Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography

May 29, 2015 updated by: Marcello F Salgado Filho, MD, Federal University of Juiz de Fora

Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography

This is a double blind randomization study, assessing hemodynamic response in patients who underwent a cardiopulmonary bypass graft (CABG) with cardiopulmonary bypass (CPB) using intraoperative trasnesophageal echocardiography (TEE) to know what inotropic drug will be batter to improve the heart function. Epinephrine, milrinone, dobutamine and levosimendan will be assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 4

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
    • RJ
      • Rio de janeiro, RJ, Brazil, 3600-100
        • National Institute of Cardiology / Ministry of Health

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

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sinusal ritmus
  • EF > 35%
  • Elective CABG surgery

Exclusion Criteria:

  • No accept
  • Severe valvular regurgitation or stenoses
  • Chest pain
  • Cardiogenic shock

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: epinephrine
Assessment of systolic and diastolic heart function during CABAG with CPB with levosimendan using TEE.
Drug: epinephrine and levosimendan
epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)
Active Comparator: levosimendan
Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine using TEE.
Drug: epinephrine and levosimendan
epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and diastolic heart function
Time Frame: Two years
Assessment the systolic and diastolic heart function
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality after CABAG
Time Frame: Two years
Assessment mortality after CABAG
Two years

Collaborators and Investigators

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

Sponsor

Federal University of Juiz de Fora

Collaborators

Universidade Federal do Rio de Janeiro
National Institute of Cardiology/Ministry of Health

Investigators

  • Principal Investigator: Marcello F Salgado Filho, Master, National Institute of Cardiology/Ministry of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

February 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0362/14-12-2011

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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