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

Primary Purpose

Malignant Ascites, Ovarian Cancer, Hemodynamic Instability

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Paracentesis
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Ascites

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • Histologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer
  • Symptomatic (e.g. abdominal pressure, pain, shortness of breath) malignant ascites with clinical indication for paracentesis and sonographic estimate of >3 liters
  • Patient information and written informed consent

Exclusion criteria:

  • Age <18 years
  • Missing written informed consent
  • Lack of sufficient knowledge of german or english language
  • No willingness to consent to the storage or distribution of anonymised disease-specific data inside the clinical trial
  • Placement inside a state facility due to judicial order
  • Employee status at Charite-University Medicine of Berlin
  • Chronic kidney insufficiency defined as serum creatinin levels >1,2 g/dl at time point of admission
  • Active neurologic/psychiatric disorder at time point of admission
  • Cardiac insufficiency defined as >NYHA I at time point of admission
  • Manifest ileus at time point of admission
  • Manifest chronic arterial hypo- or hypertension, defined as chronic baseline systolic pressure of <90 or >140 mmHg and diastolic pressure of <70 and >90 mmHg
  • Active infection
  • Blood clotting disorder (congenital or acquired)
  • Thrombocytopenia (platelets <80 000/nl)
  • Active participation in another clinical intervention trial at time point of admission
  • Chronic atrial fibrillation on time point of admission
  • Status post cardiac pacer implantation
  • Liver cirrhosis
  • Liver metastases

Sites / Locations

  • Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Full paracentesis

Fractioned paracentesis

Arm Description

All ascites is drained

3 Liters are drained, then the drain is clamped and the rest of the ascites is drained on the next day

Outcomes

Primary Outcome Measures

Change of stroke volume
Stroke volume is measured by advanced hemodynamic monitoring
Change of mean arterial pressure
Mean arterial pressure is measured by advanced hemodynamic monitoring

Secondary Outcome Measures

Incidence of side effects in the post-paracentesis interval
Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)
Incidence of symptoms in the post-paracentesis interval
Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)
Change of stroke volume in the post-paracentesis interval
Stroke volume is measured by advanced hemodynamic monitoring
Change of mean arterial pressure in the post-paracentesis interval
Mean arterial pressure is measured by advanced hemodynamic monitoring
Change of laboratory values
Measurement in plasma (Blood count, creatinin, AST, ALT, urea, aldosterone, renin, sodium, potassium, albumin, C-reactive protein, leukocytes)
Urine excretion
Urin volume
Quality of life- pre and post paracentesis: EQ-5D questionnaire
Measured with the EuroQuol-Group 5 Dimensions - Visual analog scale (EQ-5D VAS) questionnaire, the questionnaire directs to characterize the quality of life by mobility, activities, pain and fear and subjective scale between 1 (worst) and 100 (best)
Ascites related symptoms- pre and post paracentesis
Measured with the and Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI) questionnaire, the questionnaire directs to characterise the symptoms associated to ascites regarding 13 factors e.g. appetite, sleep, activities, symptoms, emotional distress by 0 to 4 points. The maximum score is 52 (best result: 13x4), 0 is the minimum score (worst result 13x0)
Measurement of exact drainage volume
Measurement of exact drainage volume in millilitre
VEGF (vascular endothelial growth factor) level
Measurement of the concentration of hormone vascular endothelial growth factor in ascites
Change of venous return and mean systemic filling pressure
Venous return and mean systemic filling pressure is measured by advanced hemodynamic monitoring

Full Information

First Posted
February 11, 2018
Last Updated
December 6, 2020
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04032600
Brief Title
Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
Acronym
ATLANTIS
Official Title
Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 9, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Ascites, Ovarian Cancer, Hemodynamic Instability

