Remote Ischemic Preconditioning During Lower Limb Revascularization

NCT04016857 | Completed

• 1 other identifier: UMEANE1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Preconditioning; Acute Kidney Injury; Limb Ischemia

Keywords

remote ischemic preconditioning; lower limb revascularization; TIMP-2; IGFBP-7

Outcome Measures

Primary Outcomes (2)

• 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

  72 Hours

• AKI

  the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.

  72 Hours

Secondary Outcomes (1)

• AKI Risk Score

  24 Hours

Study Arms (2)

RIPC Group

EXPERIMENTAL

Remote ischemic preconditioning

Procedure: RIPC

Control Group

SHAM COMPARATOR

Sham remote ischemic preconditioning

Procedure: Control

Interventions

RIPC PROCEDURE

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

RIPC Group

Control PROCEDURE

deflated cuff placed on the left arm for 40 min

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for open limb revascularization

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

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

Messina, 98100, Italy

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alberto Noto, MD, PhD

  University of Messina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The RIPC procedure were performed in the ward before going to operating room, and this is blinded to Investigators and surgical case anesthesiologist
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia

Model Details: patients were randomly assigned in 1:1 ratio to either control group or RIPC using computerized randomization table

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 12, 2019
• Study Start: January 15, 2018
• Primary Completion: January 15, 2019
• Study Completion: June 15, 2019
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)