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NCT00821522 Clinical Trial

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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00821522
Other study ID # 3401
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 2008
Est. completion date May 2010

Study information
Verified date November 2021
Source MaineHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date May 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Remote Ischemic Preconditioning
Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.

Locations
Country Name City State
United States Maine Medical Center Portland Maine

Sponsors (2)
Lead Sponsor Collaborator
Robert Kramer, MD MaineHealth

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl. 48 hours after surgery.
Secondary Oliguria. 12 hours after surgery.
Secondary Incidence of acute kidney injury as defined by post-operative elevation in NGAL. 3 hours after cardiopulmonary bypass.
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