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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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C.Surgical Procedure; Cardiac, Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention / Treatment
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* Other: Continuous central venous oxygenation monitoring
* Other: Standard protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Goal-directed therapy<br>Patients randomized to this group will be monitoring by continuous central venous oxygen saturation. Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic. | Other: Continuous central venous oxygenation monitoring<br>* 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.<br>|
| Other: Standard protocol<br>The control group will keep the standard therapy. | Other: Standard protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate clearance | ([lactate initial - lactate delayed]/lactate initial) ×100% | at the beginning of surgery up to 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Mechanical ventilation | hours | within 30 days after cardiac surgery | 
| Vasopressors and inotropic therapy | hours | within 30 days after cardiac surgery | 
| Cardiac complications | Low cardiac output syndrome , vasoplegia | within 30 days after cardiac surgery | 
| Renal complications | Assess by pediatric RIFLE | within 30 days after cardiac surgery | 
| Infection | Pneumonia, bloodstream, urinary, surgical site and/or sepsis | within 30 days after cardiac surgery | 
| Length of ICU stay | days | within 30 days after cardiac surgery | 
| Length of hospital stay | days | within 30 days after cardiac surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactate, central venous saturation, Pediatric Cardiac Surgery