Coronary Artery DiseasePhase 3FO-cardiacNCT00516178
Intravenous Fish Oil in Critically Ill Cardiac Patients
A Phase 3 study testing Fish oil emulsion and Saline in people with Coronary Artery Disease, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Fish oil emulsion and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2008to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coronary artery disease requiring elective surgical repair under cardiopulmonary bypass
- Acute myocardial infarction requiring ICU management
Who cannot join
- Absence of consent
- Ventricular ejection fraction < 35%
- Beating heart surgery or emergency surgery
- Hypercholesterolemia > 5 mmol/l
- Thrombolysis
- Chronic steroid therapy
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
CHUV
Lausanne, Canton of Vaud, 1011
Service of Adult Intensive Care - CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official title: Effects of Intravenous n-3 Polyunsaturated Fatty Acid Administration in Critically Ill Cardiac Surgery and Myocardial Infarction 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.
Read the detailed description
- Randomized trial in 40 cardiac surgery patients Early rapid infusion of fish oil (3 times in 24 hours) in cardiac surgery patients.
- 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Fish oil emulsion, Saline
- Keywords
- Fish oil supplement, n-3 PUFA, Cardiac function, Membrane incorporation, Inflammation, Clinical outcome
- Medical subject headings
- Coronary Artery Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil emulsionDrug
Also called Omegaven,Fresenius Kabi AG
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
SalineDrug
3 infusions, perioperative or post-PTCA
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline (No lipid emulsion) Receives: 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) Receives: Drug: Fish oil emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 hours
Secondary outcomes (3)
Inflammatory and metabolic response
cytokine determination, CRP, glucose control (blood levels and insulin requirements) in all patients
Measured: From operation to ICU discharge (maximum 28 days)
Global clinical outcome
length of mechanical ventilation, length of ICU and hospital stay in all patients
Measured: From operation to hospital discharge (maximum 28 days)
Myocardial recovery after surgery
Holter monitoring during cardiac surgery or for 72 hours
Measured: From operation to hospital discharge (maximum 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJan 2008
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette M Berger, Centre Hospitalier Universitaire Vaudois
- Investigators
- Mette M Berger, MD, PhD, Study director, Serviceof Adult Intensive Care, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516178
- Sponsor's protocol ID
- FN-3200BO-102064
- Acronym
- FO-cardiac
- Status last verified
- Feb 2016
- First submitted
- 14 Aug 2007
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23269816Delodder 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.
PubMed 25066733
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous n-3 Polyunsaturated Fatty Acid Administration in Critically Ill Cardiac Surgery and Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT00516178
- Acronym / sponsor ID
- FO-cardiac / FN-3200BO-102064
- Conditions
- Coronary Artery Disease
- Keywords
- Fish oil supplement, n-3 PUFA, Cardiac function, Membrane incorporation, Inflammation, Clinical outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Randomized trial in 40 cardiac surgery patients Early rapid infusion of fish oil (3 times in 24 hours) in cardiac surgery patients.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineSaline (No lipid emulsion) |
| Fish oil emulsion | Experimental | Drug: Fish oil emulsion3 infusions of 0.2 g/kg omega-3 PUFA within 24 hours in cardiac surgery (continuous infusion post-PTCA) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary artery disease requiring elective surgical repair under cardiopulmonary bypass
- Acute myocardial infarction requiring ICU management
Key exclusion criteria (10 listed)
- Absence of consent
- Ventricular ejection fraction < 35%
- Beating heart surgery or emergency surgery
- Hypercholesterolemia > 5 mmol/l
- Thrombolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil emulsionAlso: Omegaven,Fresenius Kabi AG0.2 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 | Drug | Fish oil emulsion |
| Saline3 infusions, perioperative or post-PTCA | Drug | Placebo |
Primary outcome
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)
3 secondary outcomes
Inflammatory and metabolic response
Time frame: From operation to ICU discharge (maximum 28 days)
Global clinical outcome
Time frame: From operation to hospital discharge (maximum 28 days)
Myocardial recovery after surgery
Time frame: From operation to hospital discharge (maximum 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Results publication: PubMed 23269816Berger 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.
- Derived from this study: PubMed 25066733Delodder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette M Berger, MD, PhD study director
Serviceof Adult Intensive Care, CHUV
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fish oil emulsion and Saline in people with Coronary Artery Disease, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00516178, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.