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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
May 8, 2017
CompletedStudy Start
First participant enrolled
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedAugust 21, 2019
August 1, 2019
10 months
May 4, 2017
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
infants and children with congenital heart defects scheduled to corrective cardiac surgery
You may qualify if:
- infants and children with congenital heart defects scheduled to corrective cardiac surgery
You may not qualify if:
- age inferior to 3 months and superior to 6 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Cardiology, Ministry of Health, Brazil
Rio de Janeiro, 22240-006, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Tibirica, MD, PhD
National Institute of Cardiology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
May 4, 2017
First Posted
May 8, 2017
Study Start
February 20, 2018
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
August 21, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share