Heart; Dysfunction Postoperative, Cardiac Surgery, C.Surgical Procedure; Cardiac
Conditions
Keywords
lactate, central venous saturation, Pediatric Cardiac Surgery
Brief summary
The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.
Detailed description
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
Interventions
OTHERContinuous central venous oxygenation monitoring
Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic. * First, isotonic crystalloid, 10 up to 20 mL/kg, will be administered in boluses to achieve continuous central venous oxygen saturation higher than 65% in non-cyanogenic and 55% in cyanogenic. * Second, if not achieved with fluid administration, will be targeted by initiating and titrating inotropics (dobutamine or milrinone). If the mean arterial pressure is lower than 50 mm Hg will be associated epinephrine. * If the ScvO2 is lower than 65% in non-cyanogenic and 55% in cyanogenic and the hemoglobin was lower than 8g/dl, red blood cells (20mL/Kg) will be transfused to achieve a hemoglobin level of at least 8g/dL.
OTHERStandard protocol
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.
Sponsors
Instituto do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactate clearance | at the beginning of surgery up to 24 hours after surgery | (\[lactate initial - lactate delayed\]/lactate initial) ×100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressors and inotropic therapy | within 30 days after cardiac surgery | hours |
| Cardiac complications | within 30 days after cardiac surgery | Low cardiac output syndrome , vasoplegia |
| Renal complications | within 30 days after cardiac surgery | Assess by pediatric RIFLE |
| Length of Mechanical ventilation | within 30 days after cardiac surgery | hours |
| Length of ICU stay | within 30 days after cardiac surgery | days |
| Length of hospital stay | within 30 days after cardiac surgery | days |
| Infection | within 30 days after cardiac surgery | Pneumonia, bloodstream, urinary, surgical site and/or sepsis |
Countries
Brazil
Contacts
Primary ContactFilomena G Galas, Phd
Outcome results
None listed