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Trial registered on ANZCTR


Registration number
ACTRN12623001030662
Ethics application status
Approved
Date submitted
25/08/2023
Date registered
22/09/2023
Date last updated
22/09/2023
Date data sharing statement initially provided
22/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Abdominal drains for ascites
Scientific title
Long-term abdominal drains in refractory ascites due to end stage liver disease, a pilot study
Secondary ID [1] 310473 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ascites 331264 0
End stage liver disease 331350 0
Condition category
Condition code
Oral and Gastrointestinal 328019 328019 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Determine the suitability of long term abdominal drains (LTAD) in managing ascites.
Upon consent, participants will have a LTAD inserted into their abdomen in hospital by a trained interventional radiologist. Participants will be admitted overnight under the Hepatology unit. Rocket® LTAD catheters (Rocket Medical, Watford, UK) will be inserted in the angiography suite by interventional radiologists using a combination of Seldinger and tunnelling procedure as stated in the Rocket information sheet (Rocket Medical. Indwelling Peritoneal Catheter (IPC) Insertion Kit R54400–16-40. As part of standard of care within the Hepatology Unit, all participants undergoing an invasive procedure will be assessed for their risk of bleeding during admission. Based on prior standard of care bloods, INR and platelet counts will be assessed by the clinical team to determine if additional tests are required (INR=1.5 OR Platelet count =50,000). If required, on the day of admission for LTAD insertion, participants will have a blood sample collected for rotational thromboelastometry (ROTEM) testing as per standard of care. ROTEM testing can predict the risk of thrombosis and bleeding in liver disease patients. This standard of care process will be explained to the participant at admission by the liver team. If an abnormal ROTEM result is present, the participant will receive blood products guided by the ROTEM algorithm practised in the unit prior to their invasive procedure. As per the ROTEM algorithm participants will receive FFP, cryoprecipitate and/or platelets as required. Participants will be observed overnight and a complete ascitic drain will be done via LTAD prior to discharge.

At discharge, participants will be provided with an information kit (specifically designed for the study) and details of when the at-home drains will begin. A referral will also be made prior to discharge to the Metropolitan Referral Unit indicating frequency of drains (how many times a week) and a community nurse will coordinate the times to attend with patient. . All participants will be prescribed antibiotics (if not already on them, norfloxacin 400 mg once a day or equivalent) for the duration of the study to avoid the risk of infection. Participant will be provided with the drain supplies on discharge for community nurses to use.

Drains will be dependent on the participant's clinical need, with drains up to 3-4 times a week with a maximum of 2L of ascitic fluid drained at home (1hr appointments) by the community care nurses. On arrival, the community nurse will complete an assessment of the patient as per their normal routine i.e. observations. Next, the community nurse, using a Rocket 2000ml drainage bag pack, will remove patients dressing, attach the drainage bag and conduct the drain with up to 2000ml of ascitic fluid to be drained over a time of 10-30minutes. The drainage bag is then disconnected and a new dressing reapplied – all completed as per protocol. The study specific diary will also be completed, documenting patients weight, amount drained and time drainage took.

Participants will be followed up weekly by the chronic liver disease nurses (10mins phone call), and have a monthly follow-up in clinic (20 minutes) with their treating doctor and the chronic liver disease nurse. The intervention (at-home drains) will be for 6mths.





Intervention code [1] 326864 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335889 0
Feasibility and logistics of LTADs within SA health (composite outcome). Feasibility as determined by the uptake of long term abdominal drains by eligible patients assessed by the audit of study records and pre-screening log, and logistics as determined by the ability to insert drains within the hospital setting.
Timepoint [1] 335889 0
End of study (24mths)
Primary outcome [2] 335890 0
Number and rate of patient recruitment over 24 months (composite outcome), as determined from the study pre-screening log.
Timepoint [2] 335890 0
End of study (24mths)
Secondary outcome [1] 425999 0
Safety by measurement of adverse outcomes due to LTAD including the frequency and incidence of infections (peritonitis and infections at site of LTAD), leakage from LTAD, bleeding, and renal failure. Safety will be assessed by clinical examination (at each home visit and clinic appointment) and by self-reported outcomes by the participant by study-specific questionnaire.
Timepoint [1] 425999 0
Safety measures will be collected each week from the participant over the course of the 6-month intervention period, and collated and analysed for the outcome measure at the end of the study.
Secondary outcome [2] 426000 0
Efficacy as assessed by the number of hospital visits for paracentesis avoided as assessed by hospitalisation data collected from medical records.
Timepoint [2] 426000 0
Medical record data collected for 6mths post-enrolment.
Secondary outcome [3] 426001 0
Acceptability using satisfaction surveys designed specifically for this study (patients and carers)
Timepoint [3] 426001 0
3 and 6 mths post-enrolment
Secondary outcome [4] 426312 0
Breakthrough hospitalisation for ascites as assessed by hospitalisation data collected from medical records.
Timepoint [4] 426312 0
Medical record data collected 6mths post-enrolment

