CirrhosisPETRANCT03027635
PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis
A study testing PleurX, peritoneal tunnelated catheter, Large Volume Paracentesis and Ciprofloxacin 500Mg Tablet in people with Cirrhosis and Ascites Hepatic, run by Nina Kimer at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Ascites Hepatic, Ascites (Non-Malignant)
- What is being tested?
- PleurX, peritoneal tunnelated catheter, Large Volume Paracentesis and Ciprofloxacin 500Mg Tablet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jan 2017to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis of any aetiology
- Diuretic resistant ascites defined as i) an inability to mobilise ascites (minimal or no weight loss) despite administration with the maximum tolerable doses of oral diuretics or a daily dose of spironolactone 400 mg and re-accumulation of fluid after therapeutic paracentesis within two weeks or ii) diuretic-related complications including (but not limited to) azotemia, hepatic encephalopathy, or progressive electrolyte imbalances
- Able to read and understand Danish
- Signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female of any age
- Age at least 18 years
- Expected survival at least three months.
Who cannot join
- Participants eligible and listed for TIPS
- Serum creatinine levels above 135 umol/L
- Overt hepatic encephalopathy in the two weeks before randomization
- Ascites due to other causes than cirrhosis such as: malignant disease, congestive heart failure, end-stage renal disease, pancreatitis, or Budd-Chiari (hepatic vein thrombosis), or chylous ascites
- Ongoing intra-abdominal infection (peritonitis) or active systemic or local infections, such as urinary tract infection or pneumonia
- Participation in a clinical study that may interfere with participation in this study;
Show all 12Show fewer
- Evidence of extensive ascites loculation
- Coagulopathy
- Variceal bleeding within two weeks before randomisation
- Intraabdominal surgery within four months before randomisation
- Spontaneous bacterial peritonitis (neutrophil count>250/µl within 24 hours of randomization)
- Patients with an increased risk of procedure related complications as judged by the primary healthcare provider
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gastro Unit, medical Division, University Hospital Hvidovre
Hvidovre, Danmark, 2650
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Cirrhosis, Ascites Hepatic, Ascites (Non-Malignant)
- Being tested
- PleurX, peritoneal tunnelated catheter, Large Volume Paracentesis, Ciprofloxacin 500Mg Tablet
- Keywords
- diuretic resistant ascites, Paracentesis, PleurX, Peritoneal tunnelated catheter
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PleurX, peritoneal tunnelated catheterDevice
A permanent catheter
Large Volume ParacentesisDevice
Short time drainage
Ciprofloxacin 500Mg TabletDrug
SBP prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| PleurX | Experimental | 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. Receives: Device: PleurX, peritoneal tunnelated catheter; Drug: Ciprofloxacin 500Mg Tablet |
| Large Volume Paracentesis | Active comparator | 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. Receives: Device: Large Volume Paracentesis; Drug: Ciprofloxacin 500Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first paracentesis
Measured: 18 months
Secondary outcomes (4)
Adverse events
Number of AEs in groups
Measured: 18 months
Nutritional Status
Indirect calorimetry
Measured: 18 months
Renal function
glomerular filtration rate
Measured: 18 months
Cardiac Output
cardiac output
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start20 Jan 2017
- Primary completion15 May 2019
- Study completion15 May 2019
Why it stopped: Slow recruitment and limited funding. The treatment intervention is instituted in clinical practice as and end-stage treatment option at hospitals in Denmark
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nina Kimer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nina Kimer, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027635
- Sponsor's protocol ID
- PETRA21042016
- Acronym
- PETRA
- Status last verified
- May 2019
- First submitted
- 13 Dec 2016
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to Danish Legislation only anonymized data may be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03027635
- Acronym / sponsor ID
- PETRA / PETRA21042016
- Conditions
- Cirrhosis, Ascites Hepatic, Ascites (Non-Malignant)
- Keywords
- diuretic resistant ascites, Paracentesis, PleurX, Peritoneal tunnelated catheter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment and limited funding. The treatment intervention is instituted in clinical practice as and end-stage treatment option at hospitals in Denmark
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nina KimerUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PleurX | Experimental | Device: PleurX, peritoneal tunnelated catheter, Drug: Ciprofloxacin 500Mg TabletThe 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. |
| Large Volume Paracentesis | Active comparator | Device: Large Volume Paracentesis, Drug: Ciprofloxacin 500Mg TabletLarge 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cirrhosis of any aetiology
- Diuretic resistant ascites defined as i) an inability to mobilise ascites (minimal or no weight loss) despite administration with the maximum tolerable doses of oral diuretics or a daily dose of spironolactone 400 mg and re-accumulation of fluid after therapeutic paracentesis within two weeks or ii) diuretic-related complications including (but not limited to) azotemia, hepatic encephalopathy, or progressive electrolyte imbalances
- Able to read and understand Danish
- Signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (12 listed)
- Participants eligible and listed for TIPS
- Serum creatinine levels above 135 umol/L
- Overt hepatic encephalopathy in the two weeks before randomization
- Ascites due to other causes than cirrhosis such as: malignant disease, congestive heart failure, end-stage renal disease, pancreatitis, or Budd-Chiari (hepatic vein thrombosis), or chylous ascites
- Ongoing intra-abdominal infection (peritonitis) or active systemic or local infections, such as urinary tract infection or pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PleurX, peritoneal tunnelated catheterA permanent catheter | Device | PleurX |
| Large Volume ParacentesisShort time drainage | Device | Large Volume Paracentesis |
| Ciprofloxacin 500Mg TabletSBP prophylaxis | Drug | Large Volume Paracentesis, PleurX |
Primary outcome
Time to first paracentesis
Time frame: 18 months
4 secondary outcomes
Adverse events
Time frame: 18 months
Nutritional Status
Time frame: 18 months
Renal function
Time frame: 18 months
Cardiac Output
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Slow recruitment and limited funding. The treatment intervention is instituted in clinical practice as and end-stage treatment option at hospitals in Denmark). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Individual participant dataSharing planned: Undecided. Due to Danish Legislation only anonymized data may be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PleurX, peritoneal tunnelated catheter, Large Volume Paracentesis and Ciprofloxacin 500Mg Tablet in people with Cirrhosis and Ascites Hepatic, run by Nina Kimer at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment and limited funding. The treatment intervention is instituted in clinical practice as and end-stage treatment option at hospitals in Denmark). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first paracentesis (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.