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Recruiting NCT03469440

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

No phase Interventional Heart; Dysfunction Postoperative, Cardiac Surgery C.Surgical Procedure; Cardiac

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous central venous oxygenation monitoring, Standard protocol.
Who it may be relevant to
Registry conditions: Heart; Dysfunction Postoperative, Cardiac Surgery, C.Surgical Procedure; Cardiac. Basic parameters: up to 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Continuous 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
  • Other Standard 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.

Primary outcome measures

  • Lactate clearance [Time frame: at the beginning of surgery up to 24 hours after surgery]
Secondary outcome measures (7)
  • Length of Mechanical ventilation [Time frame: within 30 days after cardiac surgery]
  • Vasopressors and inotropic therapy [Time frame: within 30 days after cardiac surgery]
  • Cardiac complications [Time frame: within 30 days after cardiac surgery]
  • Renal complications [Time frame: within 30 days after cardiac surgery]
  • Infection [Time frame: within 30 days after cardiac surgery]
  • Length of ICU stay [Time frame: within 30 days after cardiac surgery]
  • Length of hospital stay [Time frame: within 30 days after cardiac surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Incor - Heart Institute - University of Sao Paulo — São Paulo

Identifiers

NCT: NCT03469440 · 3988.13.113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