UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011373 |
|---|---|
| Receipt number | R000010526 |
| Scientific Title | A study of the effect of low-dose hANP on Hb concentration and pulmonary function in prolonged anesthesia cases. |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2016/01/12 18:23:51 |
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Basic information
Public title
A study of the effect of low-dose hANP on Hb concentration and pulmonary function in prolonged anesthesia cases.
Acronym
A study of the effect of low-dose hANP on Hb concentration and pulmonary function in prolonged anesthesia cases.
Scientific Title
A study of the effect of low-dose hANP on Hb concentration and pulmonary function in prolonged anesthesia cases.
Scientific Title:Acronym
A study of the effect of low-dose hANP on Hb concentration and pulmonary function in prolonged anesthesia cases.
Region
| Japan |
Condition
Condition
patients with malignant tumor
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A study of the effect of low-dose hANP on Hb concentration and pulmonary function in prolonged anesthesia cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A study of the effect of low-dose hANP on Hb concentration and pulmonary function in prolonged anesthesia cases.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
low dose of hANp
Interventions/Control_2
control
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patietn with operation more than 8hour during anesthesia.
Key exclusion criteria
patient with chronic renal failure, diuretic, uncontrol DM, Hb under 7g/dl, pregnancy, difficult communication
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yokoyama |
Organization
Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University.
Division name
Department of Dental Anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka,812-8582 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University.
Division name
Department of Dental Anesthes
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 08 | Month | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 05 | Day |
Last modified on
| 2016 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010526
