UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008104 |
|---|---|
| Receipt number | R000009538 |
| Scientific Title | Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods. |
| Date of disclosure of the study information | 2012/06/08 |
| Last modified on | 2013/02/02 04:09:44 |
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Basic information
Public title
Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Acronym
Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Scientific Title
Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Scientific Title:Acronym
Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Region
| Japan |
Condition
Condition
The patients after cardiovascular surgery
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the blood pressure stability in the patients of noradrenaline infusion between simple exchange methods with step down methods.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure change (30min after exchange)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Simple exchange methods
Interventions/Control_2
Step down methods
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
The patients after cardiovascular surgery
Key exclusion criteria
High dose noradrenaline infusion (more than 0.2microg/kg/min)
Adrenaline infusion
Cardiac support with IABP and/or PCPS
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kota Kamizato |
Organization
University of the ryukyus
Division name
Department of anesthesiology
Zip code
Address
207Uehara Nishihara-cho OKINAWA,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of the ryukyus
Division name
Department of anesthesiology
Zip code
Address
207Uehara Nishihara-cho OKINAWA,Japan
TEL
Homepage URL
Sponsor or person
Institute
University of the ryukyus
Institute
Department
Personal name
Funding Source
Organization
University of the ryukyus
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
Address
Tel
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
| 2012 | Year | 06 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 05 | Day |
Last modified on
| 2013 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009538
