UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015026 |
|---|---|
| Receipt number | R000017275 |
| Scientific Title | Response to infusion of noradrenalin and dobutamine during head up tilt in cardiovascular autonomic dysfunction in patients with neurodegenerative disorder. |
| Date of disclosure of the study information | 2014/09/05 |
| Last modified on | 2016/03/03 09:25:58 |
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Basic information
Public title
Response to infusion of noradrenalin and dobutamine during head up tilt in cardiovascular autonomic dysfunction in patients with neurodegenerative disorder.
Acronym
Response to infusion of noradrenalin and dobutamine during head up tilt in cardiovascular autonomic dysfunction in patients with neurodegenerative disorder.
Scientific Title
Response to infusion of noradrenalin and dobutamine during head up tilt in cardiovascular autonomic dysfunction in patients with neurodegenerative disorder.
Scientific Title:Acronym
Response to infusion of noradrenalin and dobutamine during head up tilt in cardiovascular autonomic dysfunction in patients with neurodegenerative disorder.
Region
| Japan |
Condition
Condition
neurodegenerating disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of our study was to evaluate changes in total peripheral resistance and cardio output during infusion of norepinefrine and dobutamine
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in blood pressure, heart rate, peripheral resistance and cardio output during drug load
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
a low dose of norepinephrine and dobutamine
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
neurodegenerating disease with autonomic dysfunction
Key exclusion criteria
Individuals with diabetes mellitus, any known heart disease, hypertension, Cussing syndrome, rheumatism, difficulty in blood drawing, or other neurological disorders were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sobue Gen |
Organization
Nagoya University Graduate School of Medicine
Division name
neurology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
+81-52-744-2385
sobueg@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ito Mizuki |
Organization
Nagoya University Graduate School of Medicine
Division name
neurology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
+81-52-744-2385
Homepage URL
itohm@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
| 2014 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26054882
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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 02 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017275
