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

NCT04032600 | Completed

• 1 other identifier: EA 1/224/16
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Ascites; Ovarian Cancer; Hemodynamic Instability

Outcome Measures

Primary Outcomes (2)

• Change of stroke volume

  Stroke volume is measured by advanced hemodynamic monitoring

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

• Change of mean arterial pressure

  Mean arterial pressure is measured by advanced hemodynamic monitoring

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

Secondary Outcomes (11)

• Incidence of side effects in the post-paracentesis interval

  24 hours after the finish of the paracentesis

• Incidence of symptoms in the post-paracentesis interval

  24 hours after the finish of the paracentesis

• Change of stroke volume in the post-paracentesis interval

  2 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

• Change of laboratory values

  Serial measurements: 2 hours prior to paracentesis, 24 hours after paracentesis

Study Arms (2)

Full paracentesis

OTHER

All ascites is drained

Procedure: Paracentesis

Fractioned paracentesis

OTHER

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

Procedure: Paracentesis

Interventions

Paracentesis PROCEDURE

Full versus partial paracentesis (3 liters)

Fractioned paracentesis; Full paracentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Klaus Pietzner, MD

  Charite-University Medicine of Berlin, Department of Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant of Gynaecological Oncology

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: July 25, 2019
• Study Start: August 1, 2017
• Primary Completion: August 9, 2019
• Study Completion: September 9, 2019
• Last Updated: December 8, 2020

Record last verified: 2019-07

Locations

DE (1)