Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI

Acute Kidney Injury Clinical Trial

— EUROCRIPS  

Official title:

The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195726
• Other study ID #: 201301
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2013
• Last updated: July 18, 2014
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1110
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Procedure:
• 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.
• Sham remote ischemic preconditioning
In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.

Locations

Country	Name	City	State
France	Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier	Paris
Italy	Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto	Grosseto
Italy	Azienda Ospedaliere Senese Siena	Siena
Italy	Città Della Salute e Della Scienza	Turin
Italy	Ospedale Maria Vittoria	Turin
Italy	San Luigi	Turin
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Countries where clinical trial is conducted

France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 and 48 hours after PCI	No
Secondary	Incidence of periprocedural myocardial infarction		24 and 48 hours after PCI	Yes

External Links

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