search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Clinical outcomes of patients with severe intestinal failure on intravenous nutrition at home.


- candidate number25608
- NTR NumberNTR6997
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-nov-2016
- Secondary IDs 
- Public TitleClinical outcomes of patients with severe intestinal failure on intravenous nutrition at home.
- Scientific TitleClinical outcomes of patients with severe intestinal failure on olive-oil-based home parenteral nutrition.
- ACRONYM
- hypothesisTo highlight the efficacy and safety of long-term use of olive-oil-based home parenteral nutrition in patients with severe intestinal failure
- Healt Condition(s) or Problem(s) studiedSevere intestinal failure, Home parenteral nutrition (HPN), Olive-oil-based
- Inclusion criteria- HPN patients with olive-oil-based HPN for at least 3 months for at least 70% of the time.
- Patients >18 years.
- Exclusion criteriaHPN frequency <3 times per week.
Solely intravenous fluids depended patients.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2017
- planned closingdate31-dec-2017
- Target number of participants0
- InterventionsOlive-oil-based home parenteral nutrition.
- Primary outcome1. Patient survival.
- Secondary outcome1. Relevant adverse events:
- Early: hypersensitivity to lipid emulsion components
- Delayed: bone disease.
2. Serious adverse events (Life threatening events and Hospital admissions).
3. Discontinuation of HPN and reason.
4. Catheter-related bloodstream infections (incidende rate).
5. Catheter-related occlusions (incidende rate).
6. Need for intestinal transplantation (Incidence and cause).
- Timepoints1 year study. Half year inclusion of patients from retrospective data in a database. Half year statistics and dissemination of results.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Yannick Wouters
- CONTACT for SCIENTIFIC QUERIES Yannick Wouters
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Baxter
- Publications
- Brief summaryObservational study highlighting the efficacy and safety of long-term use of olive-oil-based home parenteral nutrition in patients with severe intestinal failure in a single center (Radboudumc).
- Main changes (audit trail)Ontbrekende informatie niet aangeleverd door onderzoeker.
- RECORD28-nov-2016 - 8-feb-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl