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

Brief Title

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

Official Title

Curcumin to Prevent Perioperative Complications After Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial

Brief 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.
    

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 Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Urine IL-18

Secondary Outcome

 Binary measures of continuous biomarker outcomes

Condition

Acute Kidney Injury

Intervention

curcumin

Study Arms / Comparison Groups

 curcumin

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

606

Start Date

November 2011

Completion Date

August 2016

Primary Completion Date

November 2014

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Amit X Garg, MD, PhD, , 

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT01225094

Organization ID

16593

Responsible Party

Principal Investigator

Study Sponsor

Lawson Health Research Institute

Collaborators

 Canadian Institutes of Health Research (CIHR)

Study Sponsor

Amit X Garg, MD, PhD, Principal Investigator, Lawson Health Research Institute

Verification Date

March 2017