About this trial
The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elective cardiac surgery with cardiopulmonary bypass
Written informed consent
Disqualifiers
Cardiac arrhythmia
Emergency operation
Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
Neoplasia
Trial design
Parallel
Treatments tested in this trial
Continuous central venous oxygenation monitoring
Other interventionCentral 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.
Standard protocol
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Lactate clearance
(\[lactate initial - lactate delayed\]/lactate initial) ×100%
Secondary outcomes
Length of Mechanical ventilation
hours
Vasopressors and inotropic therapy
hours
Cardiac complications
Low cardiac output syndrome , vasoplegia
Renal complications
Assess by pediatric RIFLE
Sponsors and contacts
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