UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008194 |
|---|---|
| Receipt number | R000009660 |
| Scientific Title | Cold sweat is a significant predictor for trauma patients required interventions: A prospective observational study |
| Date of disclosure of the study information | 2012/06/20 |
| Last modified on | 2015/06/30 22:54:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Cold sweat is a significant predictor for trauma patients required interventions: A prospective observational study
Acronym
Cold sweat is a significant predictor for trauma patients required interventions: A prospective observational study
Scientific Title
Cold sweat is a significant predictor for trauma patients required interventions: A prospective observational study
Scientific Title:Acronym
Cold sweat is a significant predictor for trauma patients required interventions: A prospective observational study
Region
| Japan |
Condition
Condition
Traumatically injured patients
Classification by specialty
| Surgery in general | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether cold sweat is related to a predictor for trauma patients required intervention to resolve shock.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To calculate sensitivity, specificity, positive predictive value, and negative predictive value of cold sweat, regarding patients required interventions to resolve shock as positive.
Key secondary outcomes
To identify a common region of cold sweat.
To compare cold sweat with Shock Index and serum lactate as a predictor for intervention to resolve shock in trauma patients.
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All trauma patients transferred to the specialized facilities or others of a similar nature established by The Japanese Association for The Surgery of Trauma.
Key exclusion criteria
Patients who are transferred from another hospital, cardiac arrest, or with burn injury.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ujike Yoshihito |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7426
ujike@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumoto Tetsuya |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7427
Homepage URL
tyumoto@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 06 | Month | 20 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Prospective observational study
Management information
Registered date
| 2012 | Year | 06 | Month | 18 | Day |
Last modified on
| 2015 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009660
