The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
This trial is active, not recruiting.
|Conditions||peritoneal dialysis, peritoneal dialysis, continuous ambulatory|
|Treatments||tissue plasminogen activator (tpa), recombinant deoxyribonuclease (dnase)|
|Sponsor||Sir Charles Gairdner Hospital|
|Collaborator||The University of Western Australia|
|Start date||January 2016|
|End date||December 2020|
|Trial size||20 participants|
|Trial identifier||NCT01478698, tPADNase 1|
Intraperitoneal tPA and DNase is well tolerated at a number of different doses. Different doses of tPA and DNase will have a dose-related effect on inflammatory markers (CRP and intraperitoneal white cell count).
1. To examine the tolerability of different doses of intraperitoneal tPA and DNase compared to standard treatment.
2. To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the addition of intraperitoneal tPA and DNase to usual therapy.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
time frame: 72 hours
Biochemical markers of inflammation
time frame: 21 days
Clinical markers of inflammation
time frame: 21 days
Male or female participants from 18 years up to 100 years old.
Inclusion Criteria: 1. PD patient 2. 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 3. Age > 18 years old Exclusion Criteria: 1. More than one organism on culture 2. Contra-indication for systemic thrombolysis (eg. current or recent stroke, major haemorrhage or major trauma; proliferative retinopathy; major surgery in the previous 5 days) 3. Known sensitivity to DNase or t-PA 4. Pregnancy or lactating mother 5. Expected survival less than 3 months 6. Clinical indication for PD catheter removal, as defined by treating team 7. Inability to provide written informed consent 8. Systemic anticoagulation 9. Severe uncontrolled hypertension 10. Documented ulcerative gastrointestinal disease during the last three months
|Official title||A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis|
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