UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021685 |
|---|---|
| Receipt number | R000025015 |
| Scientific Title | Low-dose hANP increases urine volume and alleviates the decrease in hemoglobin concentration: a randomized controlled study |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/03/30 15:37:34 |
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Basic information
Public title
Low-dose hANP increases urine volume and alleviates the decrease in hemoglobin concentration: a randomized controlled study
Acronym
Low-dose hANP increases urine volume and alleviates the decrease in hemoglobin concentration.
Scientific Title
Low-dose hANP increases urine volume and alleviates the decrease in hemoglobin concentration: a randomized controlled study
Scientific Title:Acronym
Low-dose hANP increases urine volume and alleviates the decrease in hemoglobin concentration.
Region
| Japan |
Condition
Condition
orthopedic surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effect of low-dose hANP during orthopedic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urine volume, renal function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
hANP group
Interventions/Control_2
control group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
elective orthopedic surgery patients
Key exclusion criteria
history of cardiac, renal diseases or medication containing diuretic, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonist
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yokoyama |
Organization
Kyushu University
Division name
Department of Dental Anesthesiology, Faculty of Dental Science,
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582
TEL
092-642-6480
tsukamoto@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masanori tsukamoto |
Organization
Kyushu University
Division name
Department of Dental Anesthesiology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582
TEL
092-642-6480
Homepage URL
tsukamoto@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kochi university
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
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
高知大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2007 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025015
