Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

NCT ID: NCT01906918

Last Updated: 2013-11-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-08-31

Brief Summary

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Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.

Detailed Description

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Conditions

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Coronary Artery Disease Valvular Heart Disease

Keywords

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ischemia reperfusion myocardial ischemia myocardial reperfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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IRPC, Remote preconditioning

This group will be submitted to ischemic preconditioning

Group Type EXPERIMENTAL

IRPC, Remote preconditioning

Intervention Type PROCEDURE

The patients will be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion. This cycle will be repeated 4 times.

Control

This patients will be submitted to the standard surgery protocol in the institution. The patients will not be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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IRPC, Remote preconditioning

The patients will be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion. This cycle will be repeated 4 times.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years
* Scheduled for coronary artery bypass grafting with or without valve replacement associated
* Use of blood cardioplegia
* EuroSCORE II greater than or equal to 1.0%

Exclusion Criteria

* History of cardiogenic shock
* Complications in the admission
* Pregnant patients
* Severe peripheral arterial disease affecting the upper limbs
* Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃)
* Significant pulmonary disease (˂ FEV1 40%)
* Renal failure with glomerular filtration rate ˂ ml/min/1,73 m²
* Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Orlando Petrucci

Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orlando Petrucci, MD, PhD

Role: STUDY_CHAIR

University of Campinas

Fany Lima, RN

Role: PRINCIPAL_INVESTIGATOR

University of Campinas

Locations

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Hospital das Clínicas da Unicamp

Campinas, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Orlando Petrucci, MD, PhD

Role: CONTACT

Phone: +55 19 97253335

Email: [email protected]

Facility Contacts

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Fany Lima

Role: primary

Other Identifiers

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RIPC

Identifier Type: -

Identifier Source: org_study_id