Prospective Evaluation of PleurX Drain for Treatment of Cirrhotic Refractory Ascites

• ClinicalTrials.gov Identifier: NCT04569565
• Recruitment Status: Completed
• First Posted: September 30, 2020
• Last Update Posted: September 30, 2020
• Sponsor: University of Alberta
• Collaborator: Becton, Dickinson and Company
• Information provided by (Responsible Party): University of Alberta

Study Description

Brief Summary:

Refractory ascites (fluid build up in the abdomen that can not bet managed by medications) occurs in at least 10% of patients with end stage liver disease (cirrhosis). Two major options for management include large volume paracentesis (LVP)-drainage with a needle through the abdominal wall) and placement of a transjugular intrahepatic portosystemic shunt (TIPS)-re-directs blood flow across the cirrhotic liver), Not all patients are candidates for TIPS or transplant, are left with LVP as the only long-term treatment option. Patients listed for transplant require LVP while they wait for transplant.

LVP can cause pain, bleeding, leakage from the drain site and frequent hospital visits which result in health care cost as well as patient and caregiver fatigue. In between the drains, living with ascites can negatively affect quality of life because of discomfort and limitations. Patients with ascites are more malnourished than those without.

Specialized drains tunnelled under the skin, are used in patents with ascites due to cancer (malignant). There are not many studies evaluating these drains in patients with cirrhosis, One of the reasons for the lack of studies is the potential for infection. As opposed to malignant ascites, cirrhotic ascites generally has a low protein content, a risk factor for development of spontaneous bacterial peritonitis (SBP). From available studies, infection rates in cirrhotic patients with tunnelled drains who are not on antibiotics are estimated at 10% (4/40). Infection rates on antibiotic prophylaxis would be expected to be lower.

This pilot study includes the evaluation of indwelling tunnelled PleurX catheters as an alternative option. The hypothesis is that with careful monitoring of kidney function and prevention of infection with antibiotics, PleurX catheters will be safe, cost-effective and improve quality of life and nutritional status compared to the standard of care.

Condition or disease	Intervention/treatment	Phase
Ascites Hepatic	Device: PleurX catheter	Not Applicable

Detailed Description:

Ascites not manageable by diuretic therapy occurs in at least 10% of patients with cirrhosis. Two major options for management include intermittent large volume paracentesis (LVP) and placement of a transjugular intrahepatic portosystemic shunt (TIPS). Unfortunately, not all patients are candidates for TIPS. Those unable to receive TIPS or transplant are left with LVP as the only long-term treatment option. Non-TIPS candidates who are listed for transplant require LVP as a bridge to transplant.

LVP is performed by inserting a non-tunnelled drain, removing ascites fluid via, replacing ascites fluid losses >5 litres(L) with albumin, removing the drain. It can be associated with pain, bleeding, leakage from the site and frequent hospital visits. In between the drains, living with ascites can negatively affect quality of life, particularly the physical discomfort and limitation component scales. In addition, patients with tense ascites have lower protein intake and are more malnourished than those without. Fluid removal improves gastric accommodation.

Indwelling ascites drains are routinely used in patents with malignant ascites. Data evaluating indwelling drains in patients with cirrhosis is limited. One of the reasons that this may not have been explored as a therapeutic option is the potential for infection. As opposed to malignant ascites, cirrhotic ascites generally has a low protein content, a known risk factor for development of spontaneous bacterial peritonitis (SBP). From available data, infection rates in cirrhotic patients with tunnelled drains, not on antibiotic prophylaxis are estimated at 10%. Infection rates on antibiotic prophylaxis would be expected to be lower, but this remains unstudied. Other concerns particular to the patient with cirrhosis are renal dysfunction and acute kidney injury. Limitation of the amount of ascites that is drained to <5L per time and infusion of albumin 8grams(g)/L removed for amounts drained >5L has shown benefit in preventing post paracentesis circulatory and renal dysfunction.

