Remote Ischemic Preconditioning During Lower Limb Revascularization

September 27, 2021 updated by: Alberto Noto, University of Messina

Effects of Remote Ischemic Preconditioning on Renal Outcomes Following Lower Limb Revascularization

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Messina, Italy, 98100
        • A.O.U. G.Martino - University of Messina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RIPC Group
Remote ischemic preconditioning
4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff
SHAM_COMPARATOR: Control Group
Sham remote ischemic preconditioning
deflated cuff placed on the left arm for 40 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKI
Time Frame: 72 Hours
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
72 Hours
AKI
Time Frame: 72 Hours
the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.
72 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKI Risk Score
Time Frame: 24 Hours
the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7)
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alberto Noto, MD, PhD, University of Messina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2018

Primary Completion (ACTUAL)

January 15, 2019

Study Completion (ACTUAL)

June 15, 2019

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (ACTUAL)

July 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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