Ignite Creation Date:
2024-05-05 @ 10:58 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01225094
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2010-10-19
Brief Title:
Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm AAA Repair
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Curcumin to Prevent Perioperative Complications After Elective Abdominal Aortic Aneurysm Repair a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-03
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:
None
Brief Summary:
The purpose of this program of research is to determine whether curcumin a natural health product can prevent acute kidney injury and other complications after elective AAA repair If proven safe and effective curcumin is an inexpensive intervention which can be readily applied to almost 50000 AAA repairs performed worldwide each year New knowledge about this intervention may also guide its use in other surgical and medical settings to prevent complications to the kidneys heart and other organs
Detailed Description:
An abdominal aortic aneurysm AAA is a ballooning of the abdominal aorta the major blood vessel of the body AAA occurs in up to 2 of adults Surgeons will plan an AAA repair when the aneurysm grows bigger than 55cm because the AAA might burst without repair Over 47000 AAA repairs are performed each year Despite the benefits of AAA repair there are risks and the kidneys can be severely injured We will test whether the natural health product curcumin has an effect on biomarkers of inflammation kidney injury and heart injury from AAA repair Curcumin appears to fight oxidation and inflammation which are ways that the body can be injured by surgery We will study 600 patients who have elective AAA repair The patients will receive either curcumin or a matching placebo We will recruit the 600 patients from 10 centres in Ontario This study will help us determine whether curcumin exerts any biological effect on biomarkers and whether it is well tolerated If there is evidence of beneficial effects in this 600 patient trial this will justify a future larger trial to assess the effects of curcumin on outcomes most important to patients families and their healthcare providers
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