Intravenous Fish Oil in Critically Ill Cardiac Patients

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-04-30

Brief Summary

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A large body of evidence has accumulated showing that n-3 PUFAs exert extensive cardiac effects. The development of commercial solutions of FO opens perspectives for therapeutic applications in patients with acute cardiac conditions.the 3 following hypotheses will be addressed in patients requiring cardiac surgery under cardiopulmonary bypass or after myocardial infarction:perioperative /post-PTCA intravenous fish oil modifies the composition of membrane phospholipids in platelets and cardiac cells, blunts the physiological response to cardiac surgery/myocardial infarction, and reduces the incidence of arrhythmias, and reduces the occurrence of systolic dysfunction.

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Detailed Description

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A. Randomized trial in 40 cardiac surgery patients Early rapid infusion of fish oil (3 times in 24 hours) in cardiac surgery patients.

B. Randomized trial 20 myocardial infarction patients (abandonned) Continuous infusion of the same dose over 24hrs in the myocardial infarction patients

Additional trial in healthy volunteers (investigating physiological changes after cardiac study):

-Open trial in 8 healthy lean volunteers to investigate the impact of the same 0.6 g/kg FO dose IV (Week 1: 3hrs), and then orally on week 2, on platelet n-3 PUFA incorporation, platelet function, heart rate and peak flow response to stress test.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Saline (No lipid emulsion)

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

3 infusions, perioperative or post-PTCA

Fish oil emulsion

3 infusions of 0.2 g/kg omega-3 PUFA within 24 hours in cardiac surgery (continuous infusion post-PTCA)

Group Type EXPERIMENTAL

Fish oil emulsion

Intervention Type DRUG

0.2 g/kg FO, 3 times in 24 hours, infused over 3 hours each in cardiac surgery, or continuous infusion of 0.6 g/kg post PTCA

Interventions

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Fish oil emulsion

0.2 g/kg FO, 3 times in 24 hours, infused over 3 hours each in cardiac surgery, or continuous infusion of 0.6 g/kg post PTCA

Intervention Type DRUG

Saline

3 infusions, perioperative or post-PTCA

Intervention Type DRUG

Other Intervention Names

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Omegaven,Fresenius Kabi AG

Eligibility Criteria

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Inclusion Criteria

* Coronary artery disease requiring elective surgical repair under cardiopulmonary bypass
* Acute myocardial infarction requiring ICU management

Exclusion Criteria

* Absence of consent
* Ventricular ejection fraction \< 35%
* Beating heart surgery or emergency surgery
* Hypercholesterolemia \> 5 mmol/l
* Thrombolysis
* Chronic steroid therapy
* Acute or chronic renal failure prior to surgery (plasma creatinine \> 150 umol/l)
* Chronic coagulation disorder
* Premenopausal female
* Consumption of more than 3 times fish per week

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes