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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Major Liver Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Omegaven™

Intervention Type DRUG

NaCl 0.9%

100ml of saline is used as a placebo comparator and administered as described above.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Omegaven™

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No