UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037193 |
|---|---|
| Receipt number | R000042395 |
| Scientific Title | Factors associated with bias of noninvasive blood pressure and invasive intra-arterial blood pressure in critically ill patients. |
| Date of disclosure of the study information | 2019/06/30 |
| Last modified on | 2024/01/22 14:35:23 |
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Basic information
Public title
Factors associated with bias of noninvasive blood pressure and invasive intra-arterial blood pressure in critically ill patients.
Acronym
Factors associated with bias of noninvasive blood pressure and invasive intra-arterial blood pressure in critically ill patients.
Scientific Title
Factors associated with bias of noninvasive blood pressure and invasive intra-arterial blood pressure in critically ill patients.
Scientific Title:Acronym
Factors associated with bias of noninvasive blood pressure and invasive intra-arterial blood pressure in critically ill patients.
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the factors associated with bias of noninvasive blood pressure and invasive intra arterial blood pressure.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of noninvasive blood pressure and invasive intra arterial blood pressure.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all patients who meet following criteria
1) patients who are admitted to Intensive Care Units
2) patients whose blood pressure measured by invasively at radial
Key exclusion criteria
1) patients who are younger than 20 years old
2) patients who treated by extracorporeal circulation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Ouchi |
Organization
University of Tsukuba
Division name
Department go Emergency and Critical Care Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-3210
akira-ouchi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ouchi |
Organization
University of Tsukuba
Division name
Department go Emergency and Critical Care Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-3210
Homepage URL
akira-ouchi@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
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
Tsukuba Clinical Research and Development Organization
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
+81-29-853-3914
t-credo.adm@un.tsukuba.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
| 2019 | Year | 06 | Month | 30 | 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
150
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because of the shortage of manpower due to COVID-19.
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
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Predictive factors
APACHE II score, Diagnosis, Surgical Operation, Ventilator days, age, sex, BMI, Upper arm circumference, Comorbidity, fluid balance, medication(vasoactive, sedatives, analgesic), arrhythmia, inflammation related data
Statistics analysis
The multivariate analysis
Dependent variables: Predictive factors
Independent variable: Bias of noninvasive blood pressure and invasive intra arterial blood pressure
Management information
Registered date
| 2019 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042395
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
