The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
Peritoneal Dialysis, Peritoneal Dialysis, Continuous Ambulatory
About this trial
This is an interventional treatment trial for Peritoneal Dialysis focused on measuring peritoneal dialysis, peritoneal dialysis, continuous ambulatory, peritonitis
Eligibility Criteria
Inclusion Criteria:
- PD patient
- Proven peritonitis (as defined as at least 2 of: (i) Symptoms and/or signs of peritonitis; (ii) Cloudy dialysate OR dialysate white cell count > 100x 106/L with >50% neutrophils; (iii) Positive culture of dialysate
- Age > 18 years old
Exclusion Criteria:
- More than one organism on culture
- Contra-indication for systemic thrombolysis (eg. current or recent stroke, major haemorrhage or major trauma; proliferative retinopathy; major surgery in the previous 5 days)
- Known sensitivity to DNase or t-PA
- Pregnancy or lactating mother
- Expected survival less than 3 months
- Clinical indication for PD catheter removal, as defined by treating team
- Inability to provide written informed consent
- Systemic anticoagulation
- Severe uncontrolled hypertension
- Documented ulcerative gastrointestinal disease during the last three months
Sites / Locations
- Sir Charles Gairdner Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
No Intervention
Single dose
2 doses
4 doses
control
The first 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled into a dialysate bag and infused for a 4 hour intraperitoneal dwell.
The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day
The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days.
Any potential participants that have not consented into the intervention arms will be approached to be consented into a non-intervention observational control group. A maximum of 5 participants will be recruited into this control group.