Eligibility
Key inclusion criteria
Age >18 years with capacity to consent for treatment
Patient with mild cognitive impairment, at treating doctor and/or PI’s discretion
Refractory ascites
Ascites that is unresponsive to fluid and sodium restriction, and high-dose diuretic treatment (spironolactone 400 mg/day and/or furosemide 160 mg/day) with or without intolerance to diuretics
Ascites that recurs rapidly after LVP (requiring one or more LVP/month).
Considered ineligible to undergo LT and or trans jugular intrahepatic portosystemic shunts (TIPSS)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with loculated ascites
Patients with large exophytic liver tumours
Patients with chronic abdominal pain
Patients with extensive abdominal wall scars
Patients unlikely to tolerate with abdominal drains at home as judged by the treating medical team
Patients with active spontaneous bacterial peritonitis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/09/2022
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
20
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25452 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 41235 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 314677 0
Government body
Name [1] 314677 0
SALHN Research Enquiry Grant Round
Country [1] 314677 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Flinders Medical CentreFlinders Drive, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 316646 0
None
Name [1] 316646 0
Address [1] 316646 0
Country [1] 316646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313695 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 313695 0
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 313695 0
Australia
Date submitted for ethics approval [1] 313695 0
16/03/2022
Approval date [1] 313695 0
17/06/2022
Ethics approval number [1] 313695 0
2022/HRE00044

Summary
Brief summary
Chronic liver diseases, from any aetiology, progress over time to cirrhosis if untreated. Ascites-related readmissions are the predominant cause of hospitalisations in these patients, especially in the last few months of life. Large volume paracentesis is the only therapeutic option in those who cannot undergo LT. LVPs are typically performed every week or two in medical day-care units (MDU) as elective procedures, or as emergency hospital admissions. There are practical difficulties in organising LVPs due to bed limitations in the medical day-care unit, and this situation often leads to emergency room presentations and hospitalisations. Since ascites drainage in patients unsuitable for LT is a palliative procedure, it is best done in the comfort of their homes on a regular basis. This study explores the possibility of an alternative procedure via a catheter inserted in the abdomen and repeated small-quantity drainages (simply, long-term abdominal drains or LTADs).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129046 0
Dr Jeyamani Ramachandran
Address 129046 0
Lvl 3, Department of Gastroenterology and Hepatology
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 129046 0
Australia
Phone 129046 0
+61 8 82046869
Fax 129046 0
Email 129046 0
jeyamani.ramachandran@sa.gov.au
Contact person for public queries
Name 129047 0
Ms Kylie Bragg
Address 129047 0
Lvl 3, Department of Gastroenterology and Hepatology
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 129047 0
Australia
Phone 129047 0
+61 8 8204 6989
Fax 129047 0
Email 129047 0
kylie.bragg@sa.gov.au
Contact person for scientific queries
Name 129048 0
Dr Jeyamani Ramachandran
Address 129048 0
Lvl 3, Department of Gastroenterology and Hepatology
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 129048 0
Australia
Phone 129048 0
+61 8 82046869
Fax 129048 0
Email 129048 0
jeyamani.ramachandran@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data for this trial will analysed as a group to determine whether the long-term abdominal drains benefits the patient population. As per ethics approval, IPD will not be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20139Study protocol    386497-(Uploaded-25-08-2023-15-50-03)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.