UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031805
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hito.maro2420@gmail.com

Sponsor
Institute Gifu University hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036310

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.