- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01225094
Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm (AAA) Repair
March 6, 2017 updated by: Amit Garg, Lawson Health Research Institute
Curcumin to Prevent Perioperative Complications After Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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
Enrollment (Actual)
606
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- University of Calgary
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface Hospital
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
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London, Ontario, Canada, N6G 5W9
- London Health Sciences Centre
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Ottawa, Ontario, Canada, K1Y4E9
- The Ottawa Hospital, Civic Campus
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Sudbury, Ontario, Canada, P3E5J1
- Sudbury Regional Hospital
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Toronto, Ontario, Canada, M4N3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5B1W8
- St. Michael's Hospital
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
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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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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine IL-18
Time Frame: Post op value
|
We will examine the evidence of curcumin on biomarkers and whether it is well tolerated
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Post op value
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NT-ProBNP
Time Frame: Change in post-operative minus pre-operative plasma NT-Pro BNP
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Change in post-operative minus pre-operative plasma NT-Pro BNP
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hsCRP
Time Frame: Change in post-operative minus pre-operative plasma hsCRP
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Change in post-operative minus pre-operative plasma hsCRP
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Serum creatinine
Time Frame: Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value
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Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binary measures of continuous biomarker outcomes
Time Frame: Continuous
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e.g acute kidney injury defined using accepted criteria
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Continuous
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Safety outcomes
Time Frame: Peri-operative period
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Anemia, hypoglycemia, diarrhea, bleeding, peptic ulcer, nausea
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Peri-operative period
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Composite clinical outcomes adjudicated by investigators unaware of treatment outcomes
Time Frame: Within 30 days of AA repair
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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
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Within 30 days of AA repair
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other outcome measures
Time Frame: Peri-operative period
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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
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Peri-operative period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amit X Garg, MD, PhD, Lawson Health Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
October 19, 2010
First Submitted That Met QC Criteria
October 19, 2010
First Posted (Estimate)
October 20, 2010
Study Record Updates
Last Update Posted (Actual)
March 7, 2017
Last Update Submitted That Met QC Criteria
March 6, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Aortic Diseases
- Acute Kidney Injury
- Aneurysm
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 16593
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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