UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036025 |
|---|---|
| Receipt number | R000040875 |
| Scientific Title | Applicability of in-hospital mortality prediction score for patients with hypothermia in a Japanese community hospital setting |
| Date of disclosure of the study information | 2019/02/27 |
| Last modified on | 2020/08/15 17:38:26 |
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Basic information
Public title
Applicability of in-hospital mortality prediction score for patients with hypothermia in a Japanese community hospital setting
Acronym
Applicability of in-hospital mortality prediction score for patients with hypothermia
Scientific Title
Applicability of in-hospital mortality prediction score for patients with hypothermia in a Japanese community hospital setting
Scientific Title:Acronym
Applicability of in-hospital mortality prediction score for patients with hypothermia
Region
| Japan |
Condition
Condition
hypothermia
Classification by specialty
| Medicine in general | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the accuracy of in-hospital mortality prediction scores for patients with hypothermia in a Japanese community hospital setting.
Basic objectives2
Others
Basic objectives -Others
accuracy of the in-hospital mortality prediction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30 day mortality after admission
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 and more than 20 with principal diagnosis of hypothermia admitted to our hospital were included in the study.
Hypothermia was defined as core temperature less than 35 degrees Celsius, based on the definition by the International Classification of Diseases, Tenth Revision (ICD-10).
Key exclusion criteria
Patients without data on age, blood pressure, pH, or creatinine level. Patients with any incidences of mental confusion.
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Ishimaru |
Organization
Akashi Medical Center
Division name
Department of General Internal Medicine
Zip code
6740063
Address
Akashi
TEL
0789361101
maru-tkb@umin.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Ishimaru |
Organization
Akashi Medical Center
Division name
Department of General Internal Medicine
Zip code
6740063
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL
0789361101
Homepage URL
maru-tkb@umin.ac.jp
Sponsor or person
Institute
Akashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akashi Medical Center
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
Tel
0789361101
kawata@amc1.jp
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
| 2019 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/jgf2.323
Number of participants that the trial has enrolled
69
Results
We recruited 69 patients, 67 of which had analyzable data. The C-statistics of the in-hospital mortality prediction score was 0.703 (95% confidence interval, 0.55-0.84) for thirty-day survival prediction. After adjustment of the cutoff point of each item with ROC analysis and selection of the variants, the C-statistics of the in-hospital mortality prediction score rose to 0.81 (95% confidence interval, 0.69-0.92).
Results date posted
| 2020 | Year | 08 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 04 | Month | 27 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using medical records from initial hospital visits, we retrospectively calculated in-hospital mortality prediction scores along with discriminative value for in-hospital mortality.
Severity of hypothermia was further defined as either mild (between 32 degrees Celsius and 35 degrees Celsius), moderate (28 degrees Celsius to 32 degrees Celsius) or severe (less than 28 degrees Celsius) following classifications used by Durrer et al.
Demographic data, the presence of bacteremia, blood pressure, pH, creatinine level and any incidences of mental confusion were obtained from patient's charts.
Management information
Registered date
| 2019 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040875
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