None listed
Conditions
Brief 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).
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 i
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.
Sponsors
St John of God Midland Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with an Indwelling Pleural Catheter (IPC) for recurrent pleural effusion who consent to the trial. 2. 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 criteria
1. Patients unable to provide informed consent 2. Life expectancy <3 months 3. Known adverse reaction to taurolidine or citrate 4. Patient requiring other intrapleural medication 5. Active bleeding of sufficient severity to warrant hospital admission or withholding of regular anticoagulation therapy 6. Severe renal impairment (eGFR <30) 7. Concurrent pregnancy, lactation 8. Patients with previous documented pleural infection within 6 months 9. Uncontrolled pain at baseline
Outcome results
None listed