Remote Ischemic Preconditioning During Lower Limb Revascularization

Not Applicable

Completed

• Conditions: Ischemic Preconditioning; Limb Ischemia; Acute Kidney Injury
• Interventions: Procedure: Control; Procedure: RIPC

• Registration Number: NCT04016857
• Lead Sponsor: University of Messina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Primary Completion: 2019-01-15
• Study Completion: 2019-06-15
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control	Sham remote ischemic preconditioning
RIPC Group	RIPC	Remote ischemic preconditioning

Primary Outcome Measures

Name	Time	Method
AKI	72 Hours	the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.

Secondary Outcome Measures

Name	Time	Method
AKI Risk Score	24 Hours	the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 \* IGFBP-7)

Trial Locations

Locations (1)

A.O.U. G.Martino - University of Messina; 🇮🇹 Messina, Italy