Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass

Heart Valve Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023152
• Other study ID #: 4-2008-0423
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: December 1, 2009

Study information

• Verified date: December 2009
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass.

Description:

Hypothesis : RIPC using tourniquet might be a simple technique with the benefit to provide renal protection without disturbing operating procedure and prolongation of total operating time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients undergoing complex valve surgery.

Exclusion Criteria:

• older than 80 years

• those with left main disease >50%, or hepatic or pulmonary disease

• active infective endocarditis

• left ventricular ejection fraction <30%

• myocardial infarction (MI) within 3 weeks

• pre-existing renal dysfunction (serum creatinine (Cr) level >1.4 mg/dl), and those with peripheral vascular disease affecting the lower limbs.

Study Design

Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Valve Disease
• Heart Valve Diseases

Intervention

Procedure:
• Automated cuff-inflator
RIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University