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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01162408
Other study ID # 123456
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 13, 2010
Last updated July 13, 2010
Start date July 2010

Study information

Verified date July 2010
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

Objective: To evaluate and compare the outcome predictive power of Acute Physiologic and Chronic Health Evaluation (APACHE) Ⅳ、Ⅲ、Ⅱ scoring systems for intensive ill patients in an independent medical intensive care unit (MICU), and explore the best time point when they can most accurately predict outcome.

Design: Retrospective analysis of medical records. Methods and Materials: Collect data of patients admitted between July 2010 and July 2013 to the medical intensive care unit of the First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China. Patients with an ICU stay less than 4 hours and age less than 16 years were excluded. Calculate the APACHE Ⅳ、Ⅲ、Ⅱ scores and corresponding predictive mortality risks in the first 24 hours of ICU admission and the 3th, 5th, 7th, 14th, 21 th, 28th day or the day of transferred out of ICU or death. The predictive power of each model was assessed through the ratio of observed death rates and predictive death rates (Standardized mortality ratios, SMR), the calibration of observed and predictive death rates and the discriminative ability between survivors and non-survivors. Hosmer-Lemeshow test was employed for assessing the calibration and the discriminative ability was assessed by the area under the receiver operating curve. Compare the predictive power of the three models at different time points and explore the the best time point when they can most accurately predict outcome.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with an ICU stay more than 4 hours and age older than 16 years.

Exclusion Criteria:

- Patients with an ICU stay less than 4 hours and age less than 16 years.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University
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