Efficacy and safety of tolvaptan for patients with ascites after liver resection, prospective study(Efficacy and safety of tolvaptan after liver resection, prospective study)

JRCT ID: jRCTs061220114

Registered date:31/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Liver tumor
• Date of first enrollment: 22/06/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): The Administration of tolvaptan 7.5 mg will be started on the second day after the hepatectomy for patients with ascites drainage of 5 ml / BW kg or more on the first day after the operation.

Outcome(s)

• Primary Outcome: Maximum perioperative weight change

Secondary Outcome

volume of drainage
abdominal girth
Urine volume
Postoperative complication rate (heart failure, resp
iratory failure rate)
The days required for the weight that increased aft
er the operation decreasing to a value in preopera
tion
postoperative pleural effusion
Total dose of albumin, total dose of FFP
Type and amount of diuretic drug
Postoperative hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients eligible for the study were required to me
et all the following criteria
(1) underwent hepatectomy for liver diseases
(2) aged 18 years or more
(3) Performance Status (PS) of the Eastern Cooper
ative Oncology Group (ECOG) is 0-1
(4) the functions of major organs (bone marrow, liv
er, lungs, kidneys, etc.).
A) White blood cell count: 2,000 / mm3 or more
B) Amount of hemoglobin: 7.0 g / dL or more
C) Platelet count: 30,000 / mm3 or more
D) Total bilirubin: less than 5.0 mg / dL
E) Creatinine: less than 2.0 mg / dl
(5) Patients who have sufficient judgment to understand the content of the research and have given their written consent to participate in this study.
(6) a drainage's volume of 5 ml / BW 1 kg / day or more on the first day after surgery

Exclude criteria

Primary Screening
(1) Patients who have been taking tolvaptan (brand name: SAMSCA) preoperatively.
(2) Patients with a history of serious drug hypersensitivity or hypersensitivity to any component of tolvaptan or similar compounds.
(3) Patients with no thirst or difficulty in fluid intake, anuria, or hepatic encephalopathy who have difficulty in adequate hydration.
(4) Pregnant women or women who may be pregnant
(5) Patients with severe (NYHA classification III or higher) ischemic heart disease or severe valvular heart disease.
(6) Patients with severe hepatic cirrhosis (hepatic impairment degree C).
(7) Patients with renal dysfunction (Cre>2.0) and hyperkalemia (K>5.5).
(8) Patients with dyspnea requiring oxygen administration due to severe respiratory impairment (Hugh-Jones classification IV or higher), interstitial pneumonia or pulmonary fibrosis.
(9) Patients with serious preoperative complications such as infection or gastrointestinal bleeding.
(10) Patients who require complicated resection of other organs other than the gallbladder, gastrointestinal anastomosis, biliary reconstruction, lymph node dissection, or revascularization.
(11) Patients with psychosis or psychiatric symptoms that make participation in the study difficult.
(12) Other patients who are deemed inappropriate to participate in the study by the principal investigator or subinvestigators.
Secondary Screening
(13)Patients who do not feel thirst or have difficulty with fluid intake, anuric patients, or patients with hepatic encephalopathy who have difficulty with adequate hydration.
(14) Patients who required complicated resection of other organs other than the gallbladder, gastrointestinal anastomosis, biliary reconstruction, lymph node dissection, or revascularization.
(15) Patients with serious postoperative complications such as infection or gastrointestinal bleeding.
(16) Other patients who are deemed inappropriate for the study by the principal investigator or a subinvestigator.

Related Information

• Primary Sponsor: Ohdan Hideki