<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03027635</url>
  </required_header>
  <id_info>
    <org_study_id>PETRA21042016</org_study_id>
    <nct_id>NCT03027635</nct_id>
  </id_info>
  <brief_title>PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis</brief_title>
  <acronym>PETRA</acronym>
  <official_title>Tunnelated Peritoneal Catheter Versus Repeated Large Volume Paracentesis for Diuretic Resistant Ascites in Patients With Cirrhosis: An Investigator Initiated, Open, Parallel Arm Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nina Kimer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Copenhagen University Hospital, Hvidovre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small&#xD;
      volume fluid drainage at home. The treatment may improve the management of ascites and have a&#xD;
      beneficial effect on the quality of life.&#xD;
&#xD;
      This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter&#xD;
      (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic&#xD;
      resistant ascites.&#xD;
&#xD;
      The trial is an investigator initiated, randomised, single blind, parallel arm, controlled&#xD;
      trial.&#xD;
&#xD;
      Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will&#xD;
      receive ciprofloxacin to prevent spontaneous bacterial peritonitis.&#xD;
&#xD;
      We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total&#xD;
      duration of follow up is six months. The primary outcome is paracentesis free survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ten percent of patients with cirrhosis develop ascites. In 90% of patients, ascites can be&#xD;
      treated with diuretics. The management of the remaining 10% with diuretic resistant ascites&#xD;
      is challenging. Symptoms including abdominal pain, dyspnoea, nausea, vomiting, and anorexia&#xD;
      have a detrimental impact on the quality of life. Repeated large volume paracentesis provides&#xD;
      only temporary improvement of symptoms.&#xD;
&#xD;
      Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small&#xD;
      volume fluid drainage at home. The treatment may improve the management of ascites and have a&#xD;
      beneficial effect on the quality of life.&#xD;
&#xD;
      To evaluate the beneficial and harmful effects of the peritoneal catheter (PleurX) versus&#xD;
      repeated large volume paracentesis for patients with cirrhosis and diuretic resistant&#xD;
      ascites.&#xD;
&#xD;
      Investigator initiated, randomised, single blind, parallel arm, controlled trial.&#xD;
&#xD;
      Due to the nature of the intervention and the primary outcome measure, Investigators are&#xD;
      unable to conduct the trial with blinding of the patients, the investigators or use blinded&#xD;
      outcome assessment.&#xD;
&#xD;
      Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will&#xD;
      receive ciprofloxacin to prevent spontaneous bacterial peritonitis.&#xD;
&#xD;
      The study investigators will include 32 adult patients with cirrhosis of any aetiology and&#xD;
      diuretic resistant ascites.&#xD;
&#xD;
      Gastrounit, Hvidovre University Hospital, Department of Gastroenterology and Hepatology,&#xD;
      Odense University Hospital, Department of Gastroenterology and Hepatology, Aarhus University&#xD;
      Hospital, and Centre for Hepatology, UCL Institute for Liver and Digestive Health, Royal Free&#xD;
      Campus, University College London, UK 18 months. The total duration of follow up is six&#xD;
      months. The primary outcome is paracentesis free survival. Secondary outcomes include&#xD;
      cumulative number of paracentesis, cirrhosis-related complications, safety, quality of life,&#xD;
      changes in metabolic and nutritional parameters, circulatory dysfunction, renal function,&#xD;
      cardiac output, neuro-humoral changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow recruitment and limited funding. The treatment intervention is instituted in clinical&#xD;
    practice as and end-stage treatment option at hospitals in Denmark&#xD;
  </why_stopped>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first paracentesis</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>18 months</time_frame>
    <description>Number of AEs in groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional Status</measure>
    <time_frame>18 months</time_frame>
    <description>Indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>18 months</time_frame>
    <description>glomerular filtration rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Output</measure>
    <time_frame>18 months</time_frame>
    <description>cardiac output</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Cirrhosis</condition>
  <condition>Ascites Hepatic</condition>
  <condition>Ascites (Non-Malignant)</condition>
  <arm_group>
    <arm_group_label>PleurX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The PleurX catheter is a tunnelated peritoneal catheter, designed for permanent placement in the peritoneal cavity. The catheter is placed by a physician under sterile conditions. Drainage of ascites is done using vacuum bottles connected to the catheter. This can be managed by a home nurse or the patient.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Large Volume Paracentesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Large volume paracentesis is performed in sterile technique, a small incision is made through the skin, and a catheter is inserted through muscle and peritoneum. After the procedure, the patient remains in hospital for observation until the fluid is drained.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PleurX, peritoneal tunnelated catheter</intervention_name>
    <description>A permanent catheter</description>
    <arm_group_label>PleurX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Large Volume Paracentesis</intervention_name>
    <description>Short time drainage</description>
    <arm_group_label>Large Volume Paracentesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciprofloxacin 500Mg Tablet</intervention_name>
    <description>SBP prophylaxis</description>
    <arm_group_label>Large Volume Paracentesis</arm_group_label>
    <arm_group_label>PleurX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cirrhosis of any aetiology&#xD;
&#xD;
          -  Diuretic resistant ascites defined as i) an inability to mobilise ascites (minimal or&#xD;
             no weight loss) despite administration with the maximum tolerable doses of oral&#xD;
             diuretics or a daily dose of spironolactone 400 mg and re-accumulation of fluid after&#xD;
             therapeutic paracentesis within two weeks or ii) diuretic-related complications&#xD;
             including (but not limited to) azotemia, hepatic encephalopathy, or progressive&#xD;
             electrolyte imbalances&#xD;
&#xD;
          -  Able to read and understand Danish&#xD;
&#xD;
          -  Signed and dated informed consent form&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Male or female of any age&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Expected survival at least three months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants eligible and listed for TIPS&#xD;
&#xD;
          -  Serum creatinine levels above 135 umol/L&#xD;
&#xD;
          -  Overt hepatic encephalopathy in the two weeks before randomization&#xD;
&#xD;
          -  Ascites due to other causes than cirrhosis such as: malignant disease, congestive&#xD;
             heart failure, end-stage renal disease, pancreatitis, or Budd-Chiari (hepatic vein&#xD;
             thrombosis), or chylous ascites&#xD;
&#xD;
          -  Ongoing intra-abdominal infection (peritonitis) or active systemic or local&#xD;
             infections, such as urinary tract infection or pneumonia&#xD;
&#xD;
          -  Participation in a clinical study that may interfere with participation in this study;&#xD;
&#xD;
          -  Evidence of extensive ascites loculation&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Variceal bleeding within two weeks before randomisation&#xD;
&#xD;
          -  Intraabdominal surgery within four months before randomisation&#xD;
&#xD;
          -  Spontaneous bacterial peritonitis (neutrophil count&gt;250/µl within 24 hours of&#xD;
             randomization)&#xD;
&#xD;
          -  Patients with an increased risk of procedure related complications as judged by the&#xD;
             primary healthcare provider&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gastro Unit, medical Division, University Hospital Hvidovre</name>
      <address>
        <city>Hvidovre</city>
        <state>Danmark</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 16, 2019</last_update_submitted>
  <last_update_submitted_qc>May 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
    <investigator_full_name>Nina Kimer</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>diuretic resistant ascites</keyword>
  <keyword>Paracentesis</keyword>
  <keyword>PleurX</keyword>
  <keyword>Peritoneal tunnelated catheter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
    <mesh_term>Ascites</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciprofloxacin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Due to Danish Legislation only anonymized data may be available upon request</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03027635
org study id: PETRA21042016
nct id: NCT03027635
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small
      volume fluid drainage at home. The treatment may improve the management of ascites and have a
      beneficial effect on the quality of life.

