UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019725
Receipt No. R000022780
Scientific Title The effect of blood glucose control by artificial endocrine pancreas on oxidative stress and postoperative AKI
Date of disclosure of the study information 2015/11/29
Last modified on 2019/06/14

* 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 The effect of blood glucose control by artificial endocrine pancreas on oxidative stress and postoperative AKI
Acronym BGAPOS
Scientific Title The effect of blood glucose control by artificial endocrine pancreas on oxidative stress and postoperative AKI
Scientific Title:Acronym BGAPOS
Region
Japan

Condition
Condition oxidative stress and acute kidney injury
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of the artificial endocrine pancreas for continuous monitoring and control of intraoperative blood glucose for oxidative stress and postoperative AKI in patients undergoing surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes oxidative stress
acute kidney injury
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
Device,equipment
Interventions/Control_1 intraoperative blood glucose control by artificial endocrine pancreas
Interventions/Control_2 controll blood glucose with manual injection of insulin based on a commonly used sliding scale
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 ASA PS 1-3
Key exclusion criteria patients need hemodyalysis
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Naoji
Middle name
Last name Mita
Organization Tokushima University Hospital
Division name anesthesiology
Zip code 770-8503
Address 2-50-1, Kuramoto-tyo, Tokushima, Japan
TEL 088-633-7181
Email mita@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Naoji
Middle name
Last name Mita
Organization Tokushima University Hospital
Division name anesthesiology
Zip code 770-8503
Address 2-50-1, Kuramoto-tyo, Tokushima, Japan
TEL 088-633-7181
Homepage URL
Email mita@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board,Tokushima University Hospital
Address 2-50-1, Kuramoto-tyo, Tokushima, Japan
Tel 088-633-9294
Email first-ec@tokushima-u.ac.jp

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 11 Month 29 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 40
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 No longer recruiting
Date of protocol fixation
2015 Year 11 Month 09 Day
Date of IRB
2016 Year 02 Month 03 Day
Anticipated trial start date
2015 Year 11 Month 27 Day
Last follow-up date
2020 Year 06 Month 30 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 11 Month 10 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022780

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.