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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Maine Medical Center Research Institute.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00821522
First Posted: January 13, 2009
Last Update Posted: July 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maine Medical Center Research Institute
  Purpose
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 Intervention Phase
Acute Kidney Insufficiency Acute Renal Insufficiency Acute Kidney Injury Ischemic Preconditioning Procedure: Remote Ischemic Preconditioning Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Maine Medical Center Research Institute:

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

Estimated Enrollment: 120
Study Start Date: November 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center Research Institute
Investigators
Principal Investigator: Robert F Zimmerman, MD Maine Medical Center Research Institute
  More Information

Responsible Party: Robert F. Zimmerman, MD, Maine Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00821522     History of Changes
Other Study ID Numbers: 3401
First Submitted: January 9, 2009
First Posted: January 13, 2009
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:
Wounds and Injuries
Ischemia
Acute Kidney Injury
Renal Insufficiency
Pathologic Processes
Kidney Diseases
Urologic Diseases