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Clinical Trials/NCT03144258
NCT03144258
Completed
N/A

Evaluation of the Systemic Microcirculation in the Course of Cardiopulmonary Bypass Used in the Surgery for Repair of Congenital Heart Defects in Infants and Children

National Institute of Cardiology, Laranjeiras, Brazil1 site in 1 country100 target enrollmentFebruary 20, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
Enrollment
100
Locations
1
Primary Endpoint
Microcirculatory alterations during cardiopulmonary bypass
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.

Detailed Description

• Specific objectives: * To test the usefulness of skin laser Doppler flowmetry monitoring (LDPM) in the non-invasive evaluation of endothelium-dependent microvascular reactivity during CPB in children. * To investigate whether skin LDPM could be proposed as a clinical monitoring of tissue perfusion during CPB in pediatric cardiac surgery. * To investigate the effects of different anesthetic agents on microvascular reactivity during CPB. * To investigate the effects of cardiovascular and vasoactive drugs used during CPB on microvascular reactivity. * To evaluate the correlation of microcirculatory alterations observed during CPB with classical markers of tissue perfusion and oxygenation, including plasma lactate levels. * To evaluate the correlation of microcirculatory alterations observed during CPB with markers of systemic inflammation, including pro- and anti-inflammatory cytokines. * To evaluate the correlation of microcirculatory alterations observed during CPB with the plasma bioavailability of nitric oxide.

Registry
clinicaltrials.gov
Start Date
February 20, 2018
End Date
December 30, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
Responsible Party
Principal Investigator
Principal Investigator

Eduardo Tibirica, MD, PhD

Senior Researcher

National Institute of Cardiology, Laranjeiras, Brazil

Eligibility Criteria

Inclusion Criteria

  • infants and children with congenital heart defects scheduled to corrective cardiac surgery

Exclusion Criteria

  • age inferior to 3 months and superior to 6 years

Outcomes

Primary Outcomes

Microcirculatory alterations during cardiopulmonary bypass

Time Frame: december 2019

Evaluation of the alterations of microcirculatory parameters and tissue perfusion during cardiopulmonary bypass in children submitted to cardiac corrective surgery for congenital heart defects

Study Sites (1)

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