RecruitingNot ApplicableNCT03469440

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

Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial


Sponsor

Instituto do Coracao

Enrollment

65 participants

Start Date

Feb 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 14 Years

Inclusion Criteria2

  • Elective cardiac surgery with cardiopulmonary bypass
  • Written informed consent

Exclusion Criteria6

  • Cardiac arrhythmia
  • Emergency operation
  • Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
  • Neoplasia
  • Heart transplant
  • Participation in another study

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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.


Locations(1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, Brazil

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