Back to resultsRemote Ischemic Preconditioning During Lower Limb Revascularization
Primary Purpose
Ischemic Preconditioning, Acute Kidney Injury, Limb Ischemia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RIPC
Control
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Preconditioning focused on measuring remote ischemic preconditioning, lower limb revascularization, TIMP-2, IGFBP-7
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for open limb revascularization
Exclusion Criteria:
- Peripheral vascular disease affecting upper limbs
- Chronic kidney disease in stage 4 or 5 (eGFR<30 ml/min/1,73m2)
- Patients underwent contrast-enhanced radiological exams in the previous 7 days
- Treatment with glibencamide or prostaglandins
Sites / Locations
- A.O.U. G.Martino - University of Messina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
RIPC Group
Control Group
Arm Description
Remote ischemic preconditioning
Sham remote ischemic preconditioning
Outcomes
Primary Outcome Measures
AKI
the incidence of Acute Kidney Injury, defined as absolute rise of ≥ 0.3 mg/dL and/or a relative increase of 25% in serum creatinine compared to preoperative
AKI
the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.
Secondary Outcome Measures
AKI Risk Score
the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04016857
Brief Title
Remote Ischemic Preconditioning During Lower Limb Revascularization
Official Title
Effects of Remote Ischemic Preconditioning on Renal Outcomes Following Lower Limb Revascularization
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the role of remote ischemic preconditioning (RIPC) in preventing acute kidney injury after lower limb revascularization.
Remote ischemic preconditioning(RIPC) is a simple, cost-free and non invasive procedure (transient upper limb ischemia/reperfusion) that could provide organ protection (Heart, Brain and Kidney) following ischemia injuries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Preconditioning, Acute Kidney Injury, Limb Ischemia
Keywords
remote ischemic preconditioning, lower limb revascularization, TIMP-2, IGFBP-7
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients were randomly assigned in 1:1 ratio to either control group or RIPC using computerized randomization table
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The RIPC procedure were performed in the ward before going to operating room, and this is blinded to Investigators and surgical case anesthesiologist
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIPC Group
Arm Type
Experimental
Arm Description
Remote ischemic preconditioning
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Sham remote ischemic preconditioning
Intervention Type
Procedure
Intervention Name(s)
RIPC
Intervention Description
4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
deflated cuff placed on the left arm for 40 min
Primary Outcome Measure Information:
Title
AKI
Description
the incidence of Acute Kidney Injury, defined as absolute rise of ≥ 0.3 mg/dL and/or a relative increase of 25% in serum creatinine compared to preoperative
Time Frame
72 Hours
Title
AKI
Description
the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.
Time Frame
72 Hours
Secondary Outcome Measure Information:
Title
AKI Risk Score
Description
the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7)
Time Frame
24 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for open limb revascularization
Exclusion Criteria:
Peripheral vascular disease affecting upper limbs
Chronic kidney disease in stage 4 or 5 (eGFR<30 ml/min/1,73m2)
Patients underwent contrast-enhanced radiological exams in the previous 7 days
Treatment with glibencamide or prostaglandins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Noto, MD, PhD
Organizational Affiliation
University of Messina
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O.U. G.Martino - University of Messina
City
Messina
ZIP/Postal Code
98100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Ischemic Preconditioning During Lower Limb Revascularization
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