UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021385 |
|---|---|
| Receipt number | R000024645 |
| Scientific Title | Evaluation of plasma expansion effect of hydroxyethyl starch -Randomized comparison study between two different molecular sized drugs- |
| Date of disclosure of the study information | 2016/03/10 |
| Last modified on | 2018/06/03 22:56:27 |
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Basic information
Public title
Evaluation of plasma expansion effect of hydroxyethyl starch
-Randomized comparison study between two different molecular sized drugs-
Acronym
Randomized comparison of plasma expansion effect between two different molecular sized HES drugs
Scientific Title
Evaluation of plasma expansion effect of hydroxyethyl starch
-Randomized comparison study between two different molecular sized drugs-
Scientific Title:Acronym
Randomized comparison of plasma expansion effect between two different molecular sized HES drugs
Region
| Japan |
Condition
Condition
Bilateral TKA planned patients under general anesthesia
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate longer hemodynamic stability effect of HES130/0.4 than HES 70/0.5
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hemodynamic stabilities at deflation of the tourniquet
Key secondary outcomes
changes of stroke volume variation (SVV)
cumulated dose of used vasopressor drugs
renal function(BUN,Cre)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
HES130/0.4 infusion group
(starting from induction of general anesthesia)
Interventions/Control_2
HES70/0.5 infusion group
(starting from induction of general anesthesia)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients planned to have bilateral TKA operation under general anesthesia with using tourniquet
Key exclusion criteria
patients with severe complications
tourniquet duration less than 30 minutes
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nishikawa |
Organization
Saitama cooperative hospital
Division name
department of Anesthesiology
Zip code
Address
1317 Kizoro Kawaguchi-shi Saitama
TEL
048-296-4771
diego1961jp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Iwakiri |
Organization
Tokyo Women's Medical University
Division name
department of Anesthesiology
Zip code
Address
8-1 Kawadacho Shinjuku-ku Tokyo
TEL
03-3353-8111
Homepage URL
mkthrk@ff.em-net.jp
Sponsor or person
Institute
Saitama cooperative hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama cooperative hospital
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
| 2016 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2016 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 10 | 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 | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024645
