Remote Ischemic Preconditioning During Lower Limb Revascularization

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04016857

Enrollment

Registered

2019-07-12

Start date

2018-01-15

Completion date

2019-06-15

Last updated

2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Ischemic Preconditioning, Limb Ischemia

Keywords

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

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.

Interventions

PROCEDURERIPC

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

PROCEDUREControl

deflated cuff placed on the left arm for 40 min

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
AKI	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

Secondary

Measure	Time frame	Description
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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026