Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

April 18, 2018 updated by: University of Aarhus

The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal feeding tubes are the most effect full to feed patients with alcoholic liver diseases and non-sufficient oral intake.

The primary outcome will be differences in nutrition intake between the groups. Secondary outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients' quality of life, nausea & vomiting.

The study will include 40 patients at Aarhus University Hospital, Denmark.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Region
      • Aarhus, Central Region, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Alcoholic liver disease
  • nutrition intake less than 75% of needed intake
  • Signed informed consent form

Exclusion Criteria:

  • Hepatic encephalopathy, grade 3 - 4
  • Anatomic barriers to have a tube placed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gastric tube
A gastric tube is used
Device: Gastric tube (Nutricia Flocare® Pur Tube Enlock)
Nutricia Flocare® Pur Tube Enlock, Ch. 12
Active Comparator: Jejunal tube
A jejunal tube is used
Device: Jejunal tube (Nutricia Flocare® Bengmark®)
Nutricia Flocare® Bengmark®, Ch. 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in nutrition intake
Time Frame: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
Nutrition intake, protein intake, oral intake versus tube intake
Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in patients reported outcomes
Time Frame: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
Questionnaires
Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Palle Bager, PhD, Aarhus University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tubes in liver diseases

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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