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

Congenital Heart Disease Clinical Trial

— VACO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06292910
• Other study ID #: REC 64-299-1-1
• Status: Completed
• Start date: August 8, 2021
• Est. completion date: December 26, 2023

Study information

• Verified date: February 2024
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 26, 2023
• Est. primary completion date: December 21, 2023
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Hyperlactatemia
• Lactate Blood Increase
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Diagnostic Test:
• arterial and central venous blood gas analysis, lactate
blood gas analysis

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from time of subject was admitted to ICU until the 24 hour post operation
Secondary	ventilator days	number of the days subject was intubated and used mechanical ventilator after operation	from date of subject was admitted to ICU until the date of subject was extubated, assessed up to 28 days
Secondary	inotrope days	number of the days subject was on inotropic medication after operation	from date of subject was admitted to ICU until the date of subject was free of inotropic drugs, assessed up to 28 days
Secondary	length of stay in ICU	number of the days subject was stay in ICU after operation	from date of subject was admitted to ICU until the date of subject was discharge, assessed up to 28 days