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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| curcumin | Experimental | 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 (2000 mg)is administered morning after repair. |
|
| placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| curcumin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urine IL-18 | We will examine the evidence of curcumin on biomarkers and whether it is well tolerated | Post op value |
| NT-ProBNP | Change in post-operative minus pre-operative plasma NT-Pro BNP | |
| hsCRP | Change in post-operative minus pre-operative plasma hsCRP | |
| Serum creatinine | Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value |
| Measure | Description | Time Frame |
|---|---|---|
| Binary measures of continuous biomarker outcomes | e.g acute kidney injury defined using accepted criteria | Continuous |
| Safety outcomes | Anemia, hypoglycemia, diarrhea, bleeding, peptic ulcer, nausea |
| Measure | Description | Time Frame |
|---|---|---|
| Other outcome measures | Study medication adherence, length of hospital stay, pain, blood pressure 3 hours after repair, urine output 3 hours after repair, other urine and blood biomarkers, tracer outcomes | Peri-operative period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit X Garg, MD, PhD | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T3B 6A8 | Canada | ||
| University of Alberta Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30373740 | Derived | Garg AX, Devereaux PJ, Hill A, Sood M, Aggarwal B, Dubois L, Hiremath S, Guzman R, Iyer V, James M, McArthur E, Moist L, Ouellet G, Parikh CR, Schumann V, Sharan S, Thiessen-Philbrook H, Tobe S, Wald R, Walsh M, Weir M, Pannu N; Curcumin AAA AKI Investigators. Oral curcumin in elective abdominal aortic aneurysm repair: a multicentre randomized controlled trial. CMAJ. 2018 Oct 29;190(43):E1273-E1280. doi: 10.1503/cmaj.180510. |
| Label | URL |
|---|---|
| Medline Plus related topics: Aneurysms Aortic Aneurysm | View source |
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| placebo | Other | 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. |
|
|
| 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 | Within 30 days of AA repair |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Sudbury Regional Hospital | Greater Sudbury | Ontario | P3E5J1 | Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| London Health Sciences Centre | London | Ontario | N6G 5W9 | Canada |
| The Ottawa Hospital, Civic Campus | Ottawa | Ontario | K1Y4E9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N3M5 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| Drug Information available for: Curcumin | View source |
| U.S. FDA Resources | View source |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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