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.
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 5.5cm, because the AAA might burst without repair. Over 47,000 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
606
Patients will take the study medication (500 mg x 4 capsules, twice daily \[BID\]) for two days leading up to repair, totaling 4000 mg per day. They will take a dose (2000 mg) the morning of repair, at the same time as regular medications not held for surgery. While they are on call to the operating room, they will take another dose of 2000 mg and then another 2000 mg dose 6 hours after the repair. Final dose is administered the morning after repair.
The placebo will look, smell, taste, and in every way be identical to the active drug. Patients will take the study medication in the exact same manner as the curcumin regimen.
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Sudbury Regional Hospital
Greater Sudbury, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Urine IL-18
We will examine the evidence of curcumin on biomarkers and whether it is well tolerated
Time frame: Post op value
NT-ProBNP
Time frame: Change in post-operative minus pre-operative plasma NT-Pro BNP
hsCRP
Time frame: Change in post-operative minus pre-operative plasma hsCRP
Serum creatinine
Time frame: Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value
Binary measures of continuous biomarker outcomes
e.g acute kidney injury defined using accepted criteria
Time frame: Continuous
Safety outcomes
Anemia, hypoglycemia, diarrhea, bleeding, peptic ulcer, nausea
Time frame: Peri-operative period
Composite clinical outcomes adjudicated by investigators unaware of treatment outcomes
New acute dialysis, myocardial infarction, receipt of coronary revascularization, sepsis, pneumonia, non-fatal cardiac arrest, stroke, deep vein thrombosis, pulmonary embolism, lower limb amputation, ischemic bowel, congestive heart failure, death
Time frame: Within 30 days of AA repair
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