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Completed

NCT Number: NCT06292910

Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery

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

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hyperlactatemia Lactate Blood Increase Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Signs and Symptoms

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

arterial and central venous blood gas analysis, lactate

Diagnostic Test

blood gas analysis

Primary outcomes

  1. 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:

    • 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

Secondary outcomes

  1. ventilator days

    Time frame: from date of subject was admitted to ICU until the date of subject was extubated, assessed up to 28 days

    number of the days subject was intubated and used mechanical ventilator after operation

  2. 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

    number of the days subject was on inotropic medication after operation

  3. 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

    number of the days subject was stay in ICU after operation

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

Predictability of Central Venous to Arterial CO2 Difference (AVCO2) in Children With Cardiac Surgery to Poor Outcomes

Acronym: VACO2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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