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OpenTrials
Completed

NCT Number: NCT04016857

Remote Ischemic Preconditioning During Lower Limb Revascularization

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.

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Key information

Conditions

Ischemic Preconditioning Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Limb Ischemia Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Messina, 98100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIPC

Procedure

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

Control

Procedure

deflated cuff placed on the left arm for 40 min

Primary outcomes

  1. AKI

    Time frame: 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

  2. AKI

    Time frame: 72 Hours

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

Secondary outcomes

  1. AKI Risk Score

    Time frame: 24 Hours

    the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7)

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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