Liver CirrhosisNCT02975726
Peritoneal Dialysis Catheters for the Treatment of Refractory Ascites
A study testing Peritoneal Dialysis Catheter, Large Volume Paracentesis and 25% Human Serum Albumin injection in people with Liver Cirrhosis and Ascites, run by University of Manitoba at 1 site in Canada.
Trial summary
One complication of liver disease is the buildup of fluid within the belly. This is known as ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of breath. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Ascites
- What is being tested?
- Peritoneal Dialysis Catheter, Large Volume Paracentesis and 25% Human Serum Albumin injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Feb 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
- Males and non-pregnant females greater than 18 years of age.
- Liver cirrhosis as defined by a histological, clinical, or radiological criteria
- Patients with refractory non-malignant ascites requiring 2 or more LVPs in the last 4 months.
- No contraindication for bedside PD catheter insertion (e.g. prior major abdominal surgery, ostomies, large hernias, bleeding diatheses, inability to lie flat).
- Patients having a support person (family member/friend/caregiver, etc) willing to go through training and help with catheter care.
Who cannot join
- Prior liver transplant
- Is actively being worked up for liver transplant or is already on the liver transplant waitlist
- Current SBP (spontaneous bacterial peritonitis) defined as polymorphonuclear (PMN) cell count of >250 cells/mm3 in the ascites or positive bacteria in ascitic cultures
- Malignant ascites
- Severe coagulopathy with either an INR (international normalized ratio) > 1.5, a platelet count < 50 x 109/L that is not able to be reversed at time of PD catheter insertion
- Any previous episodes of spontaneous bacterial peritonitis.
Show all 13Show fewer
- Loculated ascites
- Known presence of HIV/AIDS
- Immunomodulatory treatments used within the last 4 months
- Expected survival <6 months and/or MELD (The Model for End-Stage Liver Disease) score > 30
- Hepatic Encephalopathy episode requiring hospital admission in the past 6 months.
- History of non-compliance or suspected failure to comply with study requirements
- Allergies to Vancomycin and Cephalosporins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peritoneal Dialysis Catheters for the Treatment of Refractory Ascites Management: A Randomized Un-Blinded Pilot Study
One complication of liver disease is the buildup of fluid within the belly. This is known as ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of breath. Ascites is typically treated with medications, however when that does not work, patients need a procedure where a needle is inserted in the belly every few weeks to drain the excess fluid. About 2 in 5 patients with ascites from liver failure can get kidney disease from their worsening liver function or from the drainage of fluid with needles. Once patients have both advanced liver disease and kidney disease, their chance of dying largely increases.
The present study will be the first of its kind to study a new technique to treat ascites. Investigators are planning to place a tube in a patient's belly to drain the excessive amounts of fluid. This technique is similar to how one type of dialysis is done to treat patients with kidney failure. This study is set as a pilot investigation in order to determine the feasibility of doing a larger, randomized clinical trial investigating the use of this novel technique. Importantly, advanced liver disease patients are at high risk to develop kidney disease, and therefore are an important group to focus on. Investigators believe that this technique will prevent or slow the development of kidney disease in liver failure patients, and improve their quality of life, far more than the current available treatments.
Read the detailed description
Refractory ascites is when fluid recurrently accumulates in the peritoneal cavity, as an end result of multiple mechanisms, including liver cirrhosis, peritoneal infiltration by tumor, portal hypertension, lymphangitic carcinomatosis, congestive heart failure, or lymphatic obstruction. It is associated with increased mortality and morbidity, including complications of abdominal wall hernias, spontaneous bacterial peritonitis, kidney dysfunction, and pleural effusions. The development of ascites also leads to multiple symptoms including anorexia, early satiety, nausea and vomiting, shortness of breath, and limited mobility.
