The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
NCT ID: NCT01478698
Last Updated: 2022-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2016-01-01
2022-05-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single dose
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.
Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal
recombinant deoxyribonuclease (DNase)
DNase 5mg per dose given intraperitoneally.
2 doses
The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day
Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal
recombinant deoxyribonuclease (DNase)
DNase 5mg per dose given intraperitoneally.
4 doses
The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days.
Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal
recombinant deoxyribonuclease (DNase)
DNase 5mg per dose given intraperitoneally.
control
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.
No interventions assigned to this group
Interventions
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Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal
recombinant deoxyribonuclease (DNase)
DNase 5mg per dose given intraperitoneally.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
100 Years
ALL
No
Sponsors
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The University of Western Australia
OTHER
Sir Charles Gairdner Hospital
OTHER
Responsible Party
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Aron Chakera
Dr
Principal Investigators
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Aron Chakera, DPhil
Role: STUDY_DIRECTOR
Sir Charles Gairdner Hospital
Locations
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Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Countries
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Other Identifiers
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tPADNase 1
Identifier Type: -
Identifier Source: org_study_id
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