APACHE Scoring SystemsNCT01162408
The Study of Clinical Value of Acute Physiologic and Chronic Health Evaluation (APACHE) Scoring System in Medical Intensive Care Unit
An observational study of APACHE Scoring Systems and Intensive Care Units, run by Sun Yat-sen University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- APACHE Scoring Systems, Intensive Care Units, Outcome Prediction
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients with an ICU stay more than 4 hours and age older than 16 years.
Who cannot join
- Patients with an ICU stay less than 4 hours and age less than 16 years.
About this study
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.
- Keywords
- ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for APACHE Scoring SystemsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162408
- Sponsor's protocol ID
- 123456
- Status last verified
- Jul 2010
- First submitted
- 13 Jul 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Clinical Value of Acute Physiologic and Chronic Health Evaluation (APACHE) Scoring System in Medical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01162408
- Acronym / sponsor ID
- 123456
- Keywords
- ICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2010
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Patients with an ICU stay more than 4 hours and age older than 16 years.
Key exclusion criteria (1 listed)
- Patients with an ICU stay less than 4 hours and age less than 16 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of APACHE Scoring Systems and Intensive Care Units, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2010.