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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Fish oil emulsion
Saline
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Fish oil supplement, n-3 PUFA, Cardiac function, Membrane incorporation, Inflammation, Clinical outcome

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHUV
  • Service of Adult Intensive Care - CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Fish oil emulsion

Arm Description

Saline (No lipid emulsion)

3 infusions of 0.2 g/kg omega-3 PUFA within 24 hours in cardiac surgery (continuous infusion post-PTCA)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Inflammatory and metabolic response
cytokine determination, CRP, glucose control (blood levels and insulin requirements) in all patients
Global clinical outcome
length of mechanical ventilation, length of ICU and hospital stay in all patients
Myocardial recovery after surgery
Holter monitoring during cardiac surgery or for 72 hours

Full Information

First Posted
August 14, 2007
Last Updated
February 14, 2016
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT00516178
Brief Title
Intravenous Fish Oil in Critically Ill Cardiac Patients
Acronym
FO-cardiac
Official Title
Effects of Intravenous n-3 Polyunsaturated Fatty Acid Administration in Critically Ill Cardiac Surgery and Myocardial Infarction Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Fish oil supplement, n-3 PUFA, Cardiac function, Membrane incorporation, Inflammation, Clinical outcome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline (No lipid emulsion)
Arm Title
Fish oil emulsion
Arm Type
Experimental
Arm Description
3 infusions of 0.2 g/kg omega-3 PUFA within 24 hours in cardiac surgery (continuous infusion post-PTCA)
Intervention Type
Drug
Intervention Name(s)
Fish oil emulsion
Other Intervention Name(s)
Omegaven,Fresenius Kabi AG
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
3 infusions, perioperative or post-PTCA
Primary Outcome Measure Information:
Title
Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue
Description
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)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Inflammatory and metabolic response
Description
cytokine determination, CRP, glucose control (blood levels and insulin requirements) in all patients
Time Frame
From operation to ICU discharge (maximum 28 days)
Title
Global clinical outcome
Description
length of mechanical ventilation, length of ICU and hospital stay in all patients
Time Frame
From operation to hospital discharge (maximum 28 days)
Title
Myocardial recovery after surgery
Description
Holter monitoring during cardiac surgery or for 72 hours
Time Frame
From operation to hospital discharge (maximum 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette M Berger, MD, PhD
Organizational Affiliation
Serviceof Adult Intensive Care, CHUV
Official's Role
Study Director
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Service of Adult Intensive Care - CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23269816
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.
Results Reference
result
PubMed Identifier
25066733
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.
Results Reference
derived

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Intravenous Fish Oil in Critically Ill Cardiac Patients

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