NCT02189993

Brief Summary

The purpose of this study is to determine what the long term survival is after in hospital use of total parenteral nutrition due to intestinal failure. Earlier studies only followed patients for a maximum of 6 months or included only very specific patients. We were interested in all patients in our hospital and followed them for up to 2 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
437

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

2.2 years

First QC Date

July 11, 2014

Last Update Submit

July 15, 2014

Conditions

Nutrition Disorders

Keywords

MortalityLong term follow-upParenteral Nutrition, Total

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Up to 1427 days

Study Arms (1)

Total Parenteral Nutrition Use

The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring total parenteral nutrition during in hospital admission.

You may qualify if:

  • all consecutive patients on TPN

You may not qualify if:

  • patients from the Pediatric and Haematological Departments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology and Hepatology, Small Bowel Unit, VU University Medical Center

Amsterdam, Netherlands

Location

Related Publications (1)

  • Oterdoom LH, Ten Dam SM, de Groot SD, Arjaans W, van Bodegraven AA. Limited long-term survival after in-hospital intestinal failure requiring total parenteral nutrition. Am J Clin Nutr. 2014 Oct;100(4):1102-7. doi: 10.3945/ajcn.114.087015. Epub 2014 Aug 13.

    PMID: 25240075DERIVED

MeSH Terms

Conditions

Nutrition DisordersHyperphagia

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leendert Oterdoom, MD PhD

    VUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Study Start

January 1, 2010

Primary Completion

April 1, 2012

Study Completion

October 1, 2013

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

NL(1)