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

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT03144258
• Lead Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

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.

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-08
• Study Start: 2018-02-20
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Institute of Cardiology, Ministry of Health, Brazil; 🇧🇷 Rio de Janeiro, Brazil