Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm (AAA) Repair (NCT01225094) | Clinical Trial Compass
CompletedPhase 2/3
Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm (AAA) Repair
Canada606 participantsStarted 2011-11
Plain-language 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 50,000 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Elective repair of an AAA (excludes thoracic or thoracoabdominal aneurysms)
* 18 years of age or older
* Able to provide informed consent
* Has one or more of the following criteria at time of preoperative assessment:
* x Open repair OR
* x Endovascular repair with ≥ 1 of the following criteria:
* o diabetes mellitus treated with insulin or oral hypoglycemic agents
* o age \> 70 years
* o pre-existing renal impairment (baseline serum creatinine level \>177 μmol/L for men or \>146 μmol/L for women)
* If diabetic, is able and willing to collect and record glucose levels at home
Exclusion Criteria:
* emergent or urgent repair (repair \< 3 days from pre-admission visit; ruptured AAA)
* prior renal transplantation
* pregnant or breastfeeding
* active gastrointestinal reflux disease, gastrointestinal ulcers or hepatobiliary disease (including gallstones)
* has active liver disease
* evidence of AKI (\> 50% increase in serum creatinine) in the 30 days prior to repair
* enrolled in another randomized controlled trial
* receipt of ≥ 1 dialysis treatment in the past week
* previous participation in this trial
* repair is scheduled \> 90 days from date of informed consent
* unable to provide written consent
* allergy(ies) to any member of the Zingiberaceae family: turmeric, ginger, curry, cumin, cardamom)
* allergy(ies) to ingredients of the study product or placebo: yellow or red food coloring, gelatin or cellulose
* have a history of major bleeding event in th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Urine IL-18
Timeframe: Post op value
2
NT-ProBNP
Timeframe: Change in post-operative minus pre-operative plasma NT-Pro BNP
3
hsCRP
Timeframe: Change in post-operative minus pre-operative plasma hsCRP
4
Serum creatinine
Timeframe: Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value
Trial details
NCT IDNCT01225094
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's