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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Maine Medical Center Research Institute

ClinicalTrials.gov Identifier:

NCT00821522

First received: January 9, 2009

Last updated: July 21, 2010

Last verified: April 2010

History of Changes

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Oliguria. [ Time Frame: 12 hours after surgery. ] [ Designated as safety issue: No ]
Incidence of acute kidney injury as defined by post-operative elevation in NGAL. [ Time Frame: 3 hours after cardiopulmonary bypass. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Robert F. Zimmerman, MD, Maine Medical Center Research Institute
ClinicalTrials.gov Identifier:	NCT00821522 History of Changes
Other Study ID Numbers:	3401
Study First Received:	January 9, 2009
Last Updated:	July 21, 2010
Health Authority:	United States: Institutional Review Board

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:

Ischemia
Acute Kidney Injury
Renal Insufficiency

Pathologic Processes
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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