The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
- Conditions
- Peritoneal Dialysis, Continuous AmbulatoryPeritoneal Dialysis
- Interventions
- Drug: Tissue Plasminogen Activator (tPA)
- Registration Number
- NCT01478698
- Lead Sponsor
- Sir Charles Gairdner Hospital
- 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 intraperitoneal white cell count).
Aims:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single dose Tissue Plasminogen Activator (tPA) 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. 4 doses recombinant deoxyribonuclease (DNase) The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days. Single dose recombinant deoxyribonuclease (DNase) 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. 2 doses Tissue Plasminogen Activator (tPA) The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day 2 doses recombinant deoxyribonuclease (DNase) The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day 4 doses Tissue Plasminogen Activator (tPA) The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days.
- Primary Outcome Measures
Name Time Method Adverse reactions 72 hours Participants will be examined for potential adverse reactions during this trial, including - pain; abnormalities in systemic coagulation profile; bleeding; and altered blood pressure.
- Secondary Outcome Measures
Name Time Method Biochemical markers of inflammation 21 days Biochemical markers of inflammation will be measured on days 1, 3, 5, 7, 14 and 21, including - c-reactive protein, white cell count, dialysate white cell count, procalcitonin
Clinical markers of inflammation 21 days pain score; days till pain free; proportion requiring catheter removal; days of hospitalisation; days of fever (temperature \> 37.0 degrees on at least one occasion)
Trial Locations
- Locations (1)
Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia
Sir Charles Gairdner Hospital🇦🇺Perth, Western Australia, Australia