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

Instituto do Coracao

Status

Enrolling

Conditions

C.Surgical Procedure; Cardiac

Heart; Dysfunction Postoperative, Cardiac Surgery

Treatments

Other: Standard protocol

Other: Continuous central venous oxygenation monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT03469440

3988.13.113

Details and patient eligibility

About

The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.

Full 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

Enrollment

65 estimated patients

Sex

All

Ages

Under 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

65 participants in 2 patient groups

Goal-directed therapy

Active Comparator group

Description:

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.

Treatment:

Other: Continuous central venous oxygenation monitoring

Standard protocol

Other group

Description:

The control group will keep the standard therapy.

Treatment:

Other: Standard protocol