UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031805 |
|---|---|
| Receipt number | R000036310 |
| Scientific Title | Influence of different intraoperative infusion on acid-base balance |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/06/18 00:39:05 |
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Basic information
Public title
Influence of different intraoperative infusion on acid-base balance
Acronym
Influence of different intraoperative infusion on acid-base balance
Scientific Title
Influence of different intraoperative infusion on acid-base balance
Scientific Title:Acronym
Influence of different intraoperative infusion on acid-base balance
Region
| Japan |
Condition
Condition
Neurosurgical disease
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare the effects of the three kinds of Ringer's clinically frequently used on acid base balance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative arterial blood gas analysis result
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
bicarbonate Ringer's solution
from the introduction of anesthesia to the end of operation
Interventions/Control_2
acetate Ringer's solution
from the introduction of anesthesia to the end of operation
Interventions/Control_3
lactated Ringer's solution
from the introduction of anesthesia to the end of operation
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing neurosurgery
Patients who have obtained written informed consent from the patient
Key exclusion criteria
Patients who can not communicate
Cases judged inappropriate as subjects of this clinical trial by the research director / contributor
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kumiko Tanabe |
Organization
Gifu University hospital
Division name
Anesthesiology
Zip code
Address
Yanagido 1-1 Gifu city Gifu prefecture
TEL
0582306404
kumiko-t@m2.gyao.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitomi Sakurai |
Organization
Gifu Citizen's hospital
Division name
Anesthesiology
Zip code
Address
Kashimatyou 7-1 Gifu city Gifu prefecture
TEL
0582511101
Homepage URL
hito.maro2420@gmail.com
Sponsor or person
Institute
Gifu University hospital
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
| 2018 | Year | 04 | Month | 01 | 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
| 2018 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 04 | 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
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2018 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036310
