NCT02319252

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 20, 2018

Status Verified

May 1, 2016

Enrollment Period

3.2 years

First QC Date

December 2, 2014

Last Update Submit

April 18, 2018

Conditions

MalnutritionLiver Diseases, Alcoholic

Outcome Measures

Primary Outcomes (1)

  • Differences in nutrition intake

    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 Outcomes (1)

  • Differences in patients reported outcomes

    Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months

Study Arms (2)

Gastric tube

ACTIVE COMPARATOR

A gastric tube is used

Device: Gastric tube (Nutricia Flocare® Pur Tube Enlock)

Jejunal tube

ACTIVE COMPARATOR

A jejunal tube is used

Device: Jejunal tube (Nutricia Flocare® Bengmark®)

Interventions

Gastric tube (Nutricia Flocare® Pur Tube Enlock)DEVICE

Nutricia Flocare® Pur Tube Enlock, Ch. 12

Gastric tube
Jejunal tube (Nutricia Flocare® Bengmark®)DEVICE

Nutricia Flocare® Bengmark®, Ch. 10

Jejunal tube

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Region, 8000, Denmark

Location

MeSH Terms

Conditions

MalnutritionLiver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesLiver DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Palle Bager, PhD

    Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

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

December 2, 2014

First Posted

December 18, 2014

Study Start

January 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 20, 2018

Record last verified: 2016-05

Locations

DK(1)