UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054663 |
|---|---|
| Receipt number | R000059254 |
| Scientific Title | Comparison in the method of exchanging noradrenaline syringes. |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/06/14 13:14:05 |
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Basic information
Public title
Comparison in the method of exchanging noradrenaline syringes.
Acronym
Comparison in the method of exchanging noradrenaline syringes.
Scientific Title
Comparison in the method of exchanging noradrenaline syringes.
Scientific Title:Acronym
Comparison in the method of exchanging noradrenaline syringes.
Region
| Japan |
Condition
Condition
All emergency department patients admitted to the emergency ward
Classification by specialty
| Emergency medicine | Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare two methods of noradrenaline syringe exchange, the "parallel exchange method" and the "simple exchange method," and to clarify differences in the adverse events and their effects on hemodynamics, in order to examine safer methods of noradrenaline syringe exchange.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Median mean blood pressure before and 10 minutes (per minute) after noradrenaline replacement in each group for the noradrenaline administration method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Collect data at the time of the first syringe replacement for patients who are receiving noradrenaline on a sustained dose in the emergency department
Implement syringe exchange using the "Parallel Exchange Method"
Blood pressure measurement before syringe replacement, measurement is performed for 10 minutes every minute immediately after administration
Interventions/Control_2
Collect data at the time of the first syringe replacement for patients who are receiving noradrenaline on a sustained dose in the emergency department
Implement syringe exchange using the "simple exchange method"
Blood pressure measurement before syringe replacement, measurement is performed for 10 minutes every minute immediately after administration
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
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All patients hospitalized in the emergency department
Including COVID-19 patients
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Iwamoto |
Organization
Fujieda Municipal General Hospital
Division name
Department of Emergency and Critical Care
Zip code
426-8677
Address
4-1-11, Surugadai, Fujieda, Shizuoka, Japan
TEL
0546461111
cocoa19831126@gmail.com
Public contact
Name of contact person
| 1st name | reiko |
| Middle name | |
| Last name | iwamoto |
Organization
Fujieda Municipal General Hospital
Division name
Emergency and critical care center
Zip code
4268677
Address
4-1-11, Surugadai, Fujieda, Shizuoka, Japan
TEL
0546461111
Homepage URL
cocoa19831126@gmail.com
Sponsor or person
Institute
Fujieda Municipal General Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Fujieda Municipal General Hospital
Address
4-1-11, Surugadai, Fujieda, Shizuoka, Japan
Tel
0546461111
cocoa19831126@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 14 | 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
26
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 | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059254
