NCT04541862

Brief Summary

Australian and New Zealand Intensive Care Society (ANZICS) has built an 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 intensive care unit (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. This database also add expansion of data include hourly vital signs data, more laboratory data, more diagnoses at admission and discharge, data after 24 hours till discharge, and extended information of clinical outcomes more than 30 days after admission to ICU . This database will retrospectively collect the data of patients discharged from intensive care after March 1, 2019 and will prospectively continue the retrospective collection of data till the patients discharged before June 30, 2043. The data will be used for the evaluation of quality and resource allocation, quality improvement, education of data science, datathon, and research to predict the clinical outcomes and assist the treatment strategies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
214mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Oct 2019Dec 2043

Study Start

First participant enrolled

October 23, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
22.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2043

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2043

Last Updated

September 9, 2020

Status Verified

August 1, 2020

Enrollment Period

23.6 years

First QC Date

August 30, 2020

Last Update Submit

September 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    Survival status at 30 days after ICU admission

    30 days

Secondary Outcomes (1)

  • Length of stay in intensive care unit

    Time to discharge from intensive care unit, a median of 2-7 days

Study Arms (1)

Critically ill patients

Other: Intensive care

Interventions

intensive care for critically ill patients in the intensive care units

Critically ill patients

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients admitted to intensive care units.

You may qualify if:

  • Critically ill patients admitted to intensive care units

You may not qualify if:

  • Patients aged less than 20 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Critical Care

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Yu-Chang Yeh, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2020

First Posted

September 9, 2020

Study Start

October 23, 2019

Primary Completion (Estimated)

June 1, 2043

Study Completion (Estimated)

December 1, 2043

Last Updated

September 9, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data available according to the regulation of Research Ethic Committee of National Taiwan University Hospital.

Locations