The management of ascites associated with liver dysfunction usually follows a stepwise escalation in treatments. The initial management typically involves sodium restriction and diuretic therapy up to a daily maximum of 160 mg of furosemide and 400 mg of spironolactone. When ascites no longer can be controlled by these measures, one option is to decrease portal hypertension, a main pathogenic factor in ascites development, by undergoing a procedure called transjugular intrahepatic portosystemic shunt (TIPS). This procedure requires certain patient criteria to be fulfilled and is associated with complications and increased risk of hepatic encephalopathy, and therefore is confined to a small subgroup of patients with ascites. Consequently, abdominal large volume paracentesis (LVP) is the treatment of choice in many patients. This procedure involves insertion of a needle into the peritoneal cavity where ascites accumulates, then attaching the needle to a collection system that drains the ascites by gravity. The definitive treatment for ascites in patients with cirrhosis is a liver transplant, but due to limited supply of organs, and contraindications to transplantation, patients often undergo repeated LVP while waiting on the wait list or until death. Paracentesis is associated with risks including post paracentesis circulatory dysfunction leading to hyponatremia, kidney dysfunction, viscus puncture, and peritonitis. It also is a costly, resource intense, and at times an uncomfortable treatment for patients due to the procedure itself and the need for repeated treatments.
A potential alternative to LVP is the placement of an intraperitoneal catheter, in the same manner that a peritoneal dialysis (PD) catheter, to drain ascites. The procedure has a high technical insertion success rate with minimal complications and is routinely done at the bedside by nephrologist under local anesthesia. PD catheter placement for ascites drainage has many potential advantages, including the ability for it to be done at home by the patient and avoid visits to clinics or hospitals; the frequency of drainage can be timed to patient symptoms, and perhaps have less complication rates than LVP. However, the efficacy and safety of this approach in decompensated cirrhosis when compared to periodic LVP (current standard of care) has not been tested in a randomized trial. Investigators propose a single center, multi-site randomized control trial comparing bedside PD catheter placement versus usual standard of serial LVP for treatment of refractory ascites. The primary outcomes will be improvement of 10 points in the physical component score (PCS) of the Short Form-36 (SF-36) at two months. Investigators plan to randomize 50 patients (25 per arm) based on a power calculation to achieve an 10 point improvement in the PCS-SF-36 (SE = 5). Secondary outcomes will include incidence of mechanical and infectious complications, emergency department utilization, hospitalization and mortality, all other domains of the SF-36, Euroquol-5D (EQ-5D), the Newcastle Patient Reported Ascites Measure and overall health care costs.
Primary Hypothesis: Drainage of ascites associated with liver failure via PD catheter is superior to serial LVP in improving the physical component of quality of life as measured by SF-36.
This trial will be pivotal in possibly changing the standard of care for the management of refractory ascites from cirrhosis. If the primary hypothesis is confirmed, investigators will design and conduct subsequent trials to address potential morbidity and mortality benefits associated with this technique for ascites management.
- Conditions
- Liver Cirrhosis, Ascites
- Being tested
- Peritoneal Dialysis Catheter, Large Volume Paracentesis, 25% Human Serum Albumin injection, Bloodwork
- Keywords
- Liver Cirrhosis, Refractory ascites, PD catheter
- Medical subject headings
- Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal Dialysis CatheterDevice
Peritoneal dialysis catheter insertion in order to drain access fluid within the belly for patients with liver cirrhosis and refractory ascites.
Large Volume ParacentesisProcedure or surgery
Insertion of a needle into the peritoneal cavity where ascites accumulates, then attaching the needle to a collection system that drains the ascites by gravity. This procedure is part of the standard care for the treatment of refractory ascites.
25% Human Serum Albumin injectionBiological
Patients will be given Human Serum Albumin after the initial drain of ascites fluid: 100cc for 5-10L drainage, 200cc for 10-15L drainage.
BloodworkProcedure or surgery
Monthly bloodwork will be done as part of usual standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal Dialysis Catheter Insertion | Experimental | Catheters will be inserted at the bedside in a special procedure room.Argyle PD catheter kits will be used:2 cuffed curled catheters at 57cm or 62cm lengths. At time of PD catheter insertion,most patients will be drained of 5-10L of ascites or more to decrease the chance of catheter leaks.The volume removed will be at sole discretion of physician doing the procedure.Patients will be administered 25% Human Serum Albumin injection: 100cc after the 5-10L drainage,and 200cc if 10-15L is removed.Patients will undergo an initial drain and training with a specialized nurse.Patients in this arm will be instructed to drain a maximum of 2L per day after the initial drain.Monthly bloodwork will be performed. Receives: Device: Peritoneal Dialysis Catheter; Biological: 25% Human Serum Albumin injection; Procedure: Bloodwork |
| Large Volume Paracentesis | Active comparator | Patients in this arm of the study will continue their usual practice of LVP as required. They will continue to undergo their LVP procedures through their regular means.Monthly bloodwork will be performed. Receives: Procedure: Large Volume Paracentesis; Procedure: Bloodwork |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the physical component of Quality of Life
Change in the physical component summary score of the SF 36 questionnaire.
