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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Lawson Health Research Institute
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: December 21, 2012
Last verified: December 2012
  Purpose

The purpose of this study 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:
  • serum creatinine [ Time Frame: change from baseline to post-op day 4 to 90 day followup ] [ Designated as safety issue: No ]
    We will examine the between group difference in change in peak serum creatinine after repair. Serum creatinine is an established marker for the measurement of kidney function, and has been used in hundreds of randomized trials.


Secondary Outcome Measures:
  • Acute Kidney Injury [ Time Frame: From baseline creatinine values to post operative day 3 ] [ Designated as safety issue: No ]
    AKI is defined by serum creatinine elevations or use of dialysis.

  • Clinical Events [ Time Frame: From time of randomization to 90 day followup ] [ Designated as safety issue: Yes ]
    Overall event rates: Death, bleeding, cardiac events, pneumonia, sepsis/infection, new acute peptic ulcers, stroke, deep vein thrombosis/pulmonary embolism, congestive heart failure, lower limb amputation, pain (as of post-op day 2), nausea or diarrhea, hospital length of stay

  • Clinical events [ Time Frame: Randomization to 90 day follow-up ] [ Designated as safety issue: Yes ]
    Assessment of GI side effects: considering proportion of participants with episode of vomiting and diarrhea during the time they took the investigational medication.

  • Clinical event [ Time Frame: Randomization to 90 day followup ] [ Designated as safety issue: Yes ]
    Serum troponin: established marker for MI and infarction. We will measure values on the post-repair day 1 and compare proportion of each group who have detectable increase.


Estimated Enrollment: 3500
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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. 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. 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 (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 the morning after repair.
Other: placebo
The placebo will look, smell, taste, and in every way be identical to the active drug. 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.
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 can prevent the development of kidney injury and other problems from AAA repair. Curcumin appears to fight oxidation and inflammation, which are ways that the body can be injured by surgery. We will perform the first phase (Phase A) of this trial by studying 600 patients who have AAA repair. The patients will receive either curcumin or a placebo. We will recruit patients from 10 centres in Ontario. Phase A will help us assess side effects and see if curcumin can help prevent kidney injury. If curcumin is beneficial and well-tolerated we will expand the study to the next phase. The next phase (Phase B) will have a total of 3600 patients and will look at outcomes most important to patients and their physicians.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Amit X Garg, MD, PhD 519-685-8502 amit.garg@lhsc.on.ca
Contact: Virginia Schumann, MLT, CCRC 519-685-8500 ext 33214 virginia.schumann@lhsc.on.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Matthew James, MD       mjames@ucalgary.ca   
Principal Investigator: Matthew James, MD         
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Neesh Pannu, MD    780-4076-8520    npannu@ualberta.ca   
Principal Investigator: Neesh Pannu, MD         
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Dolores Friesen, RN       dfriesen8@sbgh.mb.ca   
Principal Investigator: Manish M Sood, MD FRCPC         
Sub-Investigator: Randy Guzman         
Canada, Ontario
Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Heather Gill    905-527-4322 ext 40654    heather.gill@phri.ca   
Principal Investigator: Philip J Devereaux, MD, PhD         
Sub-Investigator: Michael Walsh, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6G 5W9
Contact: Amit X Garg, MD, PhD    519-685-8502    amit.garg@lhsc.on.ca   
Contact: Virginia Schumann, MLT, CCRC, CCRP    519-685-8500 ext 33214    virginia.schumann@lhsc.on.ca   
Principal Investigator: Amit X Garg, MD, PhD         
Sub-Investigator: Jeremy Harris, MD         
Sub-Investigator: Tom Forbes, MD         
The Ottawa Hospital, Civic Campus Recruiting
Ottawa, Ontario, Canada, K1Y4E9
Contact: Ellie Gee, RN    613-798-5555 ext 16467    egee@ottawahospital.on.ca   
Principal Investigator: Andrew Hill, MD         
Sub-Investigator: Swapnil Hiremath, MD         
Sudbury Regional Hospital Recruiting
Sudbury, Ontario, Canada, P3E5J1
Contact: Sumit Sharan, MD       sumit.sharan@hotmail.com   
Principal Investigator: Sumit Sharan, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Rosa Marticorena, RN, CRC    416-864-6060 ext 3214    marticorenar@smh.toronto.on.ca   
Principal Investigator: Ron Wald, MD         
Principal Investigator: Alan Lossing, MD         
Principal Investigator: Vern Campbell, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Nancy Perkins    416-480-6100 ext 7054    nancy.perkins@sunnybrook.ca   
Sub-Investigator: Michelle Hladunewich, MD         
Sub-Investigator: Sheldon Tobe, MD         
Canada, Quebec
Maisonneuve-Rosemont Hospital Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Lucie Lepeine    514 252-3400 ext 4689    llepine.hmr@ssss.gouv.qc.ca   
Principal Investigator: Georges Ouellet, MD FRCPC         
Sub-Investigator: Vincent Pichette, MD PhD         
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

No publications provided

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: December 21, 2012
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:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aneurysm
Acute Kidney Injury
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014