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

Last updated: March 6, 2017
Sponsor: Lawson Health Research Institute
Overall Status: Completed

Phase

2/3

Condition

Aneurysm

Kidney Failure

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT01225094
16593
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 menor >146 μmol/L for women)

  • If diabetic, is able and willing to collect and record glucose levels at home

Exclusion

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 hepatobiliarydisease (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 foodcoloring, 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 lessthan 70 for any reason

  • history of hypoglycemia in the past 6 months: blood sugar less than or equal to 3.5mmol/L

Study Design

Total Participants: 606
Study Start date:
November 01, 2011
Estimated Completion Date:
August 31, 2016

Study 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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • St. Boniface Hospital

    Winnipeg, Manitoba R2H 2A6
    Canada

    Site Not Available

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6G 5W9
    Canada

    Site Not Available

  • The Ottawa Hospital, Civic Campus

    Ottawa, Ontario K1Y4E9
    Canada

    Site Not Available

  • Sudbury Regional Hospital

    Sudbury, Ontario P3E5J1
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B1W8
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N3M5
    Canada

    Site Not Available

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

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