Clinical trial NCT00516178: Intravenous Fish Oil in Critically Ill Cardiac Patients
Official title: Effects of Intravenous n-3 Polyunsaturated Fatty Acid Administration in Critically Ill Cardiac Surgery and Myocardial Infarction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Fish oil supplement
n-3 PUFA
Cardiac function
Membrane incorporation
Inflammation
Clinical outcome
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2007-08-15
Enrollment: 31
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue
timeFrame: 48 hours
Secondary outcomes:
measure: Inflammatory and metabolic response
timeFrame: From operation to ICU discharge (maximum 28 days)
measure: Global clinical outcome
timeFrame: From operation to hospital discharge (maximum 28 days)
measure: Myocardial recovery after surgery
timeFrame: From operation to hospital discharge (maximum 28 days)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: VD
city: Lausanne
country: Switzerland
facility: Service of Adult Intensive Care - CHUV
state: VD
Study officials:
affiliation: Serviceof Adult Intensive Care, CHUV
name: Mette M Berger, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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;97(2):246-54. doi: 10.3945/ajcn.112.046573. Epub 2012 Dec 26.
citation: Delodder F, Tappy L, Liaudet L, Schneiter P, Perrudet C, Berger MM. Incorporation and washout of n-3 PUFA after high dose intravenous and oral supplementation in healthy volunteers. Clin Nutr. 2015 Jun;34(3):400-8. doi: 10.1016/j.clnu.2014.07.005. Epub 2014 Jul 15.