Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03144258

Enrollment

100

Registered

2017-05-08

Start date

2018-02-20

Completion date

2018-12-30

Last updated

2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

congenital heart defects, systemic microcirculation, laser Doppler perfusion imaging, cardiac corrective surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Months to 6 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Microcirculatory alterations during cardiopulmonary bypass	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

Countries

Brazil

Outcome results