Database for Predicting Clinical Outcomes of Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Predicting Clinical Outcomes of Critically Ill Patients in Intensive Care Units With De-identification Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541849
• Other study ID #: 202004016RINB
• Status: Recruiting
• Start date: September 10, 2020
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: National Taiwan University Hospital
• Contact: Yu-Chang Yeh, MD, PhD
• Phone: +886-9-10513711
• Email: tonyyeh[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Australian and New Zealand Intensive Care Society (ANZICS) has built a Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of ICU database. National Taiwan University Hospital has joined this international collaboration and built the data according to the APD data dictionary with same value domain attributes and data element attributes. We retrospectively collected the data of patients discharged from the March 1, 2019 to June 30, 2022. Data of this database are permitted to study clinical problems and predict the clinical outcomes of these critically ill patients using statistical methods and machine learning techniques.

Description:

Data of this database are permitted to study the following clinical issues: including delirium, sepsis, acute kidney injury, acute respiratory distress syndrome, disseminated intravascular coagulation, multiple organ injuries, nutrition, survival status, number of days on ventilators, need for renal replacement therapy, length of stays in intensive care unit, length of stay in hospital, and other relevant clinical outcomes. It is also planned to analyze the clinical prognosis of special disease subgroups and establish a prediction model according to the type of patient's disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Critically ill patients admitted to intensive care units

Exclusion Criteria:

• patients aged less than 18 years

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Critical Care
Critical care in the intensive care units

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	mortality status at 30 days after admission to intensive care unit	30 days
Secondary	Length of stay in intensive care unit	number of days in intensive care unite	Time of discharge from intensive care unit, a median of 2-7 days
Secondary	Delirium	Events of delirium within 48 hours after ICU admission	48 hours
Secondary	Acute kidney Injury	Events of acute kidney injury within 48 hours; Time Frame:	48 hours
Secondary	Length of stay in intensive care unit	Number of days in intensive care unite	Time of discharge from hospital, more than 1 day
Secondary	Disseminated intravascular coagulation	Events of disseminated intravascular coagulation within 48 hours after ICU admission	48 hours
Secondary	Acute respiratory distress syndrome	Events of acute respiratory distress syndrome within 48 hours after ICU admission	48 hours