Status:
COMPLETED
Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm (AAA) Repair
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Acute Kidney Injury
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 an...
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 grow...
Eligibility Criteria
Inclusion
- 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
- 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 the previous 6 months
- bleeding disorders: a diagnosis of hemophilia, von Willebrand disease, platelets less than 70 for any reason
- history of hypoglycemia in the past 6 months: blood sugar less than or equal to 3.5 mmol/L
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT01225094
Start Date
November 1 2011
End Date
August 1 2016
Last Update
March 7 2017
Active Locations (10)
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1
University of Calgary
Calgary, Alberta, Canada, T3B 6A8
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
3
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
4
Sudbury Regional Hospital
Greater Sudbury, Ontario, Canada, P3E5J1