Back to resultsGastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases
Primary Purpose
Malnutrition, Liver Diseases, Alcoholic
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Gastric tube (Nutricia Flocare® Pur Tube Enlock)
Jejunal tube (Nutricia Flocare® Bengmark®)
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition
Eligibility Criteria
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
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gastric tube
Jejunal tube
Arm Description
A gastric tube is used
A jejunal tube is used
Outcomes
Primary Outcome Measures
Differences in nutrition intake
Nutrition intake, protein intake, oral intake versus tube intake
Secondary Outcome Measures
Differences in patients reported outcomes
Questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02319252
Brief Title
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases
Official Title
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Liver Diseases, Alcoholic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gastric tube
Arm Type
Active Comparator
Arm Description
A gastric tube is used
Arm Title
Jejunal tube
Arm Type
Active Comparator
Arm Description
A jejunal tube is used
Intervention Type
Device
Intervention Name(s)
Gastric tube (Nutricia Flocare® Pur Tube Enlock)
Intervention Description
Nutricia Flocare® Pur Tube Enlock, Ch. 12
Intervention Type
Device
Intervention Name(s)
Jejunal tube (Nutricia Flocare® Bengmark®)
Intervention Description
Nutricia Flocare® Bengmark®, Ch. 10
Primary Outcome Measure Information:
Title
Differences in nutrition intake
Description
Nutrition intake, protein intake, oral intake versus tube intake
Time Frame
Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
Secondary Outcome Measure Information:
Title
Differences in patients reported outcomes
Description
Questionnaires
Time Frame
Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Palle Bager, PhD
Organizational Affiliation
Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Central Region
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases
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