Measured: 2 months post intervention
Secondary outcomes (16)
Catheter Insertion Technical Success Rate
Technical success rate of tunneled PD catheters: Defined as successful positioning of the catheter in the intraperitoneal space with initial drainage of ascites
Measured: Day of insertion of PD catheter
PD Catheter Survival
Defined as days from insertion to date of a PD catheter related complication if they occur, assessed during the study timeframe.
Measured: Number of days between catheter insertion and possible complication, up to 6 months
PD Catheter Related Complications Frequency
The number of participants with following complications: 1) Infection at the exit site or tunnel (as defined by the International Society of peritoneal Dialysis 2010 guidelines). 2) Peritonitis 3) intra-luminal/extra-luminal obstruction 4) catheter mal positioning (migration, omental wrapping) 5) Catheter leakage
Measured: through study completion, up to 6 months
Large Volume Paracentesis Complications Frequency
The number of participants with following complications: 1) Peritonitis 2) leakage at puncture site 3) visceral puncture
Measured: through study completion, up to 6 months
Participant Self-Reported Health Status
Measured by the number of points as a result of participants' answers to SF-36 questionnaire
Measured: 0,2,4 and 6 months
Participant Health State Description and Evaluation
Measured by the number of points as a result of participants' answers to EQ-5D questionnaire
Measured: 0,2,4 and 6 months
The Impact of Ascites on Health Related Quality of Life
Measured by the number of points as a result of participants' answers to Newcastle Patient Reported Ascites Measure questionnaire
Measured: 0,2,4 and 6 months
Renal Dysfunction Assessment
Measured by blood work: serum creatinine, serum sodium, potassium, chloride, bicarbonate, urea, glucose, eGFR (estimated glomerular filtration rate).
Measured: Monthly, up to 6 months
Renal Function Assessment
Measured by 24 hour urine collection: creatinine clearance, urine volume and urine sodium.
Measured: at 0 and 6 months
Serum Albumin and PD Fluid Albumin Assesment
PD catheter arm: Assessment of serum albumin and measurement of albumin in PD fluid at 0, 2, and 6 months
Measured: At 0, 2, and 6 months
Patient Heart Rate
Patient heart rate taken as part of regular physical assessment
Measured: At regular clinic appointments, through study completion, up to 6 months
Patient Blood Pressure
Patient blood pressure taken as part of regular physical assessment
Measured: At regular clinic appointments, through study completion, up to 6 months
Patient Weight
Patient weight taken as part of regular physical assessment
Measured: At regular clinic appointments, through study completion, up to 6 months
Hospital Visits
The number of hospital admissions or emergency department visits from complications related to cirrhosis (encephalopathy, gastrointestinal bleed) or peritonitis.
Measured: through study completion, up to 6 months
Total Health Care Costs
Direct health care costs will be estimated for both groups of patients taking a health care payor perspective.
Measured: through study completion, up to 6 months
Cost Effectiveness
A decision analysis, Markov model will be constructed between the two intervention arms with outcomes expressed as cost per quality adjusted live year (cost per QALY) and expressed as incremental cost effectiveness ratios (ICER's).
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Komenda, University of Manitoba
- Investigators
- Paul Komenda, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975726
- Sponsor's protocol ID
- B2014:066
- Status last verified
- Apr 2021
- First submitted
- 22 Nov 2016
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Senousy BE, Draganov PV. Evaluation and management of patients with refractory ascites. World J Gastroenterol. 2009 Jan 7;15(1):67-80. doi: 10.3748/wjg.15.67.
PubMed 19115470Planas R, Montoliu S, Balleste B, Rivera M, Miquel M, Masnou H, Galeras JA, Gimenez MD, Santos J, Cirera I, Morillas RM, Coll S, Sola R. Natural history of patients hospitalized for management of cirrhotic ascites. Clin Gastroenterol Hepatol. 2006 Nov;4(11):1385-94. doi: 10.1016/j.cgh.2006.08.007.
PubMed 17081806Singhal S, Baikati KK, Jabbour II, Anand S. Management of refractory ascites. Am J Ther. 2012 Mar;19(2):121-32. doi: 10.1097/MJT.0b013e3181ff7a8b.
