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

NCT03469440 | Recruiting

• 1 other identifier: 3988.13.113
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lactate; central venous saturation; Pediatric Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Lactate clearance

  (\[lactate initial - lactate delayed\]/lactate initial) ×100%

  at the beginning of surgery up to 24 hours after surgery

Secondary Outcomes (7)

• Length of Mechanical ventilation

  within 30 days after cardiac surgery

• Vasopressors and inotropic therapy

  within 30 days after cardiac surgery

• Cardiac complications

  within 30 days after cardiac surgery

• Renal complications

  within 30 days after cardiac surgery

• Infection

  within 30 days after cardiac surgery

Study Arms (2)

Goal-directed therapy

ACTIVE COMPARATOR

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

Standard protocol

OTHER

The control group will keep the standard therapy.

Other: Standard protocol

Interventions

Continuous central venous oxygenation monitoring 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.

Goal-directed therapy

Standard protocol 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.

Standard protocol

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Elective cardiac surgery with cardiopulmonary bypass
• Written informed consent

You may not qualify if:

• Cardiac arrhythmia
• Emergency operation
• Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
• Neoplasia
• Heart transplant
• Participation in another study

Sponsors & Collaborators

• Instituto do Coracao: lead

Study Sites (1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Interventions

AIEOP acute lymphoblastic leukemia protocol

Study Officials

• Flavio M Ferreira, Phd

  HCFUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filomena G Galas, Phd

CONTACT

+55 11 99319-0441; filomenagalas@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology Departament

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 19, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)