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

Phase 1

Completed

• Conditions: Acute Renal Insufficiency; Acute Kidney Injury; Ischemic Preconditioning; Acute Kidney Insufficiency
• Interventions: Procedure: Remote Ischemic Preconditioning

• Registration Number: NCT00821522
• Lead Sponsor: Robert Kramer, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-13
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preconditioning	Remote Ischemic Preconditioning	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States