PubMed 21192246Runyon BA; AASLD Practice Guidelines Committee. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009 Jun;49(6):2087-107. doi: 10.1002/hep.22853. No abstract available.
PubMed 19475696Van Thiel DH, Moore CM, Garcia M, George M, Nadir A. Continuous peritoneal drainage of large-volume ascites. Dig Dis Sci. 2011 Sep;56(9):2723-7. doi: 10.1007/s10620-011-1792-x. Epub 2011 Jul 7.
PubMed 21735084Peltekian KM, Wong F, Liu PP, Logan AG, Sherman M, Blendis LM. Cardiovascular, renal, and neurohumoral responses to single large-volume paracentesis in patients with cirrhosis and diuretic-resistant ascites. Am J Gastroenterol. 1997 Mar;92(3):394-9.
PubMed 9068457Lungren MP, Kim CY, Stewart JK, Smith TP, Miller MJ. Tunneled peritoneal drainage catheter placement for refractory ascites: single-center experience in 188 patients. J Vasc Interv Radiol. 2013 Sep;24(9):1303-8. doi: 10.1016/j.jvir.2013.05.042. Epub 2013 Jul 19.
PubMed 23876552Savin MA, Kirsch MJ, Romano WJ, Wang SK, Arpasi PJ, Mazon CD. Peritoneal ports for treatment of intractable ascites. J Vasc Interv Radiol. 2005 Mar;16(3):363-8. doi: 10.1097/01.RVI.0000147082.05392.2B.
PubMed 15758132Tapping CR, Ling L, Razack A. PleurX drain use in the management of malignant ascites: safety, complications, long-term patency and factors predictive of success. Br J Radiol. 2012 May;85(1013):623-8. doi: 10.1259/bjr/24538524. Epub 2011 Mar 22.
PubMed 21427184Barnett TD, Rubins J. Placement of a permanent tunneled peritoneal drainage catheter for palliation of malignant ascites: a simplified percutaneous approach. J Vasc Interv Radiol. 2002 Apr;13(4):379-83. doi: 10.1016/s1051-0443(07)61740-0.
PubMed 11932368Belfort MA, Stevens PJ, DeHaek K, Soeters R, Krige JE. A new approach to the management of malignant ascites; a permanently implanted abdominal drain. Eur J Surg Oncol. 1990 Feb;16(1):47-53.
PubMed 1689678Monsky WL, Yoneda KY, MacMillan J, Deutsch LS, Dong P, Hourigan H, Schwartz Y, Magee S, Duffield C, Boak T, Cernilia J. Peritoneal and pleural ports for management of refractory ascites and pleural effusions: assessment of impact on patient quality of life and hospice/home nursing care. J Palliat Med. 2009 Sep;12(9):811-7. doi: 10.1089/jpm.2009.0061.
PubMed 19622018Fleming ND, Alvarez-Secord A, Von Gruenigen V, Miller MJ, Abernethy AP. Indwelling catheters for the management of refractory malignant ascites: a systematic literature overview and retrospective chart review. J Pain Symptom Manage. 2009 Sep;38(3):341-9. doi: 10.1016/j.jpainsymman.2008.09.008. Epub 2009 Mar 28.
PubMed 19328648Nessim SJ, Bargman JM, Jassal SV, Oliver MJ, Na Y, Perl J. The impact of transfer from hemodialysis on peritoneal dialysis technique survival. Perit Dial Int. 2015 May-Jun;35(3):297-305. doi: 10.3747/pdi.2013.00147. Epub 2013 Dec 1.
PubMed 24293665Wong F. Management of ascites in cirrhosis. J Gastroenterol Hepatol. 2012 Jan;27(1):11-20. doi: 10.1111/j.1440-1746.2011.06925.x.
PubMed 21916992
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal Dialysis Catheters for the Treatment of Refractory Ascites Management: A Randomized Un-Blinded Pilot Study
- ClinicalTrials.gov ID
- NCT02975726
- Acronym / sponsor ID
- B2014:066
- Conditions
- Liver Cirrhosis, Ascites
- Keywords
- Liver Cirrhosis, Refractory ascites, PD catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 29 Nov 2016 (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.
