outcome Scale (GOS) and the National Institutes of Health Stroke Scale (NIHSS). Outcomes will be assessed at admission, 7, 30 and 90 days after onset of this trial. The safety of EN strategies will be assessed every day during hospitalisation.The trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the ethics committee of Dongyang People's Hospital. The findings will be published in peer-reviewed medical journals.ChiCTR-INR-17011384; Pre-results.

SUBMITTER: Shen Y

PROVIDER: S-EPMC5719322 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Early low-energy versus high-energy enteral nutrition support in patients with traumatic intracerebral haemorrhage: protocol for a randomised controlled trial.

Shen Yanfei Y Cheng Xuping X Ying Manzhen M Zhang Weimin W Jiang Xuandong X Du Kailei K

BMJ open 20171128 11

<h4>Background</h4>Early enteral nutrition (EN) is associated with shorter hospital stay and lower infection and mortality rates in patients with intracerebral haemorrhage. However, high-energy support always causes clinical complications, such as diarrhoea and aspiration pneumonia, and the true benefit of high-energy support in these patients has not been investigated. The appropriate amount of energy support still needs further investigation. Therefore, we are performing a randomised controlle ...[more]

PMID: 29183931

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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.

Project description:ObjectiveEnteral nutrition is provided to mechanically ventilated patients who cannot eat normally, yet the amount of support needed is unknown. We conducted this randomized, open-label study to test the hypothesis that initial low-volume (i.e., trophic) enteral nutrition would decrease episodes of gastrointestinal intolerance/complications and improve outcomes as compared to initial full-energy enteral nutrition in patients with acute respiratory failure.DesignRandomized, open-label study.PatientsA total of 200 patients with acute respiratory failure expected to require mechanical ventilation for at least 72 hrs.InterventionsPatients were randomized to receive either initial trophic (10 mL/hr) or full-energy enteral nutrition for the initial 6 days of ventilation.Measurements and main resultsThe primary outcome measure was ventilator-free days to day 28. Baseline characteristics were similar between the 98 patients randomized to trophic and the 102 patients randomized to full-energy nutrition. At enrollment, patients had a mean Acute Physiology and Chronic Health Evaluation II score of 26.9 and a PaO2/FiO2 ratio of 182 and 38% were in shock. Both groups received similar durations of enteral nutrition (5.5 vs. 5.1 days; p = .51). The trophic group received an average of 15.8% ± 11% of goal calories daily through day 6 compared to 74.8% ± 38.5% (p < .001) for the full-energy group. Both groups had a median of 23.0 ventilator-free days (p = .90) and a median of 21.0 intensive-care-unit-free days (p = .64). Mortality to hospital discharge was 22.4% for the trophic group vs. 19.6% for the full-energy group (p = .62). In the first 6 days, the trophic group had trends for less diarrhea (19% vs. 24% of feeding days; p = .08) and significantly fewer episodes of elevated gastric residual volumes (2% vs. 8% of feeding days; p < .001).ConclusionInitial trophic enteral nutrition resulted in clinical outcomes in mechanically ventilated patients with acute respiratory failure similar to those of early full-energy enteral nutrition but with fewer episodes of gastrointestinal intolerance.

Project description:BackgroundRespiratory distress syndrome (RDS) and feeding intolerance are common conditions in preterm infants and among the major causes of neonatal mortality and morbidity. For many years, preterm infants with RDS have been treated with mechanical ventilation, increasing risks of acute lung injury and bronchopulmonary dysplasia. In recent years non-invasive ventilation techniques have been developed. Showing similar efficacy and risk of bronchopulmonary dysplasia, nasal continuous positive airway pressure (NCPAP) and heated humidified high-flow nasal cannula (HHHFNC) have become the most widespread techniques in neonatal intensive care units. However, their impact on nutrition, particularly on feeding tolerance and risk of complications, is still unknown in preterm infants. The aim of the study is to evaluate the impact of NCPAP vs HHHFNC on enteral feeding and to identify the most suitable technique for preterm infants with RDS.MethodsA multicenter randomized single-blind controlled trial was designed. All preterm infants with a gestational age of 25-29 weeks treated with NCPAP or HHHFNC for RDS and demonstrating stability for at least 48 h along with the compliance with inclusion criteria (age less than 7 days, need for non-invasive respiratory support, suitability to start enteral feeding) will be enrolled in the study and randomized to the NCPAP or HHHFNC arm. All patients will be monitored until discharge, and data will be analyzed according to an intention-to-treat model. The primary outcome is the time to reach full enteral feeding, while parameters of respiratory support, feeding tolerance, and overall health status will be evaluated as secondary outcomes. The sample size was calculated at 141 patients per arm.DiscussionThe identification of the most suitable technique (NCPAP vs HHHFNC) for preterm infants with feeding intolerance could reduce gastrointestinal complications, improve growth, and reduce hospital length of stay, thus improving clinical outcomes and reducing health costs. The evaluation of the timing of oral feeding could be useful in understanding the influence that these techniques could have on the development of sucking-swallow coordination. Moreover, the evaluation of the response to NCPAP and HHHFNC could clarify their efficacy as a treatment for RDS in extremely preterm infants.Trial registrationClinicalTrials.gov, NCT03548324 . Registered on 7 June 2018.

Dataset Information

Early low-energy versus high-energy enteral nutrition support in patients with traumatic intracerebral haemorrhage: protocol for a randomised controlled trial.

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Early low-energy versus high-energy enteral nutrition support in patients with traumatic intracerebral haemorrhage: protocol for a randomised controlled trial.

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