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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Amit Garg, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01225094
First received: October 19, 2010
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Acute Kidney Injury
Abdominal Aortic Aneurysm
Drug: curcumin
Other: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Curcumin to Prevent Perioperative Complications After Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Urine IL-18 [ Time Frame: Post op value ] [ Designated as safety issue: No ]
    We will examine the evidence of curcumin on biomarkers and whether it is well tolerated

  • NT-ProBNP [ Time Frame: Change in post-operative minus pre-operative plasma NT-Pro BNP ] [ Designated as safety issue: No ]
  • hsCRP [ Time Frame: Change in post-operative minus pre-operative plasma hsCRP ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binary measures of continuous biomarker outcomes [ Time Frame: Continuous ] [ Designated as safety issue: No ]
    e.g acute kidney injury defined using accepted criteria

  • Safety outcomes [ Time Frame: Peri-operative period ] [ Designated as safety issue: No ]
    Anemia, hypoglycemia, diarrhea, bleeding, peptic ulcer, nausea

  • Composite clinical outcomes adjudicated by investigators unaware of treatment outcomes [ Time Frame: Within 30 days of AA repair ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Other outcome measures [ Time Frame: Peri-operative period ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 600
Study Start Date: November 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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 is administered the morning after repair.
Other Name: NHPID name: curcumin
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.
Other: 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.
Other Name: No brand name applicable.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225094

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T3B 6A8
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre
London, Ontario, Canada, N6G 5W9
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada, K1Y4E9
Sudbury Regional Hospital
Sudbury, Ontario, Canada, P3E5J1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Amit X Garg, MD, PhD Lawson Health Research Institute
  More Information

Additional Information:
Responsible Party: Amit Garg, Professor, Medicine, Epidemiology & Biostatistics, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01225094     History of Changes
Other Study ID Numbers: 16593 
Study First Received: October 19, 2010
Last Updated: August 17, 2016
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
AAA
abdominal aortic aneurysm
acute kidney injury
ischemia-reperfusion

Additional relevant MeSH terms:
Aneurysm
Acute Kidney Injury
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Aortic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016