Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 14
SponsorInstituto do Coracao

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Continuous central venous oxygenation monitoring

    Other intervention

    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.

  • Standard protocol

    Other intervention

    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.

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: Goal-directed therapyActive comparator 1 intervention
Group B: Standard protocolOther 1 intervention

Trial outcomes

Primary outcomes

1

Lactate clearance

(\[lactate initial - lactate delayed\]/lactate initial) ×100%

Time frame
at the beginning of surgery up to 24 hours after surgery

Secondary outcomes

1

Length of Mechanical ventilation

hours

Time frame
within 30 days after cardiac surgery
2

Vasopressors and inotropic therapy

hours

Time frame
within 30 days after cardiac surgery
3

Cardiac complications

Low cardiac output syndrome , vasoplegia

Time frame
within 30 days after cardiac surgery
4

Renal complications

Assess by pediatric RIFLE

Time frame
within 30 days after cardiac surgery

Other outcomes

Sponsors and contacts

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