Overview

This trial is active, not recruiting.

Conditions acute kidney injury, abdominal aortic aneurysm
Treatments curcumin, placebo
Phase phase 2/phase 3
Sponsor Lawson Health Research Institute
Collaborator Canadian Institutes of Health Research (CIHR)
Start date November 2011
End date July 2017
Trial size 600 participants
Trial identifier NCT01225094, 16593

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(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. Final dose (2000 mg)is administered morning after repair.
curcumin NHPID name: 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. Final dose is administered the morning after repair.
(Placebo Comparator)
The placebo will look, smell, taste, and in every way be identical to the active drug. Patients will take the study medication (4 capsules, twice daily [BID]) for two days leading up to repair. They will take a dose 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. Final dose is administered the morning after repair.
placebo No brand name applicable.
The placebo will look, smell, taste, and in every way be identical to the active drug. Patients will take the study medication (4 capsules, twice daily [BID]) for two days leading up to repair. They will take a dose 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.

Primary Outcomes

Measure
Urine IL-18
time frame: Change from baseline to post-op day 4 to 90 day followup
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

Secondary Outcomes

Measure
Binary measures of continuous biomarker outcomes
time frame: Continuous
Safety outcomes
time frame: From time of randomization to 90 day followup
Composite clinical outcomes adjudicated by investigators unaware of treatment outcomes
time frame: Within 30 days of AA repair
Clinical event
time frame: Randomization to 90 day followup

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Curcumin to Prevent Perioperative Complications After Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial
Principal investigator Amit X Garg, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.