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Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189993
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
Leendert Oterdoom, VU University Medical Center

Tracking Information
First Submitted Date July 11, 2014
First Posted Date July 15, 2014
Last Update Posted Date July 17, 2014
Study Start Date January 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2014)
All cause mortality [ Time Frame: Up to 1427 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
Official Title Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
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.

Detailed Description Extensive description is not desired
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients requiring total parenteral nutrition during in hospital admission.
Condition Nutrition Disorders
Intervention Not Provided
Study Groups/Cohorts Total Parenteral Nutrition Use
The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 14, 2014)
437
Original Actual Enrollment Same as current
Actual Study Completion Date October 2013
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all consecutive patients on TPN

Exclusion Criteria:

  • patients from the Pediatric and Haematological Departments
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02189993
Other Study ID Numbers TPN-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Leendert Oterdoom, VU University Medical Center
Study Sponsor VU University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Leendert Oterdoom, MD PhD VUMC
PRS Account VU University Medical Center
Verification Date July 2014