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

Primary Purpose

Acute Kidney Injury, Abdominal Aortic Aneurysm

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
curcumin
placebo
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring AAA, abdominal aortic aneurysm, acute kidney injury, ischemia-reperfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary
  • University of Alberta Hospital
  • St. Boniface Hospital
  • Hamilton General Hospital
  • London Health Sciences Centre
  • The Ottawa Hospital, Civic Campus
  • Sudbury Regional Hospital
  • Sunnybrook Health Sciences Centre
  • St. Michael's Hospital
  • Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

curcumin

placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Urine IL-18
We will examine the evidence of curcumin on biomarkers and whether it is well tolerated
NT-ProBNP
hsCRP
Serum creatinine

Secondary Outcome Measures

Binary measures of continuous biomarker outcomes
e.g acute kidney injury defined using accepted criteria
Safety outcomes
Anemia, hypoglycemia, diarrhea, bleeding, peptic ulcer, nausea
Composite clinical outcomes adjudicated by investigators unaware of treatment outcomes
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

Full Information

First Posted
October 19, 2010
Last Updated
March 6, 2017
Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01225094
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Abdominal Aortic Aneurysm
Keywords
AAA, abdominal aortic aneurysm, acute kidney injury, ischemia-reperfusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
606 (Actual)

8. Arms, Groups, and Interventions

Arm Title
curcumin
Arm Type
Experimental
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
curcumin
Other Intervention Name(s)
NHPID name: curcumin
Intervention 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 is administered the morning after repair.
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
No brand name applicable.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urine IL-18
Description
We will examine the evidence of curcumin on biomarkers and whether it is well tolerated
Time Frame
Post op value
Title
NT-ProBNP
Time Frame
Change in post-operative minus pre-operative plasma NT-Pro BNP
Title
hsCRP
Time Frame
Change in post-operative minus pre-operative plasma hsCRP
Title
Serum creatinine
Time Frame
Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value
Secondary Outcome Measure Information:
Title
Binary measures of continuous biomarker outcomes
Description
e.g acute kidney injury defined using accepted criteria
Time Frame
Continuous
Title
Safety outcomes
Description
Anemia, hypoglycemia, diarrhea, bleeding, peptic ulcer, nausea
Time Frame
Peri-operative period
Title
Composite clinical outcomes adjudicated by investigators unaware of treatment outcomes
Description
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
Time Frame
Within 30 days of AA repair
Other Pre-specified Outcome Measures:
Title
Other outcome measures
Description
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
Time Frame
Peri-operative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit X Garg, MD, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 5W9
Country
Canada
Facility Name
The Ottawa Hospital, Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
Facility Name
Sudbury Regional Hospital
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E5J1
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30373740
Citation
Garg AX, Devereaux PJ, Hill A, Sood M, Aggarwal B, Dubois L, Hiremath S, Guzman R, Iyer V, James M, McArthur E, Moist L, Ouellet G, Parikh CR, Schumann V, Sharan S, Thiessen-Philbrook H, Tobe S, Wald R, Walsh M, Weir M, Pannu N; Curcumin AAA AKI Investigators. Oral curcumin in elective abdominal aortic aneurysm repair: a multicentre randomized controlled trial. CMAJ. 2018 Oct 29;190(43):E1273-E1280. doi: 10.1503/cmaj.180510. Erratum In: CMAJ. 2018 Dec 3;190(48):E1425.
Results Reference
derived
Links:
URL
https://medlineplus.gov/aneurysms.html
Description
Medline Plus related topics: Aneurysms Aortic Aneurysm
URL
http://druginfo.nlm.nih.gov/drugportal/name/Curcumin
Description
Drug Information available for: Curcumin
URL
https://clinicaltrials.gov/ct2/info/fdalinks
Description
U.S. FDA Resources

Learn more about this trial

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

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