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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arterial and central venous blood gas analysis, lactate | Diagnostic Test | blood gas analysis |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| from time of subject was admitted to ICU until the 24 hour post operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| inotrope days |
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Inclusion Criteria:
Exclusion Criteria:
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Children with cardiac disease in Songklanagarind hospital who undergone open cardiac surgery with cardiopulmonary bypass (age < 18 years old)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Prince of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand |
This data might be analyzed in other project and also we need to submit the form of data sharing to local EC unit.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2023 |
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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 |
| 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 |
| Feb 9, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D011183 | Postoperative Complications |
| D065906 | Hyperlactatemia |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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