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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

December 1, 2009
December 1, 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
Not Provided

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
Not Provided
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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01023152
4-2008-0423
No
Young Lan Kwak / Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital
Yonsei University
Not Provided
Not Provided
Yonsei University
December 2009

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