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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name