Intravenous Fish Oil in Critically Ill Cardiac Patients

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Saline; Drug: Fish oil emulsion

• Registration Number: NCT00516178
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-15
• Study Start: 2008-01
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-14
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline (No lipid emulsion)
Fish oil emulsion	Fish oil emulsion	3 infusions of 0.2 g/kg omega-3 PUFA within 24 hours in cardiac surgery (continuous infusion post-PTCA)

Primary Outcome Measures

Name	Time	Method
Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue	48 hours	The primary outcome is the determination of magnitude of the incorporation and the time required for incorporation of omega-3 fatty acid cell membrane composition after short intravenous infusions was unknown until the present study (HPLC determination of fatty acid membrane composition in all patients)

Secondary Outcome Measures

Name	Time	Method
Inflammatory and metabolic response	From operation to ICU discharge (maximum 28 days)	cytokine determination, CRP, glucose control (blood levels and insulin requirements) in all patients
Global clinical outcome	From operation to hospital discharge (maximum 28 days)	length of mechanical ventilation, length of ICU and hospital stay in all patients
Myocardial recovery after surgery	From operation to hospital discharge (maximum 28 days)	Holter monitoring during cardiac surgery or for 72 hours

Trial Locations

Locations (2)

CHUV; 🇨🇭 Lausanne, VD, Switzerland

Service of Adult Intensive Care - CHUV; 🇨🇭 Lausanne, VD, Switzerland