Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

November 27, 2013 updated by: Orlando Petrucci, University of Campinas, Brazil

Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13100000
        • Recruiting
        • Hospital das Clínicas da UNICAMP
        • Contact:
        • Principal Investigator:
          • Orlando Petrucci, MD, PhD
        • Sub-Investigator:
          • Fany Lima, RN
        • Sub-Investigator:
          • Pedro Paulo M Oliveira, MD, PhD
        • Sub-Investigator:
          • Lindemberg M Silveira-Filho, MD, PhD
        • Sub-Investigator:
          • Karlos AS Vilarinho, MD, PhD
        • Sub-Investigator:
          • Elaine S Severino, MD, PhD
        • Sub-Investigator:
          • Daniela D Carvalho, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IRPC, Remote preconditioning
This group will be submitted to ischemic preconditioning
Procedure: 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.
PLACEBO_COMPARATOR: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Molecular pathway activation
Time Frame: 2 days
2 days
Inflammatory response
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause of mortality
Time Frame: 30 days
30 days
All cause of mortality
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Study Chair: Orlando Petrucci, MD, PhD, University of Campinas
  • Principal Investigator: Fany Lima, RN, University of Campinas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

July 21, 2013

First Submitted That Met QC Criteria

July 21, 2013

First Posted (ESTIMATE)

July 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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