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
• Status: Completed
• Phase: Phase 1
• Start date: November 2008
• Est. completion date: May 2010

Study information

• Verified date: November 2021
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Insufficiency
• Acute Renal Insufficiency
• Ischemia
• Ischemic Preconditioning
• Renal Insufficiency
• Wounds and Injuries

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.