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Remote 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
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 8, 2019
Last Updated
September 27, 2021
Sponsor
University of Messina
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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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