Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation (REPAIR)
Primary Purpose
Acute Kidney Injury
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic preconditioning (RIPC)
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring acute kidney injury, percutaneous coronary intervention, remote ischemic preconditioning
Eligibility Criteria
Inclusion Criteria:
- Patients with diabetes undergoing percutaneous coronary intervention were included.
Exclusion Criteria:
- emergency PCI,
- baseline troponin value > 0.04 ng/mL,
- nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
- patient on dialysis,
- patients who had some inability to cooperate with the trial,
- those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.
Sites / Locations
- Beijing Anzhen Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
control group
remote ischemic preconditioning (RIPC) group
Arm Description
Control participants did not experience the procedure of transient upper-limb ischemia.
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.
Outcomes
Primary Outcome Measures
acute kidney injury
The primary study endpoint was AKI, defined as an absolute rise in serum creatinine of ≥ 0.5 mg/dl or a relative increase of ≥ 25% compared to baseline within 72 hours from PCI (the maximal measured concentration of serum creatinine during these 72 hours was used).
Secondary Outcome Measures
relative reduction in estimated glomerular filtration rate
Secondary endpoints were the relative reduction in estimated glomerular filtration rate (eGFR) as well as all cause mortality, myocardial infarction and stent thrombosis at 30-day and 180-day after procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01827891
Brief Title
Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
Acronym
REPAIR
Official Title
Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.
Detailed Description
Patients with diabetes undergoing elective percutaneous coronary intervention in Beijing Anzhen Hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (RIPC) group or control group. Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times. Control participants did not experience this procedure of transient upper-limb ischemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
acute kidney injury, percutaneous coronary intervention, remote ischemic preconditioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Control participants did not experience the procedure of transient upper-limb ischemia.
Arm Title
remote ischemic preconditioning (RIPC) group
Arm Type
Active Comparator
Arm Description
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.
Intervention Type
Procedure
Intervention Name(s)
remote ischemic preconditioning (RIPC)
Intervention Description
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.
Primary Outcome Measure Information:
Title
acute kidney injury
Description
The primary study endpoint was AKI, defined as an absolute rise in serum creatinine of ≥ 0.5 mg/dl or a relative increase of ≥ 25% compared to baseline within 72 hours from PCI (the maximal measured concentration of serum creatinine during these 72 hours was used).
Time Frame
72 hours after procedure
Secondary Outcome Measure Information:
Title
relative reduction in estimated glomerular filtration rate
Description
Secondary endpoints were the relative reduction in estimated glomerular filtration rate (eGFR) as well as all cause mortality, myocardial infarction and stent thrombosis at 30-day and 180-day after procedure.
Time Frame
180 days after procedure
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:
Patients with diabetes undergoing percutaneous coronary intervention were included.
Exclusion Criteria:
emergency PCI,
baseline troponin value > 0.04 ng/mL,
nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
patient on dialysis,
patients who had some inability to cooperate with the trial,
those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Learn more about this trial
Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
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