Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
NCT04032600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2020-12-08
Summary
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.
Conditions
- Malignant Ascites
- Ovarian Cancer
- Hemodynamic Instability
Interventions
- PROCEDURE
-
Paracentesis
Full versus partial paracentesis (3 liters)
Sponsors & Collaborators
-
Charite University, Berlin, Germany
lead OTHER
Principal Investigators
-
Klaus Pietzner, MD · Charite-University Medicine of Berlin, Department of Gynecology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-01
- Primary Completion
- 2019-08-09
- Completion
- 2019-09-09
Countries
- Germany
Study Locations
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