UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032769 |
|---|---|
| Receipt number | R000036948 |
| Scientific Title | Effect of low dose of noradrenaline on the hypotension in the patients with general surgery: Case controlled study |
| Date of disclosure of the study information | 2018/06/03 |
| Last modified on | 2020/12/14 17:35:08 |
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Basic information
Public title
Effect of low dose of noradrenaline on the hypotension in the patients with general surgery: Case controlled study
Acronym
Effect of low dose of noradrenaline on the hypotension in the patients with general surgery
Scientific Title
Effect of low dose of noradrenaline on the hypotension in the patients with general surgery: Case controlled study
Scientific Title:Acronym
Effect of low dose of noradrenaline on the hypotension in the patients with general surgery
Region
| Japan |
Condition
Condition
surgical patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is that investigate of the effect of low dose of noradrenaline on the hypotension in the patients with general surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the effect to raise blood pressure via low doses of noradrareline and dopamine and to examine the usefulness of noradrenaline
Key secondary outcomes
Prove the safety of noradrenaline use at low dose in surgical patients
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.patients over 20years old
2.It does not matter men and women
3.Patient agreed with this protocol
Key exclusion criteria
1. Patients with Pheochromocytoma
2. Shock aptients
3. Patients with Dialysis
4. Pregnat woman
5. Energency operation
6. Obviously death patient
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Tsuneyoshi |
Organization
Faculty of medicine University of Miyazaki
Division name
Department of Anesthesiology
Zip code
889-1692
Address
5200 Kihara Kiyotake Miyazaki
TEL
0985-85-9357
isao45@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Tsuneyoshi |
Organization
Faculty of medicine University of Miyazaki
Division name
Department of Anesthesiology
Zip code
889-1692
Address
5200 Kihara Kiyotake Miyazaki
TEL
0985-85-9357
Homepage URL
http://www.med.miyazaki-u.ac.jp/home/masui/
isao45@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology Faculty of medicine University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Clinical research support expenses in 2018
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
Anesthesiology
Address
5200 kihara kiyotake Miyazaki
Tel
0985-85-9357
isao45@med.miyazaki-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
| 2018 | Year | 06 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | 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
| 2020 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 29 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036948
