Heart; Dysfunction Postoperative, Cardiac SurgeryNCT03469440
Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery
A study testing Continuous central venous oxygenation monitoring and Standard protocol in people with Heart; Dysfunction Postoperative, Cardiac Surgery and C.Surgical Procedure; Cardiac, run by Instituto do Coracao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery, C.Surgical Procedure; Cardiac
- What is being tested?
- Continuous central venous oxygenation monitoring and Standard protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2018to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective cardiac surgery with cardiopulmonary bypass
- Written informed consent
Who cannot join
- Cardiac arrhythmia
- Emergency operation
- Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
- Neoplasia
- Heart transplant
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Incor - Heart Institute - University of Sao Paulo
São Paulo, 05403000
Filomena RG Galas, +551126615232, filomenagalas@hotmail.com
About this study
Official title: Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial
The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.
Read the 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
- Being tested
- Continuous central venous oxygenation monitoring, Standard protocol
- Keywords
- lactate, central venous saturation, Pediatric Cardiac Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous central venous oxygenation monitoringOther
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Continuous central venous oxygenation monitoring |
| Standard protocol | Other | The control group will keep the standard therapy. Receives: Other: Standard protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate clearance
([lactate initial - lactate delayed]/lactate initial) ×100%
Measured: at the beginning of surgery up to 24 hours after surgery
Secondary outcomes (7)
Length of Mechanical ventilation
hours
Measured: within 30 days after cardiac surgery
Vasopressors and inotropic therapy
hours
Measured: within 30 days after cardiac surgery
Cardiac complications
Low cardiac output syndrome , vasoplegia
Measured: within 30 days after cardiac surgery
Renal complications
Assess by pediatric RIFLE
Measured: within 30 days after cardiac surgery
Infection
Pneumonia, bloodstream, urinary, surgical site and/or sepsis
Measured: within 30 days after cardiac surgery
Length of ICU stay
days
Measured: within 30 days after cardiac surgery
Length of hospital stay
days
Measured: within 30 days after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Feb 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart; Dysfunction Postoperative, Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Filomena R B G Galas, Instituto do Coracao
- Investigators
- Flavio M Ferreira, Phd, Principal investigator, HCFUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469440
- Sponsor's protocol ID
- 3988.13.113
- Status last verified
- Aug 2024
- First submitted
- 28 Feb 2018
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira FM, Araujo DD, Dantas GM, Cunha LCC, Zeferino SP, Galas FB. Goal-directed therapy with continuous SvcO2 monitoring in pediatric cardiac surgery: the PediaSat single-center randomized trial. Braz J Anesthesiol. 2025 Jul-Aug;75(4):844614. doi: 10.1016/j.bjane.2025.844614. Epub 2025 Mar 28.
PubMed 40158850
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03469440
- Acronym / sponsor ID
- 3988.13.113
- Keywords
- lactate, central venous saturation, Pediatric Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-directed therapy | Active comparator | Other: Continuous central venous oxygenation monitoringPatients 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. |
| Standard protocol | Other | Other: Standard protocolThe control group will keep the standard therapy. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Elective cardiac surgery with cardiopulmonary bypass
- Written informed consent
Key exclusion criteria (6 listed)
- Cardiac arrhythmia
- Emergency operation
- Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
- Neoplasia
- Heart transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous central venous oxygenation monitoringCentral 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 | Goal-directed therapy |
| Standard protocolThe 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. | Other | Standard protocol |
Primary outcome
Lactate clearance
Time frame: at the beginning of surgery up to 24 hours after surgery
([lactate initial - lactate delayed]/lactate initial) ×100%
7 secondary outcomes
Length of Mechanical ventilation
Time frame: within 30 days after cardiac surgery
Vasopressors and inotropic therapy
Time frame: within 30 days after cardiac surgery
Cardiac complications
Time frame: within 30 days after cardiac surgery
Renal complications
Time frame: within 30 days after cardiac surgery
Infection
Time frame: within 30 days after cardiac surgery
Length of ICU stay
Time frame: within 30 days after cardiac surgery
Length of hospital stay
Time frame: within 30 days after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 40158850Ferreira FM, Araujo DD, Dantas GM, Cunha LCC, Zeferino SP, Galas FB. Goal-directed therapy with continuous SvcO2 monitoring in pediatric cardiac surgery: the PediaSat single-center randomized trial. Braz J Anesthesiol. 2025 Jul-Aug;75(4):844614. doi: 10.1016/j.bjane.2025.844614. Epub 2025 Mar 28.
- Individual participant dataSharing planned: No
Related trials for Heart; Dysfunction Postoperative, Cardiac Surgery
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
Not yet recruitingObservational study
Epigenetic Susceptibility to Inflammatory Complications After Cardiac Surgery
Organ Dysfunction, Inflammation in Cardiac Surgery
RecruitingObservational study
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State
Perioperative/Postoperative Complications, Postoperative Cognitive Dysfunction
Not yet recruitingObservational study
PCO₂ Gap and Lactate as Predictors of POCD After Cardiac Surgery
Postoperative Cognitive Dysfunction (POCD), Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio M Ferreira, Phd principal investigator
HCFUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous central venous oxygenation monitoring and Standard protocol in people with Heart; Dysfunction Postoperative, Cardiac Surgery and C.Surgical Procedure; Cardiac, run by Instituto do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filomena G Galas, Phd (+55 11 99319-0441, filomenagalas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate clearance (time frame: at the beginning of surgery up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.