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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046093
Receipt No. R000052612
Scientific Title Double blind study of furosemide for Acute Kidney Injury(AKI)
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/17

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Basic information
Public title Double blind study of furosemide for Acute Kidney Injury(AKI)
Acronym Furosemide for AKI
Scientific Title Double blind study of furosemide for Acute Kidney Injury(AKI)
Scientific Title:Acronym Furosemide for AKI
Region
Japan

Condition
Condition Acute Kidney Injury
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of furosemide for Acute Kidney Injury
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Renal function for 30 days since Acute Kidney Injury was recognized
Key secondary outcomes Duration of ICU stay, Duration of hospital stay, usage of RRT

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Normal saline 0.2ml/kg/h for placebo group will be administered for first 6 hours since AKI is recognized. When urine amount is gained over 3ml/kg/h, the drug is reduced by 0.05ml/kg/h with every 2 hours. When urine amount is not over 1ml/kg/h for 6 hours after the drug administration is started, Furosemide (2mg/ml) is administered with 0.2ml/kg/h for both groups and ordinal intervention is started. As any time rule to prevent dehydration, when urine amount is over 3ml/kg, linger solution administration is started with 0.5ml x urine amount (ml/h). CRTN level and urine amount is evaluated everyday for first 10 days and furosemide administration is continued until CRTN level change is under 0.05mg/dl. CRRT intervention is allowed as needed. Duration of observation is first 10 days since started and 30 days later.
Interventions/Control_2 Furosemide (2mg/ml) as 0.2ml/kg/h for AKI group will be administered for first 6 hours since AKI is recognized. When urine amount is gained over 3ml/kg/h, the drug is reduced by 0.05ml/kg/h with every 2 hours. When urine amount is not over 1ml/kg/h for 6 hours after drug administration is started, Furosemide (2mg/ml) is administered with 0.2ml/kg/h for both groups and ordinal intervention is started. As any time rule to prevent dehydration, when urine amount is over 3ml/kg, linger solution administration is started with 0.5ml x urine amount (ml/h). CRTN level and urine amount is evaluated everyday for first 10 days and furosemide administration is continued until CRTN level change is under 0.05mg/dl. CRRT intervention is allowed as needed. Duration of observation is first 10 days since started and 30 days later.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ICU patients and KDIGO AKI score more than one
Key exclusion criteria Patients on hemodiafiltration
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masao
Middle name
Last name Hayashi
Organization Kawasaki medical school general medical center
Division name Anesthesiology and Intensive care medicine 3
Zip code 700-8505
Address 2-6-1 Nakasange Kita-ku, Okayama
TEL 086-225-2111
Email mao893@aol.com

Public contact
Name of contact person
1st name Masao
Middle name
Last name Hayashi
Organization Kawasaki medical school general medical center
Division name Anesthesiology and Intensive care medicine 3
Zip code 700-8505
Address 2-6-1 Nakasange Kita-ku, Okayama
TEL 086-225-2111
Homepage URL
Email mao893@aol.com

Sponsor
Institute Kawasaki medical school general medical center
Institute
Department

Funding Source
Organization Kawasaki medical school general medical center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kawasaki medical school internal review board
Address 577 Matsushima Kurashiki, Okayama
Tel 086-464-1076
Email kmsrec@med.kawasaki-m.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
2021 Year 12 Month 01 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
2021 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2022 Year 12 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
2021 Year 11 Month 17 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052612

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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