UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012323 |
|---|---|
| Receipt number | R000014353 |
| Scientific Title | The effect of dexmedetomidine in the acute decompensated heart failure |
| Date of disclosure of the study information | 2013/11/20 |
| Last modified on | 2013/11/18 10:10:54 |
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Basic information
Public title
The effect of dexmedetomidine in the acute decompensated heart failure
Acronym
The effect of dexmedetomidine in the acute decompensated heart failure
Scientific Title
The effect of dexmedetomidine in the acute decompensated heart failure
Scientific Title:Acronym
The effect of dexmedetomidine in the acute decompensated heart failure
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with ADHF,the sympathetic nerve system is activated highly. The ADHF of neurohumoral factors worsens the situation of ADHF.
Dexmedetomidine,sedative agent,alpha2-agonist,is supposed to suppress the sympathetic nerve system, in the acute phase,to suppress neurohumoral factors,to increase the urine output and improve survival survival rate. This study proves the effect of Dexmedetomidine in ADHF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Urine output,Catecholamine fraction(dopamine,adrenalin,noradrenalin),Renin activaion,aldosterone,ADH before and after the use od Dexmedetomidine in ADHF
Survival rate of one,three,five years
Key secondary outcomes
Creatinine,Heart rate,Blood pressure,Interleukin6,TNF-6,blood serum and urine Na K Cl,blood and urine osmotic pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
In the acute heart failure,
Carperitide administered in addition to the conventional diuretic and cardiotonic medicine
Interventions/Control_2
Instead of Carperitide,
Dexmedetomidine 0.4 ug/kg/h administered
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The acute decompensated heart failure which exhibits NYHA3/4
Key exclusion criteria
Under systoric blood pressure 80 mmHg
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | fukuda kenji |
Organization
Higashiosaka City General Hospital
Division name
cardiovascular medicine
Zip code
Address
3-4-5,nishiiwata,higashioosakashi,oosakafu
TEL
06-6781-5101
f.kenji.1812@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | fukuda kenji |
Organization
Higashiosaka City General Hospital
Division name
cardiovascular medicine
Zip code
Address
3-4-5,nishiiwata,higashioosakashi,oosakafu
TEL
06-6781-5101
Homepage URL
f.kenji.1812@gmail.com
Sponsor or person
Institute
Higashiosaka City General Hospital cardiovascular medicine
Institute
Department
Personal name
Funding Source
Organization
Higashiosaka City General Hospital
Organization
Division
Category of Funding Organization
Local Government
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
東大阪市立総合病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 20 | 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
| 2013 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 18 | Day |
Last modified on
| 2013 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014353