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full paracentesis
Arm Type
Other
Arm Description
All ascites is drained
Arm Title
Fractioned paracentesis
Arm Type
Other
Arm Description
3 Liters are drained, then the drain is clamped and the rest of the ascites is drained on the next day
Intervention Type
Procedure
Intervention Name(s)
Paracentesis
Intervention Description
Full versus partial paracentesis (3 liters)
Primary Outcome Measure Information:
Title
Change of stroke volume
Description
Stroke volume is measured by advanced hemodynamic monitoring
Time Frame
20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Title
Change of mean arterial pressure
Description
Mean arterial pressure is measured by advanced hemodynamic monitoring
Time Frame
20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Secondary Outcome Measure Information:
Title
Incidence of side effects in the post-paracentesis interval
Description
Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)
Time Frame
24 hours after the finish of the paracentesis
Title
Incidence of symptoms in the post-paracentesis interval
Description
Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)
Time Frame
24 hours after the finish of the paracentesis
Title
Change of stroke volume in the post-paracentesis interval
Description
Stroke volume is measured by advanced hemodynamic monitoring
Time Frame
2 hours after the finish of the paracentesis
Title
Change of mean arterial pressure in the post-paracentesis interval
Description
Mean arterial pressure is measured by advanced hemodynamic monitoring
Time Frame
2 hours after the finish of the paracentesis
Title
Change of laboratory values
Description
Measurement in plasma (Blood count, creatinin, AST, ALT, urea, aldosterone, renin, sodium, potassium, albumin, C-reactive protein, leukocytes)
Time Frame
Serial measurements: 2 hours prior to paracentesis, 24 hours after paracentesis
Title
Urine excretion
Description
Urin volume
Time Frame
24 hours after the finish of paracentesis
Title
Quality of life- pre and post paracentesis: EQ-5D questionnaire
Description
Measured with the EuroQuol-Group 5 Dimensions - Visual analog scale (EQ-5D VAS) questionnaire, the questionnaire directs to characterize the quality of life by mobility, activities, pain and fear and subjective scale between 1 (worst) and 100 (best)
Time Frame
2 hours before paracentesis, 24 hours after paracentesis and 1 week after paracentesis
Title
Ascites related symptoms- pre and post paracentesis
Description
Measured with the and Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI) questionnaire, the questionnaire directs to characterise the symptoms associated to ascites regarding 13 factors e.g. appetite, sleep, activities, symptoms, emotional distress by 0 to 4 points. The maximum score is 52 (best result: 13x4), 0 is the minimum score (worst result 13x0)
Time Frame
2 hs before paracentesis, 24-hours after paracentesis and 1 week after paracentesis
Title
Measurement of exact drainage volume
Description
Measurement of exact drainage volume in millilitre
Time Frame
Within 1 hour after the finish of paracentesis
Title
VEGF (vascular endothelial growth factor) level
Description
Measurement of the concentration of hormone vascular endothelial growth factor in ascites
Time Frame
Within 1 hour after the finish of paracentesis
Title
Change of venous return and mean systemic filling pressure
Description
Venous return and mean systemic filling pressure is measured by advanced hemodynamic monitoring
Time Frame
20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Histologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer Symptomatic (e.g. abdominal pressure, pain, shortness of breath) malignant ascites with clinical indication for paracentesis and sonographic estimate of >3 liters Patient information and written informed consent Exclusion criteria: Age <18 years Missing written informed consent Lack of sufficient knowledge of german or english language No willingness to consent to the storage or distribution of anonymised disease-specific data inside the clinical trial Placement inside a state facility due to judicial order Employee status at Charite-University Medicine of Berlin Chronic kidney insufficiency defined as serum creatinin levels >1,2 g/dl at time point of admission Active neurologic/psychiatric disorder at time point of admission Cardiac insufficiency defined as >NYHA I at time point of admission Manifest ileus at time point of admission Manifest chronic arterial hypo- or hypertension, defined as chronic baseline systolic pressure of <90 or >140 mmHg and diastolic pressure of <70 and >90 mmHg Active infection Blood clotting disorder (congenital or acquired) Thrombocytopenia (platelets <80 000/nl) Active participation in another clinical intervention trial at time point of admission Chronic atrial fibrillation on time point of admission Status post cardiac pacer implantation Liver cirrhosis Liver metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Pietzner, MD
Organizational Affiliation
Charite-University Medicine of Berlin, Department of Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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