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

Sponsor

Robert Kramer, MD (Other)

Overall Status

Completed

CT.gov ID

NCT00821522

Collaborator

MaineHealth (Other)

120

Enrollment

Location

Arms

17.9

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual 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 :

Nov 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

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.

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

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. [48 hours after surgery.]

Secondary Outcome Measures

Oliguria. [12 hours after surgery.]
Incidence of acute kidney injury as defined by post-operative elevation in NGAL. [3 hours after cardiopulmonary bypass.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.