UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019001 |
|---|---|
| Receipt number | R000021981 |
| Scientific Title | Effect of hydroxyethyl starch 130/0.42 infusion on circulating blood volume and plasma drug concentration during general anesthesia |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2021/03/05 09:38:44 |
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Basic information
Public title
Effect of hydroxyethyl starch 130/0.42 infusion on circulating blood volume and plasma drug concentration during general anesthesia
Acronym
Effect of hydroxyethyl starch 130/0.42 infusion on circulating blood volume and plasma drug concentration
Scientific Title
Effect of hydroxyethyl starch 130/0.42 infusion on circulating blood volume and plasma drug concentration during general anesthesia
Scientific Title:Acronym
Effect of hydroxyethyl starch 130/0.42 infusion on circulating blood volume and plasma drug concentration
Region
| Japan |
Condition
Condition
Patient undergoing elective surgery under general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of hydroxyethyl starch 130/0.42 rapid infusion on circulataing blood volume and plasma drug concentration during general anesthesia comparing with the bicarbonate Ringer's solution
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Circulating blood volume, Plasma rocuroniumu concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Rapid colloid infusion for less than half an hour
Interventions/Control_2
Rapid crystalloid infusion for less than half an hour
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
Key inclusion criteria
Patients undergoing elective surgery under general anesthesia
Key exclusion criteria
neurologic disorder; significant heart, respiratory, hepatic, or renal imparement
cardiovascular disease; recent use of psychoactive medicine; body mass index greater than 30
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Miyake |
Organization
Japan Self Defense Force Hospital Yokosuka
Division name
Department of Anesthesiology
Zip code
Address
1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL
046-823-0270
y.miyake0520@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Miyake |
Organization
Japan Self Defense Force Hospital Yokosuka
Division name
Department of Anesthesiology
Zip code
Address
1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL
046-823-0270
Homepage URL
y.miyake0520@gmail.com
Sponsor or person
Institute
Japan Self Defense Force Hospital Yokosuka
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 09 | Month | 14 | 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
| 2015 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021981
