|- candidate number||25608|
|- NTR Number||NTR6997|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-nov-2016|
|- Secondary IDs|| |
|- Public Title||Clinical outcomes of patients with severe intestinal failure on intravenous nutrition at home.|
|- Scientific Title||Clinical outcomes of patients with severe intestinal failure on olive-oil-based home parenteral nutrition.|
|- hypothesis||To 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) studied||Severe 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 criteria||HPN frequency <3 times per week.|
Solely intravenous fluids depended patients.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jan-2017|
|- planned closingdate||31-dec-2017|
|- Target number of participants||0|
|- Interventions||Olive-oil-based home parenteral nutrition.|
|- Primary outcome||1. Patient survival. |
|- Secondary outcome||1. 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).
|- Timepoints||1 year study. Half year inclusion of patients from retrospective data in a database. Half year statistics and dissemination of results.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Yannick Wouters|
|- CONTACT for SCIENTIFIC QUERIES|| Yannick Wouters|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary||Observational 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.|
|- RECORD||28-nov-2016 - 8-feb-2018|