- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478698
The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
May 12, 2022 updated by: Aron Chakera, Sir Charles Gairdner Hospital
A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis
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:
- To examine the tolerability of different doses of intraperitoneal tPA and DNase compared to standard treatment.
- To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the addition of intraperitoneal tPA and DNase to usual therapy.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Western Australia
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Perth, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
tPA 10mg per dose intraperitoneal
DNase 5mg per dose given intraperitoneally.
|
EXPERIMENTAL: 2 doses
The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day
|
tPA 10mg per dose intraperitoneal
DNase 5mg per dose given intraperitoneally.
|
EXPERIMENTAL: 4 doses
The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days.
|
tPA 10mg per dose intraperitoneal
DNase 5mg per dose given intraperitoneally.
|
NO_INTERVENTION: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse reactions
Time Frame: 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.
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical markers of inflammation
Time Frame: 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
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21 days
|
Clinical markers of inflammation
Time Frame: 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)
|
21 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional variables
Time Frame: 3 months
|
gentamycin and vancomycin levels, ultrafiltration volume; mortality; relapse and recurrence rates of peritonitis
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Aron Chakera, DPhil, Sir Charles Gairdner Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ACTUAL)
May 13, 2022
Study Completion (ACTUAL)
May 13, 2022
Study Registration Dates
First Submitted
November 21, 2011
First Submitted That Met QC Criteria
November 22, 2011
First Posted (ESTIMATE)
November 23, 2011
Study Record Updates
Last Update Posted (ACTUAL)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 12, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tPADNase 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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