Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Nutrition Disorders

Intervention / Treatment
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* Other: enteral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent<br>enteral nutrition will be administered via enteral feeding pump as 30-60minutes lasting bolus 6 times per day volume of initial bolus will be 80ml. The volume of bolus will be increased gradually according to tolerance, till the estimated target rate will be reached | Other: enteral nutrition<br>* administration of enteral nutrition<br>|
| Experimental: Continuous<br>enteral nutrition will be administered via enteral feeding pump for at least 16 hours par day initial rate will be 25ml/hour. The rate will be increased gradually according to tolerance, till the estimated target rate will be reached | Other: enteral nutrition<br>* administration of enteral nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy target | Daily assessment of energy intake in critically ill patients with enteral nutrition.Energy target will be achieved if at least 80% of calculated energy intake will be delivered. | 5 days from initiation of enteral nutrition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein target | Daily assessment of protein intake in critically ill patients with enteral nutrition.Protein target will be achieved if at least 80% of calculated protein intake will be delivered. | 5 days from initiation of enteral nutrition | 
| Tolerance of enteral nutrition | Measurement of the gastric residual volume | 5 days from initiation of enteral nutrition | 
| Tolerance of enteral nutrition | Incidence of diarrhoea | 5 days from initiation of enteral nutrition | 
| Tolerance of enteral nutrition | Incidence of vomiting | 5 days from initiation of enteral nutrition | 
| Complications of enteral nutrition | Incidence of aspiration and ventilator associated pneumonia | 5 days from initiation of enteral nutrition | 
| Nutritional status | Blood test : total serum protein test | On admission and day 5 from initiation of enteral nutrition | 
| Nutritional status | Blood test : albumin test | On admission and day 5 from initiation of enteral nutrition | 
| Nutritional status | Blood test : prealbumin test | On admission and day 5 from initiation of enteral nutrition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Care, Enteral Nutrition, Ventilator Associated Pneumonia, Gastric Residual Volume