Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI

Phase 4CompletedNCT02195726

A.O.U. Città della Salute e della Scienza1,110 enrolled

Overview

The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.

Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication. Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,110

Conditions

Acute Kidney Injury

Interventions

Remote ischemic preconditioningPROCEDURE

four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.

Sham remote ischemic preconditioningPROCEDURE

In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * undergoing PCI with stenting for all clinical indications * carrying (with) a renal clearance less than 60 mL/min/1.73 m2 and more than 30 mL/min/1.73 m2 (evaluated through MDRD); ù * younger than 85 years old. Exclusion Criteria: * ST Segment Elevation Myocardial Infarction (STEMI), unstable hemodynamic presentations (cardiogenic shock) or ongoing severe arrhythmias;

Locations (7)

Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier

Paris, France

Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto

Grosseto, Italy

Azienda Ospedaliere Senese Siena

Siena, Italy

Ospedale Maria Vittoria

Turin, Italy

Outcomes

Primary Outcomes

Incidence of acute kidney injury

Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration

Time frame: 24 and 48 hours after PCI

Secondary Outcomes

Incidence of periprocedural myocardial infarction

Time frame: 24 and 48 hours after PCI

Data from ClinicalTrials.gov

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