Intravenous Fish Oil in Critically Ill Cardiac Patients

Coronary Artery Disease Clinical Trial

— FO-cardiac  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516178
• Other study ID #: FN-3200BO-102064
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2007
• Last updated: February 14, 2016
• Start date: January 2008
• Est. completion date: April 2011

Study information

• Verified date: February 2016
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Critical Illness
• Myocardial Ischemia

Intervention

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
• Saline
3 infusions, perioperative or post-PTCA

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	VD
Switzerland	Service of Adult Intensive Care - CHUV	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Berger MM, Delodder F, Liaudet L, Tozzi P, Schlaepfer J, Chiolero RL, Tappy L. Three short perioperative infusions of n-3 PUFAs reduce systemic inflammation induced by cardiopulmonary bypass surgery: a randomized controlled trial. Am J Clin Nutr. 2013 Feb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue	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)	48 hours	No
Secondary	Inflammatory and metabolic response	cytokine determination, CRP, glucose control (blood levels and insulin requirements) in all patients	From operation to ICU discharge (maximum 28 days)	Yes
Secondary	Global clinical outcome	length of mechanical ventilation, length of ICU and hospital stay in all patients	From operation to hospital discharge (maximum 28 days)	No
Secondary	Myocardial recovery after surgery	Holter monitoring during cardiac surgery or for 72 hours	From operation to hospital discharge (maximum 28 days)	No