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NCT04016857 Clinical Trial

Remote Ischemic Preconditioning During Lower Limb Revascularization

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04016857
Other study ID # UMEANE1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date June 15, 2019

Study information
Verified date September 2021
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 15, 2019
Est. primary completion date January 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• RIPC
4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff
• Control
deflated cuff placed on the left arm for 40 min

Locations
Country Name City State
Italy A.O.U. G.Martino - University of Messina Messina

Sponsors (1)
Lead Sponsor Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary AKI the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative. 72 Hours
Secondary AKI Risk Score the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7) 24 Hours
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