      This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter
      (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic
      resistant ascites.

      The trial is an investigator initiated, randomised, single blind, parallel arm, controlled
      trial.

      Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will
      receive ciprofloxacin to prevent spontaneous bacterial peritonitis.

      We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total
      duration of follow up is six months. The primary outcome is paracentesis free survival.
Ten percent of patients with cirrhosis develop ascites. In 90% of patients, ascites can be
      treated with diuretics. The management of the remaining 10% with diuretic resistant ascites
      is challenging. Symptoms including abdominal pain, dyspnoea, nausea, vomiting, and anorexia
      have a detrimental impact on the quality of life. Repeated large volume paracentesis provides
      only temporary improvement of symptoms.

      Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small
      volume fluid drainage at home. The treatment may improve the management of ascites and have a
      beneficial effect on the quality of life.

      To evaluate the beneficial and harmful effects of the peritoneal catheter (PleurX) versus
      repeated large volume paracentesis for patients with cirrhosis and diuretic resistant
      ascites.

      Investigator initiated, randomised, single blind, parallel arm, controlled trial.

      Due to the nature of the intervention and the primary outcome measure, Investigators are
      unable to conduct the trial with blinding of the patients, the investigators or use blinded
      outcome assessment.

      Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will
      receive ciprofloxacin to prevent spontaneous bacterial peritonitis.

      The study investigators will include 32 adult patients with cirrhosis of any aetiology and
      diuretic resistant ascites.

      Gastrounit, Hvidovre University Hospital, Department of Gastroenterology and Hepatology,
      Odense University Hospital, Department of Gastroenterology and Hepatology, Aarhus University
      Hospital, and Centre for Hepatology, UCL Institute for Liver and Digestive Health, Royal Free
      Campus, University College London, UK 18 months. The total duration of follow up is six
      months. The primary outcome is paracentesis free survival. Secondary outcomes include
      cumulative number of paracentesis, cirrhosis-related complications, safety, quality of life,
      changes in metabolic and nutritional parameters, circulatory dysfunction, renal function,
      cardiac output, neuro-humoral changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Time to first paracentesis
time frame: 18 months
measure: Adverse events
time frame: 18 months
description: Number of AEs in groups
measure: Nutritional Status
time frame: 18 months
description: Indirect calorimetry
measure: Renal function
time frame: 18 months
description: glomerular filtration rate
measure: Cardiac Output
time frame: 18 months
description: cardiac output
arm group label: PleurX
arm group type: Experimental
description: The PleurX catheter is a tunnelated peritoneal catheter, designed for permanent placement in the peritoneal cavity. The catheter is placed by a physician under sterile conditions. Drainage of ascites is done using vacuum bottles connected to the catheter. This can be managed by a home nurse or the patient.
arm group label: Large Volume Paracentesis
arm group type: Active Comparator
description: Large volume paracentesis is performed in sterile technique, a small incision is made through the skin, and a catheter is inserted through muscle and peritoneum. After the procedure, the patient remains in hospital for observation until the fluid is drained.
intervention type: Device
intervention name: PleurX, peritoneal tunnelated catheter
description: A permanent catheter
arm group label: PleurX
intervention type: Device
intervention name: Large Volume Paracentesis
description: Short time drainage
arm group label: Large Volume Paracentesis
intervention type: Drug
intervention name: Ciprofloxacin 500Mg Tablet
description: SBP prophylaxis
arm group label: Large Volume Paracentesis
arm group label: PleurX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Copenhagen University Hospital, Hvidovre
investigator full name: Nina Kimer
investigator title: MD, PhD
mesh term: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Ascites
mesh term: Ciprofloxacin
sharing ipd: Undecided
ipd description: Due to Danish Legislation only anonymized data may be available upon request