One complication of liver disease is the buildup of fluid within the belly. This is known as ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of breath. Ascites is typically treated with medications, however when that does not work, patients need a procedure where a needle is inserted in the belly every few weeks to drain the excess fluid. About 2 in 5 patients with ascites from liver failure can get kidney disease from their worsening liver function or from the drainage of fluid with needles. Once patients have both advanced liver disease and kidney disease, their chance of dying largely increases.
The present study will be the first of its kind to study a new technique to treat ascites. Investigators are planning to place a tube in a patient's belly to drain the excessive amounts of fluid. This technique is similar to how one type of dialysis is done to treat patients with kidney failure. This study is set as a pilot investigation in order to determine the feasibility of doing a larger, randomized clinical trial investigating the use of this novel technique. Importantly, advanced liver disease patients are at high risk to develop kidney disease, and therefore are an important group to focus on. Investigators believe that this technique will prevent or slow the development of kidney disease in liver failure patients, and improve their quality of life, far more than the current available treatments.
Detailed description
Refractory ascites is when fluid recurrently accumulates in the peritoneal cavity, as an end result of multiple mechanisms, including liver cirrhosis, peritoneal infiltration by tumor, portal hypertension, lymphangitic carcinomatosis, congestive heart failure, or lymphatic obstruction. It is associated with increased mortality and morbidity, including complications of abdominal wall hernias, spontaneous bacterial peritonitis, kidney dysfunction, and pleural effusions. The development of ascites also leads to multiple symptoms including anorexia, early satiety, nausea and vomiting, shortness of breath, and limited mobility.
The management of ascites associated with liver dysfunction usually follows a stepwise escalation in treatments. The initial management typically involves sodium restriction and diuretic therapy up to a daily maximum of 160 mg of furosemide and 400 mg of spironolactone. When ascites no longer can be controlled by these measures, one option is to decrease portal hypertension, a main pathogenic factor in ascites development, by undergoing a procedure called transjugular intrahepatic portosystemic shunt (TIPS). This procedure requires certain patient criteria to be fulfilled and is associated with complications and increased risk of hepatic encephalopathy, and therefore is confined to a small subgroup of patients with ascites. Consequently, abdominal large volume paracentesis (LVP) is the treatment of choice in many patients. This procedure involves insertion of a needle into the peritoneal cavity where ascites accumulates, then attaching the needle to a collection system that drains the ascites by gravity. The definitive treatment for ascites in patients with cirrhosis is a liver transplant, but due to limited supply of organs, and contraindications to transplantation, patients often undergo repeated LVP while waiting on the wait list or until death. Paracentesis is associated with risks including post paracentesis circulatory dysfunction leading to hyponatremia, kidney dysfunction, viscus puncture, and peritonitis. It also is a costly, resource intense, and at times an uncomfortable treatment for patients due to the procedure itself and the need for repeated treatments.
A potential alternative to LVP is the placement of an intraperitoneal catheter, in the same manner that a peritoneal dialysis (PD) catheter, to drain ascites. The procedure has a high technical insertion success rate with minimal complications and is routinely done at the bedside by nephrologist under local anesthesia. PD catheter placement for ascites drainage has many potential advantages, including the ability for it to be done at home by the patient and avoid visits to clinics or hospitals; the frequency of drainage can be timed to patient symptoms, and perhaps have less complication rates than LVP. However, the efficacy and safety of this approach in decompensated cirrhosis when compared to periodic LVP (current standard of care) has not been tested in a randomized trial. Investigators propose a single center, multi-site randomized control trial comparing bedside PD catheter placement versus usual standard of serial LVP for treatment of refractory ascites. The primary outcomes will be improvement of 10 points in the physical component score (PCS) of the Short Form-36 (SF-36) at two months. Investigators plan to randomize 50 patients (25 per arm) based on a power calculation to achieve an 10 point improvement in the PCS-SF-36 (SE = 5). Secondary outcomes will include incidence of mechanical and infectious complications, emergency department utilization, hospitalization and mortality, all other domains of the SF-36, Euroquol-5D (EQ-5D), the Newcastle Patient Reported Ascites Measure and overall health care costs.
Primary Hypothesis: Drainage of ascites associated with liver failure via PD catheter is superior to serial LVP in improving the physical component of quality of life as measured by SF-36.
