Congenital Heart Disease, Lactate Blood Increase, Perioperative/Postoperative Complications
Conditions
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
Interventions
DIAGNOSTIC_TESTarterial and central venous blood gas analysis, lactate
blood gas analysis
Sponsors
Prince of Songkla University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ventilator days | 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 |
| inotrope days | 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 |
| length of stay in ICU | 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 |
Countries
Thailand
Outcome results
None listed