Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection
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|ClinicalTrials.gov Identifier: NCT01884948|
Recruitment Status : Unknown
Verified June 2014 by University of Zurich.
Recruitment status was: Recruiting
First Posted : June 24, 2013
Last Update Posted : June 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Major Liver Surgery||Drug: Omegaven™||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||258 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind Study of the Effects of Omega-3 Fatty Acids (Omegaven™) on Outcome After Major Liver Resection|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
Active Comparator: Omegaven™
Omegaven™ (approval number:54750 Swissmedic)- 100ml intravenously. The first dose (Omegaven™ or placebo) is administered in the evening before surgery, the second dose at the beginning of anesthesia. The maximum infusion rate must be adjusted to bodyweight (0.5 ml Omegaven™/kg/hour).
Placebo Comparator: NaCl 0.9%
100ml of saline is used as a placebo comparator and administered as described above.
- Postoperative complications [ Time Frame: 1 month after hospital discharge ]Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884948
|Contact: Michael Linecker, MD||0041 442553300||Michael.Linecker@usz.ch|
|Contact: Pierre Alain Clavien, MD PhD||0041 firstname.lastname@example.org|
|University Hospital Zurich, Visceral and Transplantation Surgery||Recruiting|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Pierre Alain Clavien, MD PhD||University Hospital Zurich, Visceral and Transplantation Surgery|