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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette M Berger, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00516178
First received: August 14, 2007
Last updated: February 14, 2016
Last verified: February 2016
  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
Drug: Fish oil emulsion
Drug: Saline
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:


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 ]
    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 [ Time Frame: From operation to ICU discharge (maximum 28 days) ] [ Designated as safety issue: Yes ]
    cytokine determination, CRP, glucose control (blood levels and insulin requirements) in all patients

  • Global clinical outcome [ Time Frame: From operation to hospital discharge (maximum 28 days) ] [ Designated as safety issue: No ]
    length of mechanical ventilation, length of ICU and hospital stay in all patients

  • Myocardial recovery after surgery [ Time Frame: From operation to hospital discharge (maximum 28 days) ] [ Designated as safety issue: No ]
    Holter monitoring during cardiac surgery or for 72 hours


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
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 Name: Omegaven,Fresenius Kabi AG

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

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516178

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

Publications:
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: February 14, 2016
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
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2016