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The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.
Pediatric patients undergoing cardiac surgery are at risk for adverse clinical outcomes due a inadequate tissue perfusion. Recent studies have been demonstraded which the monitorization of continuos central venous saturation could be benneficial. There is evidence that monitoring continues venous oxygen saturation (ScvO2) can be beneficial in patient outcomes, guided by ScvO2 therapy has been associated with improved outcomes in resuscitation of critically ill patients with sepsis and after congenital heart surgery complexa. The early detection and treatment of tissue hypoxia can prevent morbidity and mortality. tissue hypoxia may be a result of the imbalance between supply (DO2) and oxygen consumption (VO2). If the fault supply, oxygen consumption is maintained by increased oxygen extraction resulting in decreased central venous oxygen saturation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal-directed therapy | Active Comparator | Patients randomized to this group will be monitoring by continuous central venous oxygen saturation. Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic. |
|
| Standard protocol | Other | The control group will keep the standard therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous central venous oxygenation monitoring | Other | Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic.
|
| Measure | Description | Time Frame |
|---|---|---|
| Lactate clearance | ([lactate initial - lactate delayed]/lactate initial) ×100% | at the beginning of surgery up to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Mechanical ventilation | hours | within 30 days after cardiac surgery |
| Vasopressors and inotropic therapy | hours | within 30 days after cardiac surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Filomena G Galas, Phd | Contact | +55 11 99319-0441 | filomenagalas@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Flavio M Ferreira, Phd | HCFUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incor - Heart Institute - University of Sao Paulo | Recruiting | São Paulo | 05403000 | Brazil |
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| Standard protocol | Other | The control group will keep the standard therapy to achieve mean arterial pressure higher than 50mmHg, central venous pressure 8 to 12 mmHg, urinay debit higher than 0,5ml/kg/h, hemoglobin higher or equal than 8g/dL, arterial oxygen saturation higher or equal than 92% in non-cyanogenic and 80% cyanogenic, central venous oxygen saturation higher or equal than 65% in non-cyanogenic and 55% in cyanogenic. |
|
| Cardiac complications | Low cardiac output syndrome , vasoplegia | within 30 days after cardiac surgery |
| Renal complications | Assess by pediatric RIFLE | within 30 days after cardiac surgery |
| Infection | Pneumonia, bloodstream, urinary, surgical site and/or sepsis | within 30 days after cardiac surgery |
| Length of ICU stay | days | within 30 days after cardiac surgery |
| Length of hospital stay | days | within 30 days after cardiac surgery |
| ID | Term |
|---|---|
| C077194 | AIEOP acute lymphoblastic leukemia protocol |
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