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临床试验/NCT04032600
NCT04032600已完成不适用

Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Change of stroke volume

研究概览

简要总结

The ATLANTIS-study was designed to determine the safety of a full paracentesis in patients with malignant ascites due to ovarian cancer. The underlying hypothesis states, that full paracentesis does not impair safety, compared to fractioned paracentesis with clamping of the drain. Half of the patients will receive a full paracentesis, while the other half will receive fractioned paracentesis with clamping of the drain after 3 liters of ascites was evacuated. All patients receive extensive monitoring of hemodynamics and kidney function.

详细描述

Background: Malignant ascites is common in ovarian cancer and often causes symptoms such as abdominal pressure and shortness of breath, resulting in an decreased quality of life for the patient. Paracentesis is a safe and easy method for symptom relief. But no guidelines exist on the management of ascites drainage in ovarian cancer. In many cases a partial paracentesis is performed, due to fear of hemodynamic instability or kidney failure, with partial drainage of the intraperitoneal fluid on the first day and subsequent drainage on the next day. As there is no study that reported a deteriorated health due to full paracentesis in ovarian cancer, the decision whether a partial or total paracentesis is performed depends entirely on the department or the physician.

Since a total paracentesis can be performed as an out-patient treatment, this approach is often preferred by the patient. Full paracentesis is also more efficient and cost-effective.

The objective of the ATLANTIS-study is to prove the safety of total paracentesis regarding hemodynamic changes and kidney failure.

Methods: ATLANTIS is a randomized, prospective, clinical study that aims to include 60 patients. Patients with histologically confirmed epithelial ovarian, fallopian tube and peritoneal cancer are randomized into two arms: Partial (3 Liter) and total paracentesis. Before, during and for two hours after the paracentesis, an advanced hemodynamic monitoring is performed to ensure the patients' safety. The monitoring includes mean arterial pressure and stroke volume. After the initial phase of extensive monitoring (2 hours), the blood pressure is measured for a period of 24 hours to evaluate not only short term, but also long-term hemodynamic changes. Before and 24 hours after the paracentesis, blood samples are analyzed to detect a potential acute kidney failure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change of stroke volume

时间窗: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes

Stroke volume is measured by advanced hemodynamic monitoring

Change of mean arterial pressure

时间窗: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes

Mean arterial pressure is measured by advanced hemodynamic monitoring

次要结局

  • Quality of life- pre and post paracentesis: EQ-5D questionnaire(2 hours before paracentesis, 24 hours after paracentesis and 1 week after paracentesis)
  • Change of stroke volume in the post-paracentesis interval(2 hours after the finish of the paracentesis)
  • Incidence of side effects in the post-paracentesis interval(24 hours after the finish of the paracentesis)
  • Change of mean arterial pressure in the post-paracentesis interval(2 hours after the finish of the paracentesis)
  • Ascites related symptoms- pre and post paracentesis(2 hs before paracentesis, 24-hours after paracentesis and 1 week after paracentesis)
  • Incidence of symptoms in the post-paracentesis interval(24 hours after the finish of the paracentesis)
  • Change of laboratory values(Serial measurements: 2 hours prior to paracentesis, 24 hours after paracentesis)
  • Measurement of exact drainage volume(Within 1 hour after the finish of paracentesis)
  • VEGF (vascular endothelial growth factor) level(Within 1 hour after the finish of paracentesis)
  • Urine excretion(24 hours after the finish of paracentesis)
  • Change of venous return and mean systemic filling pressure(20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Klaus Pietzner

Principal Investigator, Consultant of Gynaecological Oncology

Charite University, Berlin, Germany

研究点 (2)

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