UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040179 |
|---|---|
| Receipt number | R000045809 |
| Scientific Title | Examination of the effects on renal function and prognosis of various diuretics for liver cirrhosis |
| Date of disclosure of the study information | 2020/04/17 |
| Last modified on | 2020/04/16 17:04:20 |
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Basic information
Public title
Examination of the effects on renal function and prognosis of various diuretics for liver cirrhosis
Acronym
Diuretics and renal function / prognosis in liver cirrhosis
Scientific Title
Examination of the effects on renal function and prognosis of various diuretics for liver cirrhosis
Scientific Title:Acronym
Diuretics and renal function / prognosis in liver cirrhosis
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of effects of various diuretics on renal function and prognosis in patients with fluid retention associated with liver cirrhosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre-treatment AKI marker (urinary L-FABP, urine NGAL) values and changes in renal dysfunction up to 12 months after starting diuretics (eGFR, creatinine, cystatin C)
Key secondary outcomes
1 Prognosis after starting diuretics
2 Changes in AKI markers and renal function by diuretics type (eGFR, creatinine, cystatin C)
3 Prognosis according to the type of diuretics
4 Changes in diuretic dose and renal function (eGFR, creatinine, cystatin C)
5 Relationship between inflammatory response (CRP) levels and prognosis
6 Relationship between soluble CD14 value and prognosis
7 recurrence rate of fluid retention after diuretics administration
8 Relationship between water retention recurrence after diuretic administration and various blood chemistry and urine tests
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1 Patients with liver cirrhosis who have accumulated fluid such as ascites, pleural effusion, or edema, and who have been administered diuretics or have been administered.
2 Regarding the study subjects who will newly collect samples, patients who received a sufficient explanation before participating in this study, and with sufficient understanding, obtained the written consent of the study subjects themselves.
3 Regarding research subjects whose specimens have already been stored for the purpose of research, those who have obtained free consent to participate in this research or who do not refuse to participate in the research
Key exclusion criteria
1 Those who have a history of hypersensitivity to the components of diuretics
2 People who have difficulty taking the drug
3 Those who cannot drink water
4 Unurinated person
5 Pregnant women or women who may be pregnant
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | MASATO |
| Middle name | |
| Last name | NAKAI |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
060-8648
Address
kita-14,nishi-5, kita-ku,Sapporo
TEL
011-716-1161
mnakai@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Nakai |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
0608638
Address
Kita-15, Nishi-7, Kita-ku
TEL
+81117161161
Homepage URL
mnakai@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
None
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita-15, Nishi-7, Kita-ku
Tel
0117067636
crjimu@huhp.hokudai.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 | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 04 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045809
