UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019725
Receipt number 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 2021/05/16 02:05:32

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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 or person

Institute

Tokushima University Hospital

Institute

Department

Personal name



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

Completed

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 12 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

2021 Year 05 Month 16 Day



Link to view the page

Value
https://center6.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