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

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ClinicalTrials.gov Identifier: NCT01023152
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:
Yonsei University

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Valve Disease Procedure: Automated cuff-inflator Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Parallel Assignment
Primary Purpose: Prevention

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Arm Intervention/treatment
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.





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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases