Asia Pediatric Intensive Care Epidemiology and Outcomes Study

Recruiting

• Conditions: Critical Illness; Pediatrics; Intensive Care Unit

• Registration Number: NCT06481644
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

The overall objective of this study is to improve the standard of care of critically ill pediatric patients. The specific aims are to describe the clinical profile and outcomes of all admissions to Asian pediatric ICUs, determine the risk factors associated with poor outcomes, determine quality indicators for benchmarking ICU performance across sites and develop and train artificial intelligence algorithms to predict mortality, length of ICU stay and resource utilization.

Detailed Description

Critical illness is associated with high mortality and morbidity. The mortality rate in pediatric ICUs globally may vary from 2% in high resource settings to a 28% in low resource settings. This variable mortality outcome is due to several factors. There are differing patient populations (e.g. medical, surgical, oncology) who get admitted to the ICU and at different severity thresholds. Patients in the region are ethnically and genetically diverse. And lastly, ICU management itself is variable and dependent on expertise and resources. This study will adopt a multicentered prospective observational design. Data on patient demographics, clinical characteristics, ICU therapies, ICU quality indicators and outcomes will be recorded prospectively. Statistical analysis will include descriptive statistics, multivariable analysis, area under the receiver operating curve analysis and a variety of machine learning algorithms to achieve its aims.

Though the main methodology is recruitment of all pediatric ICU admissions, a pre-determined random sampling protocol is allowed for sites with limited in resources for recruitment and data collection. This protocol may involve recruitment of all admissions for 1year (52 weeks), all admissions for 1 month per quarter over 1 year (16 weeks), all admissions for 1 week per month over 1 year (12 weeks), all admissions for 2 weeks per quarter over 1 year (8 weeks) or all admissions for 1 week for quarter over 1 year (4 weeks) - this will be declared at the start of the study by each participating site before recruitment begins. This strategy will allow us to include sites with and without sufficient resources to be represented in this study. As ethics approval will take time, each site may enter the study at differing time points and recruit for 1 year. Patients who have previously consented under the Singapore Pediatric Intensive Care Registry (SG-PedIC) under a similar single-center pilot study protocol which started from 2020 may be included. In the statistical analysis, random down sampling may be performed to avoid over-representation from high recruitment sites.

Study Timeline

• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-03-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• All patients admitted to the pediatric ICUs of participant hospitals

Exclusion Criteria

• No consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Including 28-days and 60-days	ICU mortality and time based mortality

Secondary Outcome Measures

Name	Time	Method
ICU duration	Including 28-days and 60-days	ICU duration and ICU free days to account for mortality as competing outcome
Line associated thrombosis	Throughout ICU stay including 28-days and 60-days	Including venous or arterial clots related or unrelated to the presence of invasive catheters
Nosocomial infections	Throughout ICU stay including 28-days and 60-days	Including catheter related blood stream infection, catheter associated urinary tract infection hospital/ventilator associated pneumonia
Accidental extubations	Throughout ICU stay including 28-days and 60-days	Unplanned extubations
Unplanned ICU readmissions	Including readmissions within 24hour	Non-elective ICU readmissions
Ventilator duration	Including 28-days and 60-days	Ventilator duration and ventilator free days to account for mortality as competing outcome

Trial Locations

Locations (2)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

K K Women's and Children's Hospital; 🇸🇬 Singapore, Singapore