Database for Predicting Clinical Outcomes of Critically Ill Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Other: Critical Care

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Yu-Chang Yeh, MD, PhD; Phone Number: +886-9-10513711; Email: tonyyeh@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yu-Chang Yeh, MD, PhD; Phone Number: +886-910513711; Email: tonyyeh@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to intensive care units

Description

Inclusion Criteria:

• Critically ill patients admitted to intensive care units

Exclusion Criteria:

• patients aged less than 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients	Other: Critical Care; Critical care in the intensive care units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	mortality status at 30 days after admission to intensive care unit	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Delirium	Events of delirium within 48 hours after ICU admission	48 hours
Acute kidney Injury	Events of acute kidney injury within 48 hours Time Frame:	48 hours
Length of stay in intensive care unit	Number of days in intensive care unite	Time of discharge from hospital, more than 1 day
Disseminated intravascular coagulation	Events of disseminated intravascular coagulation within 48 hours after ICU admission	48 hours
Acute respiratory distress syndrome	Events of acute respiratory distress syndrome within 48 hours after ICU admission	48 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 202004016RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual participant data available according to the regulation of research ethic committee of National Taiwan University Hospital.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No