NCT00516178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jan 2008

Typical duration for phase_3 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

3.2 years

First QC Date

August 14, 2007

Last Update Submit

February 14, 2016

Conditions

Coronary Artery Disease

Keywords

Fish oil supplementn-3 PUFACardiac functionMembrane incorporationInflammationClinical outcome

Outcome Measures

Primary Outcomes (1)

  • 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)

    48 hours

Secondary Outcomes (3)

  • Inflammatory and metabolic response

    From operation to ICU discharge (maximum 28 days)

  • Global clinical outcome

    From operation to hospital discharge (maximum 28 days)

  • Myocardial recovery after surgery

    From operation to hospital discharge (maximum 28 days)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline (No lipid emulsion)

Drug: Saline

Fish oil emulsion

EXPERIMENTAL

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

Drug: Fish oil emulsion

Interventions

Fish oil emulsionDRUG

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

Also known as: Omegaven,Fresenius Kabi AG
Fish oil emulsion
SalineDRUG

3 infusions, perioperative or post-PTCA

Placebo

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary artery disease requiring elective surgical repair under cardiopulmonary bypass
  • Acute myocardial infarction requiring ICU management

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Service of Adult Intensive Care - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 23269816RESULT

  • 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.

    PMID: 25066733DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseInflammation

Interventions

fish oil triglyceridesSodium Chloride

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mette M Berger, MD, PhD

    Serviceof Adult Intensive Care, CHUV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 15, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

CH(2)