Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI (EUROCRIPS)

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury

Treatments: Procedure: Sham remote ischemic preconditioning; Procedure: Remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02195726

201301

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,110 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,110 participants in 2 patient groups

Sham remote ischemic preconditioning'

Sham Comparator group

Description:

In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline

Treatment:

Procedure: Sham remote ischemic preconditioning

Remote ischemic preconditioning

Experimental group

Description:

In the experimental group, patients will receive for 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 upper than baseline), followed by 5-minute intervals of reperfusion. In subjects presenting with BMI \> 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation

Treatment:

Procedure: Remote ischemic preconditioning