Therefore, as some patients with cirrhosis will be left with intermittent LVP as their only option for management, and as this therapy has implications for quality of life (QOL), worsening nutritional status and cost, we propose an evaluation of an indwelling tunnelled PleurX catheter as an alternative therapeutic option. In this prospective uncontrolled pilot study, the hypothesis is that use of indwelling drains with careful monitoring of renal function and prophylaxis with antibiotics, will be safe, cost-effective and improve quality of life and nutritional status compared to the standard of care.

METHODS:

Study design: Prospective uncontrolled interventional pilot study of 12 patients followed for 3 months.

Recruitment: Patients will be recruited from Hepatology departments at the University of Alberta hospital (UAH) and Royal Alexandra hospital (RAH) in Edmonton. All Hepatologists at these sites will be informed of the protocol. If a patient meets inclusion and exclusion criteria and is interested in hearing more about the study, the Hepatologist can contact the study personnel. Patients will be made aware that their decision to participate in the study will not influence their medical care.

Study Intervention:

PleurX drain insertion by interventional radiologist

Outpatient drainage protocol:

Ascites fluid drainage performed at participant's home via home care nurse 1-3 times per week (maximum 3L- with each drain) for 3months. PleurX drain bottles will be used instead of urinary drainage bags

Safety Measures:

Home care nurses are trained in the use of PleurX drains. Patients will be taught and given information about complication monitoring.

Albumin infusion at 1g/kilogram(kg) as an outpatient when: the serum creatinine increases from baseline >26umol/L or by 1.5-2 times (Stage 1 Acute Kidney Injury), or the patient has clinical signs of hypovolemia Spontaneous bacterial peritonitis (SBP) prophylaxis with Norfloxacin 400mg daily Patient counselling on avoidance of non-steroidal anti-inflammatory drugs (NSAIDs), aminoglycosides, radiologic contrast, angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, angiotensin receptor blockers (ARBs) where possible

PROCEDURE & DATA COLLECTION:

Pre-Intervention (2 weeks prior to drain placement)

Continued standard of care LVP with albumin replacement, and recording of procedure related complications (shunt misplacement, insertion bleeding, pain-10 point scale) Pt to complete three-day food record (including 1 day pre-paracentesis, day of paracentesis, and 1 day post paracentesis), as well as Council on Nutrition appetite questionnaire (CNAQ, score range 8-40 where a lower score indicates more problems with appetite).

Nutritional assessment: Weight (kilograms), height (centimeters), calorie (kilocalories) and protein (grams) intake, mid-arm muscle circumference(centimeters), hand-grip strength by Jamar hand-grip dynamometer (kilograms) Labs pre-LVP including: urine electrolytes, serum complete blood cell (CBC) and differential, prothrombin time(PT), creatinine(Cr), electrolytes, alanine transaminase (ALT), aspartate transaminase (AST), Bilirubin, albumin, rennin, aldosterone

Quality of life and symptom questionnaires pre and post paracentesis: Chronic Liver Disease Questionnaire (CLDQ). The CLDQ includes 29 symptom questions, scored on a likert scale of 1-7 (where 1 is all of the time and 7 is none of time), and divided into 6 domains: fatigue, activity, emotional function, abdominal symptoms, systemic symptoms, and worry). Edmonton Symptom Assessment System-revised version (ESAS-R). The ESAS-R includes 10 symptoms (9 pre-determined and 1 'other' free text scale), scored on a likert scale 0-10 (where 0 is 'No' and 10 is 'Worst possible'). Ascites Symptom Inventory-7 (ASI-7). The ASI-7 includes 7 symptom questions, scored on a likert scale of 0-4 where 0 is 'does not apply at all' and 4 is 'very strongly applies'.

