FO-cardiac: Intravenous Fish Oil in Critically Ill Cardiac Patients

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Completed

CT.gov ID

NCT00516178

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

15.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Fish oil emulsion Drug: Saline	Phase 3

Detailed Description

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

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effects of Intravenous n-3 Polyunsaturated Fatty Acid Administration in Critically Ill Cardiac Surgery and Myocardial Infarction Patients

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Saline (No lipid emulsion)	Drug: Saline 3 infusions, perioperative or post-PTCA
Experimental: Fish oil emulsion 3 infusions of 0.2 g/kg omega-3 PUFA within 24 hours in cardiac surgery (continuous infusion post-PTCA)	Drug: 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 Other Names: Omegaven,Fresenius Kabi AG

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Saline (No lipid emulsion)

Drug: Saline

3 infusions, perioperative or post-PTCA

Experimental: Fish oil emulsion

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

Drug: 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

Other Names:

Omegaven,Fresenius Kabi AG

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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