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

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ClinicalTrials.gov Identifier: NCT01225094
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Amit Garg, Lawson Health Research Institute

October 19, 2010
October 20, 2010
March 7, 2017
November 2011
November 2014   (Final data collection date for primary outcome measure)
  • Urine IL-18 [ Time Frame: Post op value ]
    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 ]
  • hsCRP [ Time Frame: Change in post-operative minus pre-operative plasma hsCRP ]
  • Serum creatinine [ Time Frame: Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value ]
serum creatinine [ Time Frame: change from baseline to post-op day 4 ]
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.
Complete list of historical versions of study NCT01225094 on ClinicalTrials.gov Archive Site
  • Binary measures of continuous biomarker outcomes [ Time Frame: Continuous ]
    e.g acute kidney injury defined using accepted criteria
  • Safety outcomes [ Time Frame: Peri-operative period ]
    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 ]
    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
  • curcumin adherence and side effects [ Time Frame: one week ]
    We will record the total number of pills ingested, and reasons for non-adherence (such as adverse effects, inability to take the 6 hour post repair dose). We will assess the tolerability and side effects of curcumin through open ended questions and a patient assessment questionnaire administered the second day after the repair.
  • serum troponin [ Time Frame: day after repair ]
    Major perioperative cardiovascular events are part of a composite outcome for Phase B of the trial. We hypothesize curcumin will reduce perioperative cardiac events. To guide Phase B, in Phase A we will measure serum troponin, an established marker of myocardial ischemia and infarction. Elevations of serum troponin after elective open and endovascular AAA repair have been associated with worse long-term prognosis.
  • c-reactive protein [ Time Frame: day after repair ]
    We will consider the between group difference in the log transformed first day after repair (study day 2) serum high sensitivity c-reactive protein (CRP) measurement. CRP is an established marker of inflammation which appears to peak at this time after surgery. Given its anti-inflammatory properties, we hypothesize use of curcumin will result in lower CRP levels after surgery.
  • nadir systolic blood pressure 0 to 3 hours after surgery [ Time Frame: 0-3 hours after repair ]
    We will consider the between group difference in the nadir systolic blood pressure between the two groups. Blood pressure is influenced by many factors including cardiac function, renal function, pain and inflammation, all of which may be influenced by the use of curcumin. We hypothesize curcumin will reduce postoperative hypotension.
  • pain [ Time Frame: 2 days after repair ]
    Patients will be asked to describe their pain on a 10 point visual analogue scale on the second day after repair. A score of 0 will represent no pain at all, and a score of 10 will represent the worst possible pain. We hypothesize curcumin will reduce postoperative pain.
Other outcome measures [ Time Frame: Peri-operative period ]
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
Not Provided
 
Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm (AAA) Repair
Curcumin to Prevent Perioperative Complications After Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Acute Kidney Injury
  • Abdominal Aortic Aneurysm
  • 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
  • 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.
  • 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.
    Intervention: Drug: 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.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
606
3500
August 2016
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01225094
16593
Yes
Not Provided
Not Provided
Amit Garg, Lawson Health Research Institute
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Amit X Garg, MD, PhD Lawson Health Research Institute
Lawson Health Research Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP