Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery
Launched by INSTITUTO DO CORACAO · Mar 15, 2018
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment approach called goal-directed therapy for children who are having heart surgery. The aim is to see if using continuous monitoring of a specific measure called central venous saturation can improve care compared to the usual treatment. This study is focused on children who are scheduled for elective heart surgeries that require a heart-lung machine, which helps to pump blood and oxygen during the procedure.
To be eligible for this trial, children must be undergoing planned heart surgery and have parental consent. However, those with certain conditions like heart rhythm problems, emergency surgeries, or serious heart issues may not qualify. Participants will receive either the new therapy or standard care during their surgery, and the study will help researchers understand which approach leads to better outcomes. If you are considering this trial for your child, it’s important to discuss it with your healthcare team to understand all the details and what it involves.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Elective cardiac surgery with cardiopulmonary bypass
- • Written informed consent
- Exclusion Criteria:
- • Cardiac arrhythmia
- • Emergency operation
- • Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
- • Neoplasia
- • Heart transplant
- • Participation in another study
About Instituto Do Coracao
Instituto do Coração (InCor) is a leading clinical research institution dedicated to advancing cardiovascular health through innovative research and patient-centered care. As a prominent affiliate of the University of São Paulo, InCor focuses on the prevention, diagnosis, and treatment of heart diseases, harnessing cutting-edge technologies and methodologies to conduct clinical trials. The institute is committed to enhancing medical knowledge and improving patient outcomes by collaborating with healthcare professionals, researchers, and industry partners. With a strong emphasis on ethical practices and scientific rigor, InCor aims to contribute to the global understanding of cardiovascular conditions and foster the development of new therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Paulo, , Brazil
Patients applied
Trial Officials
Flavio M Ferreira, Phd
Principal Investigator
HCFUSP
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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