History and physical examination: Demographics, Past Medical History, Medications, History of prior ascites fluid infections, other infections, and antibiotic use in the last 6 months, Liver disease severity-model for end stage liver disease (MELD, score range 6-40, where a higher score indicates higher mortality risk ) score & Child Pugh score (score range 5-15, where a higher score indicates worse liver function), Resting blood pressure.

Day 1-90 (Day 1=drain placement day)

Adverse event monitoring and patient follow-up:

Pre-drain insertion abdominal wall ultrasound by the interventional radiologist who will be inserting the drain Drain placement associated safety outcomes will be recorded including: shunt misplacement, insertion bleeding, pain (10 point scale where 0 is 'no pain' and 10 is 'worst possible pain') Home care nurse visit assessment with each drain: vital signs, documentation of drain function, appearance, fluid drainage, fluid volume, fluid appearance, drain site description, patient symptoms.

Nurses will be asked to contact study personnel in the event of adverse outcomes or new patient symptoms Phone call to patient weekly and in person assessment monthly by primary investigator (PI): quality of life and symptom questionnaires-CLDQ, ESAS-R, ASI-7, changes in cognitive status, medication reassessment, documentation of hospitalizations, and Child Pugh/MELD calculation at monthly visit.

Monthly Nutritional assessment by dietitian-Weight, height, calorie and protein intake via 3-day food record (completed 1 day pre-drain, 1 day of a drain, and 1 day after a drain), mid-arm muscle circumference, hand-grip strength by the Jamar hand-grip dynamometer, CNAQ appetite screening tool

Diagnostic fluid analysis and septic work up if symptoms of SBP (abdominal pain, fever, elevated white blood cell count (WBC), sudden onset renal dysfunction or hepatic encephalopathy). Drain removal if SBP diagnosed using standard criteria (ascites fluid polymorphonuclear cell count ≥ 250 cells/millimetre3). Any removed drains with have the drain tip sent for culture and sensitivity

Labs: Weekly ascites fluid analysis for protein, cell count and diff, culture and sensitivity Weekly CBC and differential, PT, Cr, electrolytes, ALT, AST, Bilirubin, albumin via home collections or community based lab. Urine electrolytes, Plasma renin & aldosterone monthly

STUDY EXTENSION OPTION

At 90 days, all patients that choose to continue with fluid drainage as per the study protocol, will be offered the option to continue contributing data to the study for the duration of time they have the drain inserted, or until they no longer wish to participate. Patients will be made aware that their decision to continue to participate in the study will not influence their medical care.

For patients that agree to continue participating, the initial protocol for drain frequency, volume, care, and safety measures will be followed. Data will be collected, including:

Every 4 weeks by PI or designate: quality of life and symptom questionnaires-CLDQ, ESAS-R, ASI-7, changes in cognitive status, medication reassessment, documentation of hospitalizations, and Child Pugh/MELD calculation, vital signs, documentation of drain function, appearance, drain site description, patient symptoms. Patients will be asked to bring in their home drain volume records for review at these visits. Nutritional assessment by dietitian-Weight, height, calorie and protein intake via 3-day food record (completed 1 day pre-drain, 1 day of a drain, and 1 day after a drain), mid-arm muscle circumference, hand-grip strength by the Jamar hand-grip dynamometer, CNAQ appetite screening tool.

Diagnostic fluid analysis and septic work up if symptoms of SBP (abdominal pain, fever, elevated WBC, sudden onset renal dysfunction or hepatic encephalopathy) Drain removal if SBP diagnosed using standard criteria (ascites fluid polymorphonuclear cell count ≥ 250 cells/mm3). Any removed drains with have the drain tip sent for culture and sensitivity.

