Back to resultsThe Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery
Primary Purpose
Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Insufficiency focused on measuring Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Cardiac Surgical Procedures, Ischemic Preconditioning
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing heart surgery on cardiopulmonary bypass.
Exclusion Criteria:
- Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.
- End-stage renal disease.
- Inability to give informed consent.
Sites / Locations
- Maine Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Preconditioning
Control
Arm Description
Standard clinical management during cardiac surgery.
Outcomes
Primary Outcome Measures
Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl.
Secondary Outcome Measures
Oliguria.
Incidence of acute kidney injury as defined by post-operative elevation in NGAL.
Full Information
NCT ID
NCT00821522
First Posted
January 9, 2009
Last Updated
November 9, 2021
Sponsor
Robert Kramer, MD
Collaborators
MaineHealth
1. Study Identification
Unique Protocol Identification Number
NCT00821522
Brief Title
The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery
Official Title
The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Kramer, MD
Collaborators
MaineHealth
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Ischemic Preconditioning
Keywords
Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Cardiac Surgical Procedures, Ischemic Preconditioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preconditioning
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard clinical management during cardiac surgery.
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning
Intervention Description
Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl.
Time Frame
48 hours after surgery.
Secondary Outcome Measure Information:
Title
Oliguria.
Time Frame
12 hours after surgery.
Title
Incidence of acute kidney injury as defined by post-operative elevation in NGAL.
Time Frame
3 hours after cardiopulmonary bypass.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient undergoing heart surgery on cardiopulmonary bypass.
Exclusion Criteria:
Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.
End-stage renal disease.
Inability to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F Zimmerman, MD
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
12. IPD Sharing Statement
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The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery
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