Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm (AAA) Repair
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01225094 |
Recruitment Status :
Completed
First Posted : October 20, 2010
Last Update Posted : March 7, 2017
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Condition or disease | Intervention/treatment | Phase |
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Acute Kidney Injury Abdominal Aortic Aneurysm | Drug: curcumin Other: placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 606 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Curcumin to Prevent Perioperative Complications After Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
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Experimental: curcumin
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.
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Drug: curcumin
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.
Other Name: NHPID name: curcumin |
Placebo Comparator: placebo
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.
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Other: placebo
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.
Other Name: No brand name applicable. |
- Urine IL-18 [ Time Frame: Post op value ]We will examine the evidence of curcumin on biomarkers and whether it is well tolerated
- 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 [ Time Frame: Continuous ]e.g acute kidney injury defined using accepted criteria
- Safety outcomes [ Time Frame: Peri-operative period ]Anemia, hypoglycemia, diarrhea, bleeding, peptic ulcer, nausea
- Composite clinical outcomes adjudicated by investigators unaware of treatment outcomes [ Time Frame: Within 30 days of AA repair ]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
- Other outcome measures [ Time Frame: Peri-operative period ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225094
Canada, Alberta | |
University of Calgary | |
Calgary, Alberta, Canada, T3B 6A8 | |
University of Alberta Hospital | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Canada, Manitoba | |
St. Boniface Hospital | |
Winnipeg, Manitoba, Canada, R2H 2A6 | |
Canada, Ontario | |
Hamilton General Hospital | |
Hamilton, Ontario, Canada, L8L 2X2 | |
London Health Sciences Centre | |
London, Ontario, Canada, N6G 5W9 | |
The Ottawa Hospital, Civic Campus | |
Ottawa, Ontario, Canada, K1Y4E9 | |
Sudbury Regional Hospital | |
Sudbury, Ontario, Canada, P3E5J1 | |
Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N3M5 | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B1W8 | |
Canada, Quebec | |
Maisonneuve-Rosemont Hospital | |
Montreal, Quebec, Canada, H1T 2M4 |
Principal Investigator: | Amit X Garg, MD, PhD | Lawson Health Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amit Garg, Professor, Medicine, Epidemiology & Biostatistics, Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT01225094 |
Other Study ID Numbers: |
16593 |
First Posted: | October 20, 2010 Key Record Dates |
Last Update Posted: | March 7, 2017 |
Last Verified: | March 2017 |
AAA abdominal aortic aneurysm acute kidney injury ischemia-reperfusion |
Acute Kidney Injury Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Vascular Diseases Cardiovascular Diseases Renal Insufficiency Kidney Diseases Urologic Diseases Aortic Diseases Curcumin |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |