UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047576 |
|---|---|
| Receipt number | R000054253 |
| Scientific Title | Evaluation of Pulse Wave Transit Time for Early Detection of Sepsis |
| Date of disclosure of the study information | 2022/04/25 |
| Last modified on | 2022/04/24 10:35:25 |
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Basic information
Public title
Evaluation of Pulse Wave Transit Time for Early Detection of Sepsis
Acronym
Evaluation of Pulse Wave Transit Time for Early Detection of Sepsis
Scientific Title
Evaluation of Pulse Wave Transit Time for Early Detection of Sepsis
Scientific Title:Acronym
Evaluation of Pulse Wave Transit Time for Early Detection of Sepsis
Region
| Japan |
Condition
Condition
Suspection of Sepsis
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Pulse Wave Transit Time for Early Detection of Sepsis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sepsis
Key secondary outcomes
Bacteremia, SOFA, Blood Gas, Lactate, Blood Pressure, Respiratory Rate, BUN, CRN
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
| 105 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ER patients with submittin an examination of blood culture under monitoring circulation status
Key exclusion criteria
under 20 years old
over 105 years old
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Yamashita |
Organization
Japanese Red Cross Society Kochi Hospital
Division name
Division of Critical Care
Zip code
7808562
Address
1-4-63-11 Hadaminamimachi, Kochi-shi, Kochi
TEL
0888221201
krch.yamashita2017@gmail.com
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Yamashita |
Organization
Japanese Red Cross Kochi Hospital
Division name
Division of Critical Care
Zip code
7808562
Address
1-4-63-11 Hadaminamimachi, Kochi-shi,Kochi
TEL
0888221201
Homepage URL
krch.yamashita2017@gmail.com
Sponsor or person
Institute
Japanese Red Cross Kochi Hospital, Division od Critical Care
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Society Kochi Hospital
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
Japanese Red Cross Kochi Hospital
Address
1-4-63-11 Hadaminamimachi, Kochi-shi, Kochi
Tel
0888221201
krch.yamashita2017@gmail.com
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
日本赤十字社 高知赤十字病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study data keep it on a computer independent of the Internet and are going to accumulate in the state that makes it the anonymity, and cannot connect it by giving an original reference number unlike the medical treatment number.
Management information
Registered date
| 2022 | Year | 04 | Month | 24 | Day |
Last modified on
| 2022 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054253
