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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name