UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034921 |
|---|---|
| Receipt number | 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 03:00:36 |
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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
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
mario.youngmin@gmail.com
Sponsor or person
Institute
Northwell Health System
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039825
