NCT03469440

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Instituto do Coracao · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

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

Interventions

Type	Name	Description
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 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.
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.

Timeline

• Start date: 2018-02-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2018-03-19
• Last updated: 2024-08-23

Locations

1 site across 1 country: Brazil