Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516178
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2007-08-14
Brief Title:
Intravenous Fish Oil in Critically Ill Cardiac Patients
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Effects of Intravenous n-3 Polyunsaturated Fatty Acid Administration in Critically Ill Cardiac Surgery and Myocardial Infarction Patients
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FO-cardiac
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 conditionsthe 3 following hypotheses will be addressed in patients requiring cardiac surgery under cardiopulmonary bypass or after myocardial infarctionperioperative post-PTCA intravenous fish oil modifies the composition of membrane phospholipids in platelets and cardiac cells blunts the physiological response to cardiac surgerymyocardial 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 06 gkg 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
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 06 gkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None