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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01023152
First received: December 1, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Valve Disease
 Procedure: Automated cuff-inflator

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Enrollment: 74
Arms Assigned Interventions
Experimental: Automated cuff-inflator 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Young Lan Kwak / Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital
ClinicalTrials.gov Identifier: NCT01023152     History of Changes
Other Study ID Numbers: 4-2008-0423
Study First Received: December 1, 2009
Last Updated: December 1, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Heart Valve Diseases
Acute Kidney Injury
Heart Diseases
Cardiovascular Diseases
 Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013