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Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

U

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

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

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.

Trial contacts and locations

1

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Central trial contact

Orlando Petrucci, MD, PhD

Data sourced from clinicaltrials.gov

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