UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019638 |
|---|---|
| Receipt number | R000022697 |
| Scientific Title | The effect of glucose control by artificial endocrine pancreas during hepatectomy on postoperative AKI |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2019/07/25 19:56:08 |
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Basic information
Public title
The effect of glucose control by artificial endocrine pancreas during hepatectomy on postoperative AKI
Acronym
GAPAK
Scientific Title
The effect of glucose control by artificial endocrine pancreas during hepatectomy on postoperative AKI
Scientific Title:Acronym
GAPAK
Region
| Japan |
Condition
Condition
acute kidney injury
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of the closed-loop system, a type of artificial endocrine pancreas for continuous monitoring and control of intraoperative blood glucose for preventing postoperative AKI in patients undergoing hepatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative AKI
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
artificial endocrine pancreas for continuous monitoring and control of intraoperative blood glucose in patients undergoing hepatectomy
Interventions/Control_2
controll glucose level with a 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
patients undergoing hepatectomy
Key exclusion criteria
patients need hemodialysis
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
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
mita@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
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 | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
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 | 05 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 01 | 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 | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022697
