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

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 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


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

Value
https://center6.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