Optimizing oxygen levels in children during heart surgery
Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial
NA · Instituto do Coracao · NCT03469440
This study tests if using special monitoring to keep oxygen levels just right can help children have better outcomes during heart surgery compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | N/A to 14 Years |
| Sex | All |
| Sponsor | Instituto do Coracao (other gov) |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT03469440 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of goal-directed therapy using continuous central venous saturation monitoring compared to standard therapy in pediatric patients undergoing cardiac surgery. The aim is to improve clinical outcomes by addressing inadequate tissue perfusion, which can lead to postoperative complications. By continuously monitoring central venous oxygen saturation, the study seeks to detect and treat tissue hypoxia early, potentially reducing morbidity and mortality associated with cardiac surgery. The intervention involves the use of advanced monitoring techniques alongside standard care protocols.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
Not a fit: Patients with cardiac arrhythmias, emergency operations, or severe hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and outcomes for children undergoing cardiac surgery.
How similar studies have performed: Previous studies have shown that continuous monitoring of central venous oxygen saturation can lead to improved outcomes in critically ill patients, suggesting potential success for this approach in pediatric cardiac surgery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo
- Incor - Heart Institute - University of Sao Paulo — São Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Flavio M Ferreira, Phd — HCFUSP
- Study coordinator: Filomena G Galas, Phd
- Email: filomenagalas@hotmail.com
- Phone: +55 11 99319-0441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart, Dysfunction Postoperative, Cardiac Surgery, C.Surgical Procedure, Cardiac, lactate, central venous saturation, Pediatric Cardiac Surgery