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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040074
Receipt No. 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 2020/04/06

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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
Email 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
Email hyonekura@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Clinical Anesthesiology, Mie University Hospital
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045698

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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