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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06292910
Other study ID # REC 64-299-1-1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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