Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection

• Sponsor: University of Zurich (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01884948
• Collaborator: (none)
• Enrollment: 258
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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).

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2013
• Anticipated Primary Completion Date: Mar 1, 2016
• Anticipated Study Completion Date: Mar 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Postoperative complications [1 month after hospital discharge]

   Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Visceral and Transplantation Surgery	Zurich	ZH	Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

• Principal Investigator: Pierre Alain Clavien, MD PhD, University Hospital Zurich, Visceral and Transplantation Surgery

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Omegaven

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT01884948
• Other Study ID Numbers: Omegaven - Zurich
• First Posted: Jun 24, 2013
• Last Update Posted: Jun 4, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by University of Zurich: at least 1 segment; multiple wedge resections (≥3)

Study Results

No Results Posted as of Jun 4, 2014