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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition Disorders
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • University Hospital Brno and Masaryk University Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent; 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; administration of enteral nutrition
Experimental: Continuous; 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; administration of enteral nutrition

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
ICU and hospital length of stay	through study completion, an average of 3 weeks
28-day mortality	28 days from randomisation

Collaborators and Investigators

• Sponsor: Masaryk University
• Collaborators: Brno University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Ventilator Associated Pneumonia; Enteral Nutrition; Critical Care; Gastric Residual Volume
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: CT0012018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No