Peritoneal Dialysis Catheters for the Treatment of Refractory Ascites

NCT02975726 | Completed DMC

• 1 other identifier: B2014:066
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Cirrhosis; Ascites

Keywords

Liver Cirrhosis; Refractory ascites; PD catheter

Outcome Measures

Primary Outcomes (1)

• Change in the physical component of Quality of Life

  Change in the physical component summary score of the SF 36 questionnaire.

  2 months post intervention

Secondary Outcomes (16)

• Catheter Insertion Technical Success Rate

  Day of insertion of PD catheter

• PD Catheter Survival

  Number of days between catheter insertion and possible complication, up to 6 months

• PD Catheter Related Complications Frequency

  through study completion, up to 6 months

• Large Volume Paracentesis Complications Frequency

  through study completion, up to 6 months

• Participant Self-Reported Health Status

  0,2,4 and 6 months

Study Arms (2)

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.

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.

Procedure: Large Volume Paracentesis; Procedure: Bloodwork

Interventions

Peritoneal Dialysis Catheter DEVICE

Peritoneal dialysis catheter insertion in order to drain access fluid within the belly for patients with liver cirrhosis and refractory ascites.

Peritoneal Dialysis Catheter Insertion

Large Volume Paracentesis PROCEDURE

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.

Large Volume Paracentesis

25% Human Serum Albumin injection BIOLOGICAL

Patients will be given Human Serum Albumin after the initial drain of ascites fluid: 100cc for 5-10L drainage, 200cc for 10-15L drainage.

Peritoneal Dialysis Catheter Insertion

Bloodwork PROCEDURE

Monthly bloodwork will be done as part of usual standard of care.

Large Volume Paracentesis; Peritoneal Dialysis Catheter Insertion

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Publications (15)

• 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.

  PMID: 19115470 BACKGROUND

• Planas 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.

  PMID: 17081806 BACKGROUND

• Singhal 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.

  PMID: 21192246 BACKGROUND

• Runyon 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.

  PMID: 19475696 BACKGROUND

• Van 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.

  PMID: 21735084 BACKGROUND

• Peltekian 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.

  PMID: 9068457 BACKGROUND

• Lungren 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.

  PMID: 23876552 BACKGROUND

• Savin 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.

  PMID: 15758132 BACKGROUND

• Tapping 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.

  PMID: 21427184 BACKGROUND

• Barnett 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.

  PMID: 11932368 BACKGROUND

• Belfort 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.

  PMID: 1689678 BACKGROUND

• Monsky 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.

  PMID: 19622018 BACKGROUND

• Fleming 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.

  PMID: 19328648 BACKGROUND

• Nessim 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.

  PMID: 24293665 BACKGROUND

• Wong F. Management of ascites in cirrhosis. J Gastroenterol Hepatol. 2012 Jan;27(1):11-20. doi: 10.1111/j.1440-1746.2011.06925.x.

  PMID: 21916992 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Ascites

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Paul Komenda, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: February 1, 2019
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)