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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034921
Receipt No. R000039825
Scientific Title Comparing critical care systems to predict mortality in the surgical intensive care unit: Retrospective Cohort Study
Date of disclosure of the study information 2018/12/10
Last modified on 2018/11/22

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Basic information
Public title Comparing critical care systems to predict mortality in the surgical intensive care unit: Retrospective Cohort Study
Acronym Comparing critical care systems to predict mortality in the surgical intensive care unit: Retrospective Cohort Study
Scientific Title Comparing critical care systems to predict mortality in the surgical intensive care unit: Retrospective Cohort Study
Scientific Title:Acronym Comparing critical care systems to predict mortality in the surgical intensive care unit: Retrospective Cohort Study
Region
North America

Condition
Condition Comparison among predict score system in SICU patients
Classification by specialty
Medicine in general Surgery in general Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We set out to determine the predictive value of the APACHE I, APACHE III, SAPS and MODS scores for 30-day mortality, and determine the best model for predicting 30-day mortality.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 30-day SICU mortality was 10.9%. Discrimination was excellent for all scoring systems, as demonstrated by the area under the ROC curve, with values ranging from 0.81 to 0.86. There was a statistically significant difference between the APACHE III and APACHE I (p<0.0003) models, with APACHE III superior. Likewise, the APACHE III model was superior to MODS (p<0.0003). SAPS was also a better predictor of mortality when compared to MODS (p<0.0015).
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients in SICU for more than 30 days
Key exclusion criteria exclusion any patients less than 18
Target sample size 4311

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Barrera, Rafael
Organization Northwell health system
Division name Intensive unit care
Zip code
Address 27005 76th Ave, Queens, NY 11040
TEL +17184703000
Email Rbarrera@northwell.edu

Public contact
Name of contact person
1st name
Middle name
Last name Young Min Cho
Organization Feinstein Institute
Division name Pancreas disease center
Zip code
Address 150-49th 84th avenue, Jamaica
TEL +549292849021
Homepage URL
Email mario.youngmin@gmail.com

Sponsor
Institute Northwell Health System
Institute
Department

Funding Source
Organization No funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This was a chart retrospective review

Management information
Registered date
2018 Year 11 Month 18 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039825

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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