- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02189993
Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
July 15, 2014 updated by: Leendert Oterdoom, Amsterdam UMC, location VUmc
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Extensive description is not desired
Study Type
Observational
Enrollment (Actual)
437
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
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Amsterdam, Netherlands
- Department of Gastroenterology and Hepatology, Small Bowel Unit, VU University Medical Center
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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
Sampling Method
Non-Probability Sample
Study Population
Patients requiring total parenteral nutrition during in hospital admission.
Description
Inclusion Criteria:
- all consecutive patients on TPN
Exclusion Criteria:
- patients from the Pediatric and Haematological Departments
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Total Parenteral Nutrition Use
The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All cause mortality
Time Frame: Up to 1427 days
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Up to 1427 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leendert Oterdoom, MD PhD, VUMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
July 11, 2014
First Submitted That Met QC Criteria
July 14, 2014
First Posted (Estimate)
July 15, 2014
Study Record Updates
Last Update Posted (Estimate)
July 17, 2014
Last Update Submitted That Met QC Criteria
July 15, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPN-01
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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