Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sham remote ischemic preconditioning'

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

Group Type SHAM_COMPARATOR

Sham remote ischemic preconditioning

Intervention Type PROCEDURE

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

Remote ischemic preconditioning

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

Group Type EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type PROCEDURE

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.

Interventions

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Remote ischemic preconditioning

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.

Intervention Type PROCEDURE

Sham remote ischemic preconditioning

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.