Congenital Heart DiseaseVACO2NCT06292910
Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery
An observational study of Congenital Heart Disease and Perioperative/Postoperative Complications, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Disease, Perioperative/Postoperative Complications, Lactate Blood Increase
- What is being tested?
- arterial and central venous blood gas analysis, lactate
- How many people
- 136 participants
- Where
- 1 siteThailand
- Study dates
- 8 Aug 2021to 26 Dec 2023
- Phase
- Observational
- 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 1 day to 18 years
- All sexes
- Child, Adult
Study population: Children with cardiac disease in Songklanagarind hospital who undergone open cardiac surgery with cardiopulmonary bypass (age < 18 years old)
Who may be able to join
- Children aged 0-18 years old with either congenital or acquired cardiac disease
- Undergone cardiopulmonary bypass for cardiac surgery
- Be admitted in PICU for post-operative care
Who cannot join
- Preterm infant (GA < 37 weeks) or weight less than 2 kg
- Patient who weaned off cardiopulmoanry bypass and required extracorporeal membrane oxygenator (ECMO) before leaving the operating room
- Patient who required emergency cardiac operation within 24 hour after hospitalization
- Patient who had significant residual left side outflow tract obstruction (e.g., coarctation of aorta, interrupted aortic arch) which defined by difference of SBP between upper and lower extremities more than 10 mmHg
- Patient who had already participated in another research project
- Patient who does not have both arterial line and central line catheter back from operating room
- Parents or legal guardian refuse to inform consent.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Predictability of Central Venous to Arterial CO2 Difference (AVCO2) in Children With Cardiac Surgery to Poor Outcomes
The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.
The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research
- Conditions
- Congenital Heart Disease, Perioperative/Postoperative Complications, Lactate Blood Increase
- Being tested
- arterial and central venous blood gas analysis, lactate
- Medical subject headings
- Heart Defects, Congenital, Postoperative Complications, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial and central venous blood gas analysis, lactateDiagnostic test
blood gas analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation
the low cardiac output syndrome (LCOS) related poor outcomes was diagnosed if at least two of the following criteria were met within 24 hours postoperatively:
- clinical LCOS: prolonged capillary refill >3 seconds, systolic blood pressure <5th percentile for age and sex, persistent elevation of left atrial pressure >10 mmHg for at least 6 hours, and low urinary output (<1 mL/kg/hour) for at least 6 hours despite diuretic use
- laboratory LCOS: persistently elevated lactate level (>2 mmol/L), metabolic acidosis with an increase in the base deficit (>4 mmol/L) for at least 6 hours consecutively
- Vasoactive-inotropic score ≥20
- any unplanned surgery or intervention, cardiac arrest, or utilization of ECMO
- left ventricular fraction <50% on echocardiography
Measured: from time of subject was admitted to ICU until the 24 hour post operation
Secondary outcomes (3)
ventilator days
number of the days subject was intubated and used mechanical ventilator after operation
Measured: from date of subject was admitted to ICU until the date of subject was extubated, assessed up to 28 days
inotrope days
number of the days subject was on inotropic medication after operation
Measured: from date of subject was admitted to ICU until the date of subject was free of inotropic drugs, assessed up to 28 days
length of stay in ICU
number of the days subject was stay in ICU after operation
Measured: from date of subject was admitted to ICU until the date of subject was discharge, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start8 Aug 2021
- Primary completion21 Dec 2023
- Study completion26 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pharsai Prasertsan, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292910
- Sponsor's protocol ID
- REC 64-299-1-1
- Acronym
- VACO2
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This data might be analyzed in other project and also we need to submit the form of data sharing to local EC unit.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Central Venous to Arterial CO2 Difference (AVCO2) in Children With Cardiac Surgery to Poor Outcomes
- ClinicalTrials.gov ID
- NCT06292910
- Acronym / sponsor ID
- VACO2 / REC 64-299-1-1
- Conditions
- Congenital Heart Disease, Perioperative/Postoperative Complications, Lactate Blood Increase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 5 Mar 2024 (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 goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.
The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with cardiac disease in Songklanagarind hospital who undergone open cardiac surgery with cardiopulmonary bypass (age < 18 years old)
Key inclusion criteria (3 listed)
- Children aged 0-18 years old with either congenital or acquired cardiac disease
- Undergone cardiopulmonary bypass for cardiac surgery
- Be admitted in PICU for post-operative care
Key exclusion criteria (7 listed)
- Preterm infant (GA < 37 weeks) or weight less than 2 kg
- Patient who weaned off cardiopulmoanry bypass and required extracorporeal membrane oxygenator (ECMO) before leaving the operating room
- Patient who required emergency cardiac operation within 24 hour after hospitalization
- Patient who had significant residual left side outflow tract obstruction (e.g., coarctation of aorta, interrupted aortic arch) which defined by difference of SBP between upper and lower extremities more than 10 mmHg
- Patient who had already participated in another research project
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 |
|---|---|---|
| arterial and central venous blood gas analysis, lactateblood gas analysis | Diagnostic test | – |
Primary outcome
number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation
Time frame: from time of subject was admitted to ICU until the 24 hour post operation
the low cardiac output syndrome (LCOS) related poor outcomes was diagnosed if at least two of the following criteria were met within 24 hours postoperatively: 1. clinical LCOS: prolonged capillary refill >3 seconds, systolic blood pressure <5th percentile for age and sex, persistent elevation of left atrial pressure >10 mmHg for at least 6 hours, and low urinary output (<1 mL/kg/hour) for at least 6 hours despite diuretic use 2. laboratory LCOS: persistently elevated lactate level (>2 mmol/L), metabolic acidosis with an increase in the base deficit (>4 mmol/L) for at least 6 hours consecutively 3. Vasoactive-inotropic score ≥20 4. any unplanned surgery or intervention, cardiac arrest, or utilization of ECMO 5. left ventricular fraction <50% on echocardiography
3 secondary outcomes
ventilator days
Time frame: from date of subject was admitted to ICU until the date of subject was extubated, assessed up to 28 days
inotrope days
Time frame: from date of subject was admitted to ICU until the date of subject was free of inotropic drugs, assessed up to 28 days
length of stay in ICU
Time frame: from date of subject was admitted to ICU until the date of subject was discharge, assessed up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided. This data might be analyzed in other project and also we need to submit the form of data sharing to local EC unit.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Perioperative/Postoperative Complications, run by Prince of Songkla University at 1 site in Thailand.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 5 Mar 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation (time frame: from time of subject was admitted to ICU until the 24 hour post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.