Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery

NCT ID: NCT03517189

Last Updated: 2018-05-07

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2019-05-31

Brief Summary

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Introduction: Aorta no-touch off-pump coronary artery bypass surgery (OPCAB) has been the recommended technique for treatment of patients with high-risk of neurological damage or stroke. However, the displacement of the heart to achieve suitable exposure for graft construction elicits hemodynamic changes, potentially requiring conversion to on-pump. Objective: The aim of this study is to evaluate the sequential changes of hemodynamic parameters in patients that undergo aorta no-touch OPCAB. Method: Patients that undergo aorta no-touch OPCAB will be evaluated. The FloTrac / PreSep / Vigileo ™ (Edwards Lifesciences) system will be used to continuously record heart rate (HR), mean arterial pressure (DBP), central venous pressure (CVP), continuous cardiac index, systolic volume , systolic volume variation (VVS) and central venous oxygen saturation (ScvO2). The parameters will be evaluated 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending PD, marginal-OM and diagonal-Dg). Postoperative lactate will also be evaluated.

Detailed Description

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Conditions

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Cardiac Surgery Aorta No-touch

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aorta no-touch

Aorta no-touch off-pump coronary artery bypass surgery.

Group Type EXPERIMENTAL

Aorta no-touch

Intervention Type PROCEDURE

Participants will be submitted to aorta no-touch off-pump coronary artery bypass surgery.

Interventions

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Aorta no-touch

Participants will be submitted to aorta no-touch off-pump coronary artery bypass surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with a diagnosis of coronary artery disease with indication of myocardial revascularization surgery

Exclusion Criteria

* patients will be excluded if they presented clinically significant preoperative hepatic or renal dysfunction, thrombocytopenia, coagulopathy, or uncontrolled arrhythmia.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Solange Guizilini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Solange Guizilini, PhD

Role: primary

+5511982887753

Other Identifiers

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63054016.1.0000.5505

Identifier Type: -

Identifier Source: org_study_id

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