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The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00821522
Recruitment Status : Unknown
Verified April 2010 by Maine Medical Center Research Institute.
Recruitment status was:  Enrolling by invitation
First Posted : January 13, 2009
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:
Maine Medical Center Research Institute

Study Description
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Brief Summary:
Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.

Condition or disease Intervention/treatment Phase
Acute Kidney Insufficiency Acute Renal Insufficiency Acute Kidney Injury Ischemic Preconditioning Procedure: Remote Ischemic Preconditioning Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery
Study Start Date : November 2008
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Preconditioning Procedure: Remote Ischemic Preconditioning
Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.
No Intervention: Control
Standard clinical management during cardiac surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl. [ Time Frame: 48 hours after surgery. ]

Secondary Outcome Measures :
  1. Oliguria. [ Time Frame: 12 hours after surgery. ]
  2. Incidence of acute kidney injury as defined by post-operative elevation in NGAL. [ Time Frame: 3 hours after cardiopulmonary bypass. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient undergoing heart surgery on cardiopulmonary bypass.

Exclusion Criteria:

  • Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.
  • End-stage renal disease.
  • Inability to give informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821522


Locations
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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center Research Institute
Investigators
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Principal Investigator: Robert F Zimmerman, MD Maine Medical Center Research Institute
More Information
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Responsible Party: Robert F. Zimmerman, MD, Maine Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00821522    
Other Study ID Numbers: 3401
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: April 2010
Keywords provided by Maine Medical Center Research Institute:
Acute Kidney Insufficiency
Acute Renal Insufficiency
Acute Kidney Injury
Cardiac Surgical Procedures
Ischemic Preconditioning
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Ischemia
Wounds and Injuries
 Pathologic Processes
Kidney Diseases
Urologic Diseases