This trial will be pivotal in possibly changing the standard of care for the management of refractory ascites from cirrhosis. If the primary hypothesis is confirmed, investigators will design and conduct subsequent trials to address potential morbidity and mortality benefits associated with this technique for ascites management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal Dialysis Catheter Insertion | Experimental | Device: Peritoneal Dialysis Catheter, Biological: 25% Human Serum Albumin injection, Procedure: BloodworkCatheters will be inserted at the bedside in a special procedure room.Argyle PD catheter kits will be used:2 cuffed curled catheters at 57cm or 62cm lengths. At time of PD catheter insertion,most patients will be drained of 5-10L of ascites or more to decrease the chance of catheter leaks.The volume removed will be at sole discretion of physician doing the procedure.Patients will be administered 25% Human Serum Albumin injection: 100cc after the 5-10L drainage,and 200cc if 10-15L is removed.Patients will undergo an initial drain and training with a specialized nurse.Patients in this arm will be instructed to drain a maximum of 2L per day after the initial drain.Monthly bloodwork will be performed. |
| Large Volume Paracentesis | Active comparator | Procedure: Large Volume Paracentesis, Procedure: BloodworkPatients in this arm of the study will continue their usual practice of LVP as required. They will continue to undergo their LVP procedures through their regular means.Monthly bloodwork will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and non-pregnant females greater than 18 years of age.
- Liver cirrhosis as defined by a histological, clinical, or radiological criteria
- Patients with refractory non-malignant ascites requiring 2 or more LVPs in the last 4 months.
- No contraindication for bedside PD catheter insertion (e.g. prior major abdominal surgery, ostomies, large hernias, bleeding diatheses, inability to lie flat).
- Patients having a support person (family member/friend/caregiver, etc) willing to go through training and help with catheter care.
Key exclusion criteria (13 listed)
- Prior liver transplant
- Is actively being worked up for liver transplant or is already on the liver transplant waitlist
- Current SBP (spontaneous bacterial peritonitis) defined as polymorphonuclear (PMN) cell count of >250 cells/mm3 in the ascites or positive bacteria in ascitic cultures
- Malignant ascites
- Severe coagulopathy with either an INR (international normalized ratio) > 1.5, a platelet count < 50 x 109/L that is not able to be reversed at time of PD catheter insertion
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 |
|---|---|---|
| Peritoneal Dialysis CatheterPeritoneal dialysis catheter insertion in order to drain access fluid within the belly for patients with liver cirrhosis and refractory ascites. | Device | Peritoneal Dialysis Catheter Insertion |
| Large Volume ParacentesisInsertion of a needle into the peritoneal cavity where ascites accumulates, then attaching the needle to a collection system that drains the ascites by gravity. This procedure is part of the standard care for the treatment of refractory ascites. | Procedure or surgery | Large Volume Paracentesis |
| 25% Human Serum Albumin injectionPatients will be given Human Serum Albumin after the initial drain of ascites fluid: 100cc for 5-10L drainage, 200cc for 10-15L drainage. | Biological | Peritoneal Dialysis Catheter Insertion |
| BloodworkMonthly bloodwork will be done as part of usual standard of care. | Procedure or surgery | Large Volume Paracentesis, Peritoneal Dialysis Catheter Insertion |
Primary outcome
Change in the physical component of Quality of Life
Time frame: 2 months post intervention
Change in the physical component summary score of the SF 36 questionnaire.
16 secondary outcomes
Catheter Insertion Technical Success Rate
Time frame: Day of insertion of PD catheter
PD Catheter Survival
Time frame: Number of days between catheter insertion and possible complication, up to 6 months
PD Catheter Related Complications Frequency
Time frame: through study completion, up to 6 months
Large Volume Paracentesis Complications Frequency
Time frame: through study completion, up to 6 months
Participant Self-Reported Health Status
Time frame: 0,2,4 and 6 months
Participant Health State Description and Evaluation
Time frame: 0,2,4 and 6 months
The Impact of Ascites on Health Related Quality of Life
Time frame: 0,2,4 and 6 months
Renal Dysfunction Assessment
Time frame: Monthly, up to 6 months
Renal Function Assessment
Time frame: at 0 and 6 months
Serum Albumin and PD Fluid Albumin Assesment
Time frame: At 0, 2, and 6 months
Patient Heart Rate
Time frame: At regular clinic appointments, through study completion, up to 6 months
Patient Blood Pressure
Time frame: At regular clinic appointments, through study completion, up to 6 months
Patient Weight
Time frame: At regular clinic appointments, through study completion, up to 6 months
Hospital Visits
Time frame: through study completion, up to 6 months
Total Health Care Costs
Time frame: through study completion, up to 6 months
Cost Effectiveness
Time frame: through study completion, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Background: PubMed 19115470Senousy BE, Draganov PV. Evaluation and management of patients with refractory ascites. World J Gastroenterol. 2009 Jan 7;15(1):67-80. doi: 10.3748/wjg.15.67.
