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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
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing postoperative morbidity and mortality after major liver resection.

Condition or disease Intervention/treatment Phase
Major Liver Surgery Drug: Omegaven™ Phase 3

Detailed Description:
With two single doses of Omegaven (pre- and postoperatively) we aim to reduce postoperative complications measured by the CCI (Comprehensive Complication Index) and the Clavien Dindo classification of surgical complications. The study will include adults (more than 18 years) patients requiring liver resection of at least 1 segment or multiple wedge resections (≥3).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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).
Drug: Omegaven™
Placebo Comparator: NaCl 0.9%
100ml of saline is used as a placebo comparator and administered as described above.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Requiring liver resection of at least 1 segment or multiple wedge resections (=3)
  • > 18 years of age
  • No coagulopathy (INR < 1.2, platelets >150'000 x10E3/µl)
  • Understands local language

Exclusion criteria:

  • Liver resections <1 segment
  • Wedge resections (<3)
  • Liver cirrhosis
  • Coagulopathy (INR > 1.2, platelets < 150'000 x10E3/µl)
  • Hypertriglyceridemia (> 5.0 mmol/l)
  • Hypersensitivity or allergy to Omegaven™ or any fish oil or lipid emulsions
  • Known allergy to egg protein
  • Pregnancy
  • Nursing women
  • Renal failure(estimated GFR < 30 ml/min/1.73m2)
  • Medication impairing platelets aggregation
  • Cannot understand local language

Information from the National Library of Medicine

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


Contacts
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Contact: Michael Linecker, MD 0041 442553300 Michael.Linecker@usz.ch
Contact: Pierre Alain Clavien, MD PhD 0041 442553300 clavien@access.uzh.ch

Locations
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Switzerland
University Hospital Zurich, Visceral and Transplantation Surgery Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Pierre Alain Clavien, MD PhD University Hospital Zurich, Visceral and Transplantation Surgery
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01884948    
Other Study ID Numbers: Omegaven - Zurich
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014
Keywords provided by University of Zurich:
at least 1 segment
multiple wedge resections (≥3)