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

NCT01225094 | Completed Phase 2 DMC

• 1 other identifier: 16593
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 10

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.

Conditions

Acute Kidney Injury; Abdominal Aortic Aneurysm

Keywords

AAA; abdominal aortic aneurysm; acute kidney injury; ischemia-reperfusion

Outcome Measures

Primary Outcomes (4)

• Urine IL-18

  We will examine the evidence of curcumin on biomarkers and whether it is well tolerated

  Post op value

• NT-ProBNP

  Change in post-operative minus pre-operative plasma NT-Pro BNP

• hsCRP

  Change in post-operative minus pre-operative plasma hsCRP

• Serum creatinine

  Change in peak post-operative serum creatinine (umol/L) in the 7 days following AAA repair minus pre-op value

Secondary Outcomes (3)

• Binary measures of continuous biomarker outcomes

  Continuous

• Safety outcomes

  Peri-operative period

• Composite clinical outcomes adjudicated by investigators unaware of treatment outcomes

  Within 30 days of AA repair

Other Outcomes (1)

• Other outcome measures

  Peri-operative period

Study Arms (2)

curcumin

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

curcumin 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 and then another 2000 mg dose 6 hours after the repair. Final dose is administered the morning after repair.

Also known as: NHPID name: curcumin

curcumin

placebo OTHER

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.

Also known as: No brand name applicable.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective repair of an AAA (excludes thoracic or thoracoabdominal aneurysms)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (10)

University of Calgary

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Sudbury Regional Hospital

Greater Sudbury, Ontario, P3E5J1, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6G 5W9, Canada

Location

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (1)

• 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.

  PMID: 30373740 DERIVED

Related Links

• Medline Plus related topics: Aneurysms Aortic Aneurysm
• Drug Information available for: Curcumin
• U.S. FDA Resources

MeSH Terms

Conditions

Acute Kidney Injury; Aortic Aneurysm, Abdominal

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Amit X Garg, MD, PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine, Epidemiology & Biostatistics

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: August 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

CA (10)