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

Primary Purpose

Nutrition Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
enteral nutrition
Sponsored by
Masaryk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutrition Disorders focused on measuring Critical Care, Enteral Nutrition, Ventilator Associated Pneumonia, Gastric Residual Volume

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Brno and Masaryk University BrnoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intermittent

Continuous

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Tolerance of enteral nutrition
Measurement of the gastric residual volume
Tolerance of enteral nutrition
Incidence of diarrhoea
Tolerance of enteral nutrition
Incidence of vomiting
Complications of enteral nutrition
Incidence of aspiration and ventilator associated pneumonia
Nutritional status
Blood test : total serum protein test
Nutritional status
Blood test : albumin test
Nutritional status
Blood test : prealbumin test

Full Information

First Posted
April 17, 2018
Last Updated
March 27, 2023
Sponsor
Masaryk University
Collaborators
Brno University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03573453
Brief Title
Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients.
Acronym
COINN
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2018 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masaryk University
Collaborators
Brno University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders
Keywords
Critical Care, Enteral Nutrition, Ventilator Associated Pneumonia, Gastric Residual Volume

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent
Arm Type
Experimental
Arm Description
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
Arm Title
Continuous
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
enteral nutrition
Intervention Description
administration of enteral nutrition
Primary Outcome Measure Information:
Title
Energy target
Description
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.
Time Frame
5 days from initiation of enteral nutrition
Secondary Outcome Measure Information:
Title
Protein target
Description
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.
Time Frame
5 days from initiation of enteral nutrition
Title
Tolerance of enteral nutrition
Description
Measurement of the gastric residual volume
Time Frame
5 days from initiation of enteral nutrition
Title
Tolerance of enteral nutrition
Description
Incidence of diarrhoea
Time Frame
5 days from initiation of enteral nutrition
Title
Tolerance of enteral nutrition
Description
Incidence of vomiting
Time Frame
5 days from initiation of enteral nutrition
Title
Complications of enteral nutrition
Description
Incidence of aspiration and ventilator associated pneumonia
Time Frame
5 days from initiation of enteral nutrition
Title
Nutritional status
Description
Blood test : total serum protein test
Time Frame
On admission and day 5 from initiation of enteral nutrition
Title
Nutritional status
Description
Blood test : albumin test
Time Frame
On admission and day 5 from initiation of enteral nutrition
Title
Nutritional status
Description
Blood test : prealbumin test
Time Frame
On admission and day 5 from initiation of enteral nutrition
Other Pre-specified Outcome Measures:
Title
ICU and hospital length of stay
Time Frame
through study completion, an average of 3 weeks
Title
28-day mortality
Time Frame
28 days from randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ondrej Hrdy, MD
Phone
+420 532 232 305
Email
Hrdy.Ondrej@fnbrno.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Vach, MD
Phone
+420 532 233 850
Email
Vach.Robert@fnbrno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Gal, prof MD PhD
Organizational Affiliation
Masaryk University Brno
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Brno and Masaryk University Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ondrej Hrdy, M.D.
Phone
+420532232305
Email
hrdy.ondrej@fnbrno.cz
First Name & Middle Initial & Last Name & Degree
Petr Suk, M.D.
Phone
+420532232305
Email
suk.petr@fnbrno.cz

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33228772
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.
Results Reference
derived

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

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