Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm (AAA) Repair

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Curcumin

Criteria

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