Labs: Every 1-2 weeks-ascites fluid analysis for protein, cell count and diff, culture and sensitivity. Blood for CBC and differential, PT, Cr, electrolytes, AST, Bilirubin, albumin Every 4 weeks- blood rennin and aldosterone. Urine electrolytes.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Prospective Evaluation of PleurX Drain for Treatment of Cirrhotic Refractory Ascites
• Actual Study Start Date: May 18, 2016
• Actual Primary Completion Date: March 20, 2019
• Actual Study Completion Date: March 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: PleurX catheter intervention; Participants will undergo placement and follow up monitoring of PleurX catheter.	Device: PleurX catheter; Placement of PleurX catheter for refractory cirrhotic ascites, with follow up monitoring

Outcome Measures

Primary Outcome Measures :

1. Ascites Symptom Inventory (ASI-7) [ Time Frame: Change from baseline to 6 months ]
   Includes 7 symptom questions, scored on a Likert scale of 0-4 where 0 is 'does not apply at all' and 4 is 'very strongly applies'

Secondary Outcome Measures :

1. Model for End Stage Liver Disease - Sodium (MELD-Na) score [ Time Frame: Change from baseline to 6 months ]
   Score range 6-40, where a higher score indicates higher mortality risk
2. Level of serum creatinine [ Time Frame: Change from baseline to 6 months ]
   Physiological parameter measure un umol/L
3. Council on Nutrition Appetite Questionnaire (CNAQ) [ Time Frame: Change from baseline to 6 months ]
   Includes 8 questions where total score range is 8-40. A lower score indicates more problems with appetite
4. Level of serum albumin [ Time Frame: Change from baseline to 6 months ]
   Physiological parameter expressed in g/dL
5. Cost of care [ Time Frame: Change from baseline to 6 months ]
   Expressed in Canadian dollars (CAD)
6. Chronic Liver Disease Questionnaire (CLDQ) [ Time Frame: Change from baseline to 6 months ]
   Includes 29 symptom questions, scored on a Likert scale of 1-7 (where 1 is all of the time and 7 is none of time), and divided into 6 domains: fatigue, activity, emotional function, abdominal symptoms, systemic symptoms, and worry)
7. Edmonton Symptom Assessment System-revised version (ESAS-R) [ Time Frame: Change from baseline to 6 months ]
   Includes 10 symptoms (9 pre-determined and 1 'other' free text scale), scored on a Likert scale 0-10 (where 0 is 'No' and 10 is 'Worst possible')
8. Total calorie and protein intake [ Time Frame: Change from baseline to 6 months ]
   Total food and drink intake is recorded for 3 days. Total calorie and protein (grams) intake are then calculated based on reported intake.
9. Visual Analog Pain scale [ Time Frame: Change from baseline to 6 months ]
   Likert scale 0-10, where 0 is no pain and 10 is worst possible pain.
10. Child Pugh score [ Time Frame: Change from baseline to 6 months ]
    Score range 5-15, where a higher score indicates worse liver function

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Cirrhosis (based on imaging, liver function test abnormalities, biopsy, or portal hypertension associated complications)
• Refractory or resistant ascites
• Not a candidate for TIPS (hospital admissions for encephalopathy, Model for End Stage Liver Disease (MELD) ≥18, diastolic dysfunction (defined as E/A ratio <1 on echocardiogram), patient declined, advanced age, renal disease)
• Requiring large volume paracentesis ≥twice/month

Exclusion Criteria:

• Malignant ascites due to peritoneal carcinomatosis (requires positive fluid cytology)
• Patient unwilling to let home care staff enter home
• Patient unwilling to have intravenous albumin
• Patient unwilling to have drain placed
• Patients post liver transplant
• multi-loculated ascites

Contacts and Locations

Sponsors and Collaborators

University of Alberta

Becton, Dickinson and Company

Investigators

• Principal Investigator: Puneeta Tandon; University of Alberta
• Principal Investigator: Juan G Abraldes; University of Alberta

More Information

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• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT04569565
• Other Study ID Numbers: Pro00055611
• First Posted: September 30, 2020
• Last Update Posted: September 30, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to share individual participant data with other researchers

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ascites; Pathologic Processes