Back to resultsEffect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
Primary Purpose
Heart Valve Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Automated cuff-inflator
Sponsored by
About this trial
This is an interventional prevention trial for Heart Valve Disease
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Automated cuff-inflator
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01023152
Brief Title
Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Automated cuff-inflator
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Automated cuff-inflator
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
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