UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050855 |
|---|---|
| Receipt number | R000057953 |
| Scientific Title | Clinical evaluation of prognostic indicators using vital signs in critically ill patients |
| Date of disclosure of the study information | 2023/04/14 |
| Last modified on | 2025/04/15 10:03:10 |
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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 early warning scores calculated from vital sign data in intensive care units is unclear. In this study, we will examines the accuracy of the scores calculated from vital sign data in predicting clinical events in critically ill patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Predictive accuracy of early warning scores for clinical events
Key secondary outcomes
The value of the scores, frequency of alerts by the scores, time from alert to clinical event, relationship between alerts by the scores and monitor alarms, type of clinical event, intervention status, and patient 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
| 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 G-HCU and g-ICU of St. Marianna Univerity Hospital between April and December 2023
Key exclusion criteria
Patients with left ventricular assist device, intraaortic balloon pumping, or extracorporeal membrane oxygenation
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Seino |
Organization
St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
yusuke.seino@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Seino |
Organization
St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
Homepage URL
yusuke.seino@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon Kohden Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of St. Marianna University
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
| 2023 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1000
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
| 2023 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The score is calculated from the vital sign data of the enrolled patients, 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
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057953
