Remote Ischemic Preconditioning During Lower Limb Revascularization

NCT ID: NCT04016857

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Preconditioning Acute Kidney Injury Limb Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients were randomly assigned in 1:1 ratio to either control group or RIPC using computerized randomization table
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
The RIPC procedure were performed in the ward before going to operating room, and this is blinded to Investigators and surgical case anesthesiologist

Study Groups

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RIPC Group

Remote ischemic preconditioning

Group Type EXPERIMENTAL

RIPC

Intervention Type PROCEDURE

4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff

Control Group

Sham remote ischemic preconditioning

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

deflated cuff placed on the left arm for 40 min

Interventions

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RIPC

4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff

Intervention Type PROCEDURE

Control

deflated cuff placed on the left arm for 40 min

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Messina

OTHER

Sponsor Role lead

Responsible Party

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Alberto Noto

Professor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Noto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Messina

Locations

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A.O.U. G.Martino - University of Messina

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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UMEANE1

Identifier Type: -

Identifier Source: org_study_id

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