UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046093 |
|---|---|
| Receipt number | 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 11:19:59 |
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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
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
mao893@aol.com
Sponsor or person
Institute
Kawasaki medical school general medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052612
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