An observational study in Congenital Heart Disease, Perioperative/Postoperative Complications and Lactate Blood Increase, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Prince of Songkla University · Observational
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
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's enrollment of 136 is above the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Prince of Songkla University is the lead sponsor of 116 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with cardiac disease in Songklanagarind hospital who undergone open cardiac surgery with cardiopulmonary bypass (age \< 18 years old)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
blood gas analysis
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: 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
Time frame: from time of subject was admitted to ICU until the 24 hour post operation
ventilator days
number of the days subject was intubated and used mechanical ventilator after operation
Time frame: 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
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
number of the days subject was stay in ICU after operation
Time frame: from date of subject was admitted to ICU until the date of subject was discharge, assessed up to 28 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — This data might be analyzed in other project and also we need to submit the form of data sharing to local EC unit.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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