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

Not Applicable

Recruiting

• Conditions: C.Surgical Procedure; Cardiac; Heart; Dysfunction Postoperative, Cardiac Surgery
• Interventions: Other: Standard protocol; Other: Continuous central venous oxygenation monitoring

• Registration Number: NCT03469440
• Lead Sponsor: Instituto do Coracao

Brief 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

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard protocol	Standard protocol	The control group will keep the standard therapy.
Goal-directed therapy	Continuous central venous oxygenation monitoring	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.

Primary Outcome Measures

Name	Time	Method
Lactate clearance	at the beginning of surgery up to 24 hours after surgery	(\[lactate initial - lactate delayed\]/lactate initial) ×100%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Incor - Heart Institute - University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil