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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22240-006
    • National Institute of Cardiology, Ministry of Health, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

infants and children with congenital heart defects scheduled to corrective cardiac surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: congenital heart defects; systemic microcirculation; laser Doppler perfusion imaging; cardiac corrective surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: CAAE 19201413.6.0000.5272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No