- Background: PubMed 17081806Planas R, Montoliu S, Balleste B, Rivera M, Miquel M, Masnou H, Galeras JA, Gimenez MD, Santos J, Cirera I, Morillas RM, Coll S, Sola R. Natural history of patients hospitalized for management of cirrhotic ascites. Clin Gastroenterol Hepatol. 2006 Nov;4(11):1385-94. doi: 10.1016/j.cgh.2006.08.007.
- Background: PubMed 21192246Singhal S, Baikati KK, Jabbour II, Anand S. Management of refractory ascites. Am J Ther. 2012 Mar;19(2):121-32. doi: 10.1097/MJT.0b013e3181ff7a8b.
- Background: PubMed 19475696Runyon BA; AASLD Practice Guidelines Committee. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009 Jun;49(6):2087-107. doi: 10.1002/hep.22853. No abstract available.
- Background: PubMed 21735084Van Thiel DH, Moore CM, Garcia M, George M, Nadir A. Continuous peritoneal drainage of large-volume ascites. Dig Dis Sci. 2011 Sep;56(9):2723-7. doi: 10.1007/s10620-011-1792-x. Epub 2011 Jul 7.
- Background: PubMed 9068457Peltekian KM, Wong F, Liu PP, Logan AG, Sherman M, Blendis LM. Cardiovascular, renal, and neurohumoral responses to single large-volume paracentesis in patients with cirrhosis and diuretic-resistant ascites. Am J Gastroenterol. 1997 Mar;92(3):394-9.
- Background: PubMed 23876552Lungren MP, Kim CY, Stewart JK, Smith TP, Miller MJ. Tunneled peritoneal drainage catheter placement for refractory ascites: single-center experience in 188 patients. J Vasc Interv Radiol. 2013 Sep;24(9):1303-8. doi: 10.1016/j.jvir.2013.05.042. Epub 2013 Jul 19.
- Background: PubMed 15758132Savin MA, Kirsch MJ, Romano WJ, Wang SK, Arpasi PJ, Mazon CD. Peritoneal ports for treatment of intractable ascites. J Vasc Interv Radiol. 2005 Mar;16(3):363-8. doi: 10.1097/01.RVI.0000147082.05392.2B.
- Background: PubMed 21427184Tapping CR, Ling L, Razack A. PleurX drain use in the management of malignant ascites: safety, complications, long-term patency and factors predictive of success. Br J Radiol. 2012 May;85(1013):623-8. doi: 10.1259/bjr/24538524. Epub 2011 Mar 22.
- Background: PubMed 11932368Barnett TD, Rubins J. Placement of a permanent tunneled peritoneal drainage catheter for palliation of malignant ascites: a simplified percutaneous approach. J Vasc Interv Radiol. 2002 Apr;13(4):379-83. doi: 10.1016/s1051-0443(07)61740-0.
- Background: PubMed 1689678Belfort MA, Stevens PJ, DeHaek K, Soeters R, Krige JE. A new approach to the management of malignant ascites; a permanently implanted abdominal drain. Eur J Surg Oncol. 1990 Feb;16(1):47-53.
- Background: PubMed 19622018Monsky WL, Yoneda KY, MacMillan J, Deutsch LS, Dong P, Hourigan H, Schwartz Y, Magee S, Duffield C, Boak T, Cernilia J. Peritoneal and pleural ports for management of refractory ascites and pleural effusions: assessment of impact on patient quality of life and hospice/home nursing care. J Palliat Med. 2009 Sep;12(9):811-7. doi: 10.1089/jpm.2009.0061.
- Individual participant dataSharing planned: No
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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.
Paul Komenda, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal Dialysis Catheter, Large Volume Paracentesis and 25% Human Serum Albumin injection in people with Liver Cirrhosis and Ascites, run by University of Manitoba at 1 site in Canada.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 22 Apr 2021. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the physical component of Quality of Life (time frame: 2 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975726, which also lists 15 linked publications.
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 22 Apr 2021.