UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040074 |
|---|---|
| Receipt number | R000045698 |
| Scientific Title | Electronic alert for perioperative acute kidney injury: pragmatic randomized controlled trial |
| Date of disclosure of the study information | 2020/04/06 |
| Last modified on | 2021/09/21 18:57:59 |
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Basic information
Public title
Electronic alert for perioperative acute kidney injury
Acronym
E-alert study
Scientific Title
Electronic alert for perioperative acute kidney injury: pragmatic randomized controlled trial
Scientific Title:Acronym
E-alert AKI study
Region
| Japan |
Condition
Condition
acute kidney injury
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of electronic alert for perioperative kidney injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of acute kidney injury during postoperative 2 to 7 days.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
electronic AKI alert for detecting the increase of serum creatinine (0.3 mg/dL greater than or 50% greater than the lowest value)
Interventions/Control_2
Control group: no alert (usual care)
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
adults aged 20 years or older who will undergo surgery under general anesthesia in Mie University Hospital
Key exclusion criteria
1) no preoperative laboratory data including serum creatinine
2) preoperative creatinine 4.0 mg/dL or greater
3) patients with dialysis prior to surgery
4) emergency surgery
5) postponement of elective surgery
6) low risk surgery
7) can not obtain informed consent
8) invalid case
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yonekura |
Organization
Mie University Hospital
Division name
Department of Clinical Anesthesiology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5634
hyonekura@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yonekura |
Organization
Mie University Hospital
Division name
Department of Clinical Anesthesiology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5634
Homepage URL
hyonekura@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Clinical Anesthesiology, Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie
Tel
059-231-5634
kk-sien@mo.medic.mie-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
| 2020 | Year | 04 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | 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
| 2020 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045698
