UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective cohort analysis of the factor related to the effect of tolvaptan on the medium-and-long term prognosis in patients with hepatic edema
Acronym	clinical trial of tolvaptan for hepatic edema
Scientific Title	Retrospective cohort analysis of the factor related to the effect of tolvaptan on the medium-and-long term prognosis in patients with hepatic edema
Scientific Title:Acronym	clinical trial of tolvaptan for hepatic edema
Region	Japan

Condition
Condition	hepatic edema
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate influence that tolvaptan for hepatic edema will give the prognosis of the cirrhotic patient, and intend that I clarify optimum time of the introduction of tolvaptan by clarifying the patient baseline factor which influenced the prognosis of the cirrhotic patient under tolvaptan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the survival days of the cirrhotic patientunder tolvaptan
Key secondary outcomes

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)Age 20 years old or older 2)The patient that an own strength walk is possible 3)The patient who can list in an interview vote by oneself 4)the patient that agree the participation to this 5)The patient who meets the following clinical inspection standards a) A hemoglobin level: >= 8.0 g/dl b) A neutrophilic number: >= 1,000/mm3 c) The number of the platelets: >= 30,000/mm3 e) ALT and AST level: 6 times of the <= facilities standard
Key exclusion criteria	1) The patient who has an applicable heart trouble as follows a) Congestive heart failures more than NYHA class 3 b) The high blood pressure that it is poor in control 2) Dangerously ill patient (except HBV, the HCV) who and has an infectious disease of the activity 3) Patient with a history of the HIV infection 4) Patient during hemodialysis 6) Patient of hepatic encephalopathy having difficulty in appropriate hydration 7) The patient who was treated whom patient 8) who produced the gastrointestinal tract bleeding that a blood transfusion and measures need within four weeks before this study start corresponds below to a) Whole body chemotherapy within four weeks before this study start b) The patient who has difficulty in 9 operation) drug remedy under the general anesthesia within four weeks before this study start 10) When may spoil the security of the patient in 13 patient) others affecting the evaluation of this study entry and result, this study enforcement or when the observance of this study enforcement plan is judged with difficulty by 12 patient) drug abuse that may wake up an allergic reaction for possibility of during a pregnant woman, the nursing and the pregnancy or this patient 11) study drug with the intention
Target sample size	400

Research contact person
Name of lead principal investigator	1st name IWASHITA Middle name Last name AI
Organization	NIPPON MEDICAL SCHOOL HOSPITAL
Division name	gastroenterology
Zip code	113-0022
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3824-2332
Email	a0520i@nms.ac.jp

Public contact
Name of contact person	1st name IWASHITA Middle name Last name AI
Organization	NIPPON MEDICAL SCHOOL HOSPITAL
Division name	gastroenterology
Zip code	113-0022
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3824-2332
Homepage URL
Email	a0520i@nms.ac.jp

Sponsor
Institute	NIPPON MEDICAL SCHOOL HOSPITAL
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NIPPON MEDICAL SCHOOL HOSPITAL
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel	03-3824-2332
Email	a0520i@nms.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	2019 Year 05 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	No longer recruiting
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2019 Year 06 Month 01 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2019 Year 07 Month 30 Day
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information	none

Management information
Registered date	2019 Year 04 Month 24 Day
Last modified on	2020 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041681