NCT03573453

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 25, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

4.5 years

First QC Date

April 17, 2018

Last Update Submit

March 27, 2023

Conditions

Nutrition Disorders

Keywords

Critical CareEnteral NutritionVentilator Associated PneumoniaGastric Residual Volume

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Protein target

    5 days from initiation of enteral nutrition

  • Tolerance of enteral nutrition

    5 days from initiation of enteral nutrition

  • Tolerance of enteral nutrition

    5 days from initiation of enteral nutrition

  • Tolerance of enteral nutrition

    5 days from initiation of enteral nutrition

  • Complications of enteral nutrition

    5 days from initiation of enteral nutrition

  • +3 more secondary outcomes

Other Outcomes (2)

  • ICU and hospital length of stay

    through study completion, an average of 3 weeks

  • 28-day mortality

    28 days from randomisation

Study Arms (2)

Intermittent

EXPERIMENTAL

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

Continuous

EXPERIMENTAL

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

Interventions

enteral nutritionOTHER

administration of enteral nutrition

ContinuousIntermittent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brno and Masaryk University Brno

Brno, 62500, Czechia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33228772DERIVED

MeSH Terms

Conditions

Nutrition DisordersPneumonia, Ventilator-Associated

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesHealthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Roman Gal, prof MD PhD

    Masaryk University Brno

    STUDY CHAIR

Central Study Contacts

Ondrej Hrdy, MD

CONTACT

+420 532 232 305Hrdy.Ondrej@fnbrno.cz

Robert Vach, MD

CONTACT

+420 532 233 850Vach.Robert@fnbrno.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

June 29, 2018

Study Start

November 25, 2018

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)