Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children
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|ClinicalTrials.gov Identifier: NCT03144258|
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : May 3, 2018
|Condition or disease|
|Congenital Heart Disease|
• 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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
|Actual Study Start Date :||February 20, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144258
|Contact: Eduardo Tibirica, MD, PhDfirstname.lastname@example.org|
|Contact: Viviana Ugenti, MDemail@example.com|
|National Institute of Cardiology, Ministry of Health, Brazil||Recruiting|
|Rio de Janeiro, Brazil, 22240-006|
|Contact: Eduardo V Tibirica, MD, PhD +55-21-999146075 firstname.lastname@example.org|
|Principal Investigator:||Eduardo Tibirica, MD, PhD||National Institute of Cardiology|