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

NCT ID: NCT03469440

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2024-12-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Goal-directed therapy

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.

Group Type: ACTIVE_COMPARATOR

Continuous central venous oxygenation monitoring

Intervention Type: OTHER

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.

Standard protocol

The control group will keep the standard therapy.

Group Type: OTHER

Standard protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Coracao

OTHER_GOV

Sponsor Role: lead

Responsible Party

Filomena R B G Galas

Associate Professor of Anesthesiology Departament

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavio M Ferreira, Phd

Role: PRINCIPAL_INVESTIGATOR

HCFUSP

Locations

Incor - Heart Institute - University of Sao Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Filomena G Galas, Phd

Role: CONTACT

filomenagalas@hotmail.com

+55 11 99319-0441

Facility Contacts

Filomena RG Galas

Role: primary

filomenagalas@hotmail.com

+551126615232

Other Identifiers

3988.13.113

Identifier Type: -

Identifier Source: org_study_id