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CompletedNCT03144258

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
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil · Other Government
Sex
All
Age
3 Months – 6 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2018-02-20
Primary completion
2018-12-30
Completion
2018-12-30
First posted
2017-05-08
Last updated
2019-08-21

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03144258. Inclusion in this directory is not an endorsement.

Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children (NCT03144258) · Clinical Trials Directory