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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:
ClinicalTrials.gov Identifier:
NCT01023152
First Posted: December 2, 2009
Last Update Posted: December 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
December 1, 2009
December 2, 2009
December 2, 2009
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No Changes Posted
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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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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.
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.
Interventional
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Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Heart Valve Disease
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.
Experimental: Automated cuff-inflator
Intervention: Procedure: Automated cuff-inflator
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
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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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01023152
4-2008-0423
No
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Young Lan Kwak / Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital
Yonsei University
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Not Provided
Yonsei University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP