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Retrospective cohort analysis of the factor related to the effect of tolvaptan on the medium-and-long term prognosis in patients with hepatic edema

Retrospective cohort analysis of the factor related to the effect of tolvaptan on the medium-and-long term prognosis in patients with hepatic edema - clinical trial of tolvaptan for hepatic edema

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000036589
Enrollment
400
Registered
2019-05-01
Start date
2019-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatic edema

Interventions

None listed

Sponsors

NIPPON MEDICAL SCHOOL HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
the survival days of the cirrhotic patientunder tolvaptan

Countries

Japan

Contacts

Public ContactIWASHITA AI

NIPPON MEDICAL SCHOOL HOSPITAL gastroenterology

a0520i@nms.ac.jp03-3824-2332

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026