Clinical trial NCT03573453: Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients.
Official title: Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients. Effect on Energy and Protein Target Achievement, Tolerance and Incidence of Complications. Monocentric Prospective Randomised Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition Disorders
Keywords: Critical Care
Enteral Nutrition
Ventilator Associated Pneumonia
Gastric Residual Volume
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
First posted: 2018-06-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition.

Detailed description: The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of June 2018 to the 31st of May 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Enteral nutrition will be administered via nasogastric of orogastric tube. Patients will be randomised in 2 groups. In the group of patients receiving continuous feeding will be enteral nutrition administered via enteral feeding pump for at least 16 hours par day. In the group of patients receiving intermittent feeding will be enteral nutrition administered as 30-60minutes lasting bolus via enteral feeding pump 6 times per day. Following the administration of the bolus the patient will be placed for 30 minutes in semi-upright sitting position. Enteral nutrition requirement and composition will be standardised with the adoption of international guidelines. In 5 subsequent days from the enteral nutrition commencement will be examined if there is a difference in achieving energy and protein targets, tolerance and number of complications of enteral nutrition in between both groups. As achievement of energy and protein targets will be considered at least 80% of calculated values. The tolerance of enteral nutrition will be evaluated by the clinical examination of the abdomen, presence of diarrhoea, vomiting and the gastric residual volume of at least 0,5 liter. As the complications of enteral nutrition will be regarded the aspiration of gastric contents and ventilator associated pneumonia. Nutritional status parameters will be analysed. the length of hospital stay, ICU length of stay and 28-day mortality will be also monitored.

Eligibility criteria: Inclusion Criteria:

* age between 18 - 80 years
* indication of enteral nutrition with nasogastric or orogastric tube
* Nutrition Risk in the Critically Ill (NUTRIC) score ≥5
* Body mass index between 18 - 50
* mechanical ventilation expected for at least 72 hours

Exclusion Criteria:

* upper gastrointestinal tract surgery in previous medical history
* bowel obstruction
* bowel ischemia
* acute pancreatitis
* severe diarrhoea (\>1l/24hours)
* gastrointestinal bleeding
* short bowel syndrome
* malabsorption syndrome in previous medical history
* ongoing enteral nutrition on admission to ICU

Primary outcomes:
measure: Energy target
timeFrame: 5 days from initiation of enteral nutrition
Secondary outcomes:
measure: Protein target
timeFrame: 5 days from initiation of enteral nutrition
measure: Tolerance of enteral nutrition
timeFrame: 5 days from initiation of enteral nutrition
measure: Tolerance of enteral nutrition
timeFrame: 5 days from initiation of enteral nutrition
measure: Tolerance of enteral nutrition
timeFrame: 5 days from initiation of enteral nutrition
measure: Complications of enteral nutrition
timeFrame: 5 days from initiation of enteral nutrition
measure: Nutritional status
timeFrame: On admission and day 5 from initiation of enteral nutrition
measure: Nutritional status
timeFrame: On admission and day 5 from initiation of enteral nutrition
measure: Nutritional status
timeFrame: On admission and day 5 from initiation of enteral nutrition
Other outcomes:
measure: ICU and hospital length of stay
timeFrame: through study completion, an average of 3 weeks
measure: 28-day mortality
timeFrame: 28 days from randomisation
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno and Masaryk University Brno
Study officials:
affiliation: Masaryk University Brno
name: Roman Gal, prof MD PhD
role: STUDY_CHAIR
References:
citation: Hrdy O, Vrbica K, Strazevska E, Suk P, Souckova L, Stepanova R, Sas I, Gal R. Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial. Trials. 2020 Nov 23;21(1):955. doi: 10.1186/s13063-020-04866-2.