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Completed

NCT Number: NCT00516178

Intravenous Fish Oil in Critically Ill Cardiac Patients

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHUV, Lausanne, Canton of Vaud, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish oil emulsion

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

Other names: Omegaven,Fresenius Kabi AG

Saline

Drug

3 infusions, perioperative or post-PTCA

Primary outcomes

  1. Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue

    Time frame: 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 outcomes

  1. Inflammatory and metabolic response

    Time frame: From operation to ICU discharge (maximum 28 days)

    cytokine determination, CRP, glucose control (blood levels and insulin requirements) in all patients

  2. Global clinical outcome

    Time frame: From operation to hospital discharge (maximum 28 days)

    length of mechanical ventilation, length of ICU and hospital stay in all patients

  3. Myocardial recovery after surgery

    Time frame: From operation to hospital discharge (maximum 28 days)

    Holter monitoring during cardiac surgery or for 72 hours

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: FO-cardiac

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 15, 2007
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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