UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048711 |
|---|---|
| Receipt number | R000055504 |
| Scientific Title | Clinical evaluation of prognostic indicators using vital signs in critically ill patients |
| Date of disclosure of the study information | 2022/08/21 |
| Last modified on | 2023/08/22 09:21:45 |
* 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
Clinical evaluation of prognostic indicators using vital signs in critically ill patients
Acronym
Clinical evaluation of prognostic indicators using vital signs in critically ill patients
Scientific Title
Clinical evaluation of prognostic indicators using vital signs in critically ill patients
Scientific Title:Acronym
Clinical evaluation of prognostic indicators using vital signs in critically ill patients
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The validity and usefulness of scores calculated from vital sign data in intensive care units is unclear. In this study, we will examine the predictors of clinical events and changes in blood pressure and other parameters in critically ill patients based on vital sign data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictive accuracy of severity scores for clinical events and sustained hypotension
Key secondary outcomes
Frequency of alerts by severity score, time from alert to clinical event, time from alert to sustained hypotension
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 18 years and older managed in the HCU and ICU of Tokyo Women's Medical University Hospital between April and September 2019
Key exclusion criteria
Patients with left ventricular assist device, intraaortic balloon pumping, or extracorporeal membrane oxygenation
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nomura |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
tnomura@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Seino |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
yu-seino@ca2.so-net.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Nihon Kohden
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon Kohden
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
rinri.bm@twmu.ac.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
| 2022 | Year | 08 | Month | 21 | 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
1238
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
The score is calculated from the vital sign data of the enrolled patients stored in the intensive care information system, and the mean, maximum, and fluctuating values of the score, the frequency of alert occurrence, and the time between the occurrence of an alert and the occurrence of a clinical event or sustained hypotension are calculated and measured. Alert occurrence and its frequency are measured assuming that both score measuring devices are equipped.
Management information
Registered date
| 2022 | Year | 08 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055504
