A double-blind, placebo controlled randomised study to assess the tolerability, safety, and preliminary efficacy of taurolidine-citrate lock solution (TauroLock™) in patients with recurrent pleural effusions requiring management with Indwelling Pleural Catheters for recurrent effusion drainage.
St John of God Midland Hospital
18 participants
Oct 1, 2022
Interventional
Conditions
Summary
Taurolidine-citrate solution has been used effectively as a catheter-lock device to reduce infection and blockage in central venous catheters and tunnelled peritoneal catheters and has been used intra-pleurally. This study aims to assess the safety of Taurolidine-citrate (TauroLock) in indwelling pleural catheters (IPCs).
Eligibility
Inclusion Criteria2
- Patients with an Indwelling Pleural Catheter (IPC) for recurrent pleural effusion who consent to the trial.
- Must be within community nursing service catchment (e.g. Silver Chain) and be able to attend follow up appointments at SJOG Midland as required.
Exclusion Criteria9
- Patients unable to provide informed consent
- Life expectancy <3 months
- Known adverse reaction to taurolidine or citrate
- Patient requiring other intrapleural medication
- Active bleeding of sufficient severity to warrant hospital admission or withholding of regular anticoagulation therapy
- Severe renal impairment (eGFR <30)
- Concurrent pregnancy, lactation
- Patients with previous documented pleural infection within 6 months
- Uncontrolled pain at baseline
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Interventions
A syringe containing 5ml of TauroLock™ solution (Taurolidine 1%-citrate 4%) or placebo (0.9% sodium chloride) will be used as test drug/placebo in this study. Patients will be randomised to receive either test drug or placebo first. 2.5ml of solution will be instilled into the indwelling pleural catheter within 7 days of insertion (immediately following pleural drainage) and repeated 4 weeks later (with the taurolidine-citrate/placebo, whichever they did not receive). TauroLock/placebo will be instilled twice to each patient ie. each patient will receive both TauroLock and placebo 4 weeks apart. This will be performed by clinical research fellow and documented in medication chart at the time of intervention.
Locations(1)
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ACTRN12622001280796