Clinical trial NCT06292910: Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery
Official title: Predictability of Central Venous to Arterial CO2 Difference (AVCO2) in Children With Cardiac Surgery to Poor Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Perioperative/Postoperative Complications
Lactate Blood Increase
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 136
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cardiac disease in Songklanagarind hospital who undergone open cardiac surgery with cardiopulmonary bypass (age \< 18 years old)

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation
timeFrame: from time of subject was admitted to ICU until the 24 hour post operation
Secondary outcomes:
measure: ventilator days
timeFrame: from date of subject was admitted to ICU until the date of subject was extubated, assessed up to 28 days
measure: inotrope days
timeFrame: from date of subject was admitted to ICU until the date of subject was free of inotropic drugs, assessed up to 28 days
measure: length of stay in ICU
timeFrame: from date of subject was admitted to ICU until the date of subject was discharge, assessed up to 28 days
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
References: