Nutrition DisordersNCT02189993
Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
An observational study of Nutrition Disorders, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Disorders
- How many people
- 437 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring total parenteral nutrition during in hospital admission.
Who may be able to join
- all consecutive patients on TPN
Who cannot join
- patients from the Pediatric and Haematological Departments
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Gastroenterology and Hepatology, Small Bowel Unit, VU University Medical Center
Amsterdam
About this study
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.
Read the detailed description
Extensive description is not desired
- Conditions
- Nutrition Disorders
- Keywords
- Mortality, Long term follow-up, Parenteral Nutrition, Total
- Medical subject headings
- Nutrition Disorders, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Parenteral Nutrition Use | The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: Up to 1427 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leendert Oterdoom, Amsterdam UMC, location VUmc
- Investigators
- Leendert Oterdoom, MD PhD, Principal investigator, VUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189993
- Sponsor's protocol ID
- TPN-01
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2014
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25240075
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT02189993
- Acronym / sponsor ID
- TPN-01
- Conditions
- Nutrition Disorders
- Keywords
- Mortality, Long term follow-up, Parenteral Nutrition, Total
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Parenteral Nutrition Use | – | –The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring total parenteral nutrition during in hospital admission.
Key inclusion criteria (1 listed)
- all consecutive patients on TPN
Key exclusion criteria (1 listed)
- patients from the Pediatric and Haematological Departments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: Up to 1427 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Derived from this study: PubMed 25240075Oterdoom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leendert Oterdoom, MD PhD principal investigator
VUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorders, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Up to 1427 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02189993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.