Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

University of Campinas, Brazil

Status: Unknown

Conditions: Coronary Artery Disease; Valvular Heart Disease

Treatments: Procedure: IRPC, Remote preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01906918

RIPC

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

IRPC, Remote preconditioning

Experimental group

Description:

This group will be submitted to ischemic preconditioning

Treatment:

Procedure: IRPC, Remote preconditioning

Control

Placebo Comparator group

Description:

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.