JPRN-jRCTs061220114招募中1 期
Efficacy and safety of tolvaptan for patients with ascites after liver resection, prospective study (Efficacy and safety of tolvaptan after liver resection, prospective study)
Ohdan Hideki0 个研究点目标入组 30 人开始时间: 2023年3月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
已完成
不适用
Efficacy and safety of tolvaptan on patients with severe chronic kidney disease complicated by congestive heart failuresevere chronic kidney disease complicated by congestive heart failureJPRN-UMIN000029787Department of Nephrology, Nippon Medical School50
招募中
不适用
Efficacy and safety of tolvaptan in patients with severe aortic stenosis and chronic kidney disease undergoing transcatheter aortic valve replacementJPRN-UMIN000033577Tokyo Women's Medical University40
招募中
不适用
Efficasy and safety of tolvaptan in patients undergoing peritoneal dialysis with heart failure despite the standard treatment with conventionalJPRN-UMIN000008712Division of Kidney and Hypertension, the Jikei University School of Medicine40
招募中
不适用
A Study of efficacy of Tolvaptan for Patients with Chronic Heart Failurechronic heart failureJPRN-UMIN000009897Department of Medicine II, Kansai Medical University,20
已完成
不适用
Study of the safety and efficacy of tolvaptan for fluid retention symptoms of right heart failure due to pulmonary hypertensiopulmonary hypertensionJPRN-UMIN000010196Department of Cardiology, Keio University School of Medicine40