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NCT03144258 Clinical Trial

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

Congenital Heart Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03144258
Other study ID # CAAE 19201413.6.0000.5272
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 20, 2018
Est. completion date December 30, 2018

Study information
Verified date August 2019
Source National Institute of Cardiology, Laranjeiras, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 3 Months to 6 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil National Institute of Cardiology, Ministry of Health, Brazil Rio de Janeiro

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microcirculatory alterations during cardiopulmonary bypass Evaluation of the alterations of microcirculatory parameters and tissue perfusion during cardiopulmonary bypass in children submitted to cardiac corrective surgery for congenital heart defects december 2019
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