Status:
TERMINATED
The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
Lead Sponsor:
Sir Charles Gairdner Hospital
Collaborating Sponsors:
The University of Western Australia
Conditions:
Peritoneal Dialysis
Peritoneal Dialysis, Continuous Ambulatory
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
Hypothesis: 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 intraperi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01478698
Start Date
January 1 2016
End Date
May 13 2022
Last Update
May 19 2022
Active Locations (1)
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1
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009