Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver... | NCT02319252

Studies
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

NCT02319252

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Apr 20, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Malnutrition
Liver Diseases, Alcoholic

Interventions

Gastric tube (Nutricia Flocare® Pur Tube Enlock)
Jejunal tube (Nutricia Flocare® Bengmark®)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Dec 2, 2014

First Submission Date that Met QC Criteria

Dec 12, 2014

First Posted Date

Dec 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2018

Last Update Posted Date

Apr 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Gastric tube (Nutricia Flocare® Pur Tube Enlock)	Device	Nutricia Flocare® Pur Tube Enlock, Ch. 12	Gastric tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Palle Bager, PhD	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus	Central Region	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D008108	Liver Diseases, Alcoholic

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided