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Intravenous Fish Oil in Critically Ill Cardiac Patients (FO-cardiac)

This study has been completed.
Sponsor:
Collaborator:
Fonds National Suisse de la Recherche Scientifique
Information provided by (Responsible Party):
Mette M Berger, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00516178
First received: August 14, 2007
Last updated: March 2, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
Myocardial Infarction
 Drug: Fish oil emulsion
Drug: normal saline 0.9%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Fish oil
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Changes in fatty acid cell membrane composition are likely to be the mechnism underlying other effects of omega-3 on the inflammatory and metabolic response


Secondary Outcome Measures:
  • Inflammatory and metabolic response, Clinical outcome [ Time Frame: 72 hours for lab variables, 10-15 days for clinical outcome ] [ Designated as safety issue: Yes ]
    Holter monitoring during 24 hrs (cardiac surgery) or 72 hours (MI), clinical monitroing of cardiac function, cytokine determination, glucose control, length of mechanical ventilation, length of ICU and hosptial stay


Enrollment: 31
Study Start Date: January 2008
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
No lipid emulsion - only saline
 Drug: normal saline 0.9%
3 infusions, perioperative or post-PTCA
Experimental: Fish oil
3 infusions of fish oil within 24 hours in cardiac surgery, or 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 Name: Omegaven,Fresenius Kabi AG

Detailed Description:

Randomized trial in 40 cardiac surgery patients, and 20 myocardial infarction patients Early rapid infusion of fish oil (3 times in 24 hours)in cardiac surgery patients.

Continuous infusion of the same dose over 24hrs in the myocardial infarction patients

Addenda in healthy volunteers:

  1. 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.
  2. Randomized single blind trial to prepare the next FO trial in obese: 8 different healthy obese subjects will be submitted to an LPS test (2ng/kg actual weight) to investigate their stress responses.
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516178

Locations
Switzerland
Service of Adult Intensive Care - CHUV
Lausanne, VD, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Fonds National Suisse de la Recherche Scientifique
Investigators
Study Director: Mette M Berger, MD, PhD Serviceof Adult Intensive Care, CHUV
  More Information

No publications provided by Centre Hospitalier Universitaire Vaudois

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mette M Berger, Prof, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT00516178     History of Changes
Other Study ID Numbers: FN-3200BO-102064
Study First Received: August 14, 2007
Last Updated: March 2, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Fish oil supplement
n-3 PUFA
Cardiac function
 Membrane incorporation
Inflammation
Clinical outcome

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Critical Illness
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes
Ischemia
Necrosis

ClinicalTrials.gov processed this record on May 16, 2013