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The safety and effectiveness of tolvaptan in primary carcinoma of liver edema patients after undergoing partial hepatectomy

The safety and effectiveness of tolvaptan in primary carcinoma of liver edema patients after undergoing partial hepatectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011846
Enrollment
Unknown
Registered
2017-07-03
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-07-10

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

Conditions

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Interventions

Tolvaptan group:tolvaptan 15mg, once daily, for 3 days
Control group:spironolactone 100mg, furosemide 40mg, once daily, for 3 days

Sponsors

Tianjin First Centre Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18-65 years; 2. Primary carcinoma of liver edema patients after undergoing partial hepatectomy; 3. Patients are with?hyponatremia after surgery within 48hours, the definition of hyponatremia is serum sodium level 25; 6. Patients are able to understand the purpose of the study and can sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Meet specification of tolvaptan contraindications 2. Patients with the following diseases, comorbidities or symptoms: Acute /chronic aortic dissection patients; active myocarditis or amyloid cardiomyopathy; suspected circulating blood volume reduction, obstructive hypertrophic cardiomyopathy, poorly controlled diabetes, fasting glucose higher than 220 mg/dl (or 12.21 mmol/l); dysuria urethral stricture, calculus and tumor induced by; 3. Patients with shock and persistent bacterial infection before surgery; 4. Patients with hypoalbuminemia; 5. Patients with hepatic encephalopathy or hepatorenal syndrome; 6. Patients with gastrointestinal bleeding history within 10 days and doctors diagnose the patients with gastrointestinal bleeding risk; 7. Pregnancy test positive patients; 8. Abuse of alcohol or drugs or patients who are participating in other clinical trials; 9. The investigators consider that patients are not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
abdominal circumference;B-ultrasound;drainage tube extubation time;body weight;

Countries

China

Contacts

Public ContactZhang Yamin

Tianjin First Centre Hospital

zhangyamin@medmail.com.cn+86 13802122219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026