The Effect of Intra-abdominal t-PA and and DNase on Peritonitis in Peritoneal Dialysis Patients
This study is not yet open for participant recruitment.
Verified November 2011 by Sir Charles Gairdner Hospital
Sponsor:
Sir Charles Gairdner Hospital
Collaborator:
The University of Western Australia
Information provided by (Responsible Party):
Neil Boudville, Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier:
NCT01478698
First received: November 21, 2011
Last updated: November 22, 2011
Last verified: November 2011
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Purpose
Intraperitoneal t-PA and DNase is well tolerated at a number of different doses.
Different doses of t-PA and DNase will have a dose-related effect on inflammatory markers (CRP and intraperitoneal white cell count).
| Condition | Intervention | Phase |
|---|---|---|
|
Peritoneal Dialysis Peritoneal Dialysis, Continuous Ambulatory |
Drug: Tissue Plasminogen Activator (tPA) Drug: recombinant deoxyribonuclease (DNase) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Intra-abdominal t-PA and and DNase on Peritonitis in Peritoneal Dialysis Patients: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Sir Charles Gairdner Hospital:
Primary Outcome Measures:
- Adverse reactions [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]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:
- biochemical markers of inflammation [ Time Frame: 21 days ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal
Drug: recombinant deoxyribonuclease (DNase)
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
|
Drug: Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal
Drug: recombinant deoxyribonuclease (DNase)
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.
|
Drug: Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal
Drug: recombinant deoxyribonuclease (DNase)
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478698
Locations
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | Not yet recruiting |
| Nedland, Western Australia, Australia, 6009 | |
| Contact: Neil Boudville, MBBS 08-93463333 neil.boudville@uwa.edu.au | |
| Principal Investigator: Neil Boudville, MBBS | |
Sponsors and Collaborators
Sir Charles Gairdner Hospital
The University of Western Australia
More Information
No publications provided
| Responsible Party: | Neil Boudville, Associate Professor, Sir Charles Gairdner Hospital |
| ClinicalTrials.gov Identifier: | NCT01478698 History of Changes |
| Other Study ID Numbers: | tPADNase 1 |
| Study First Received: | November 21, 2011 |
| Last Updated: | November 22, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Sir Charles Gairdner Hospital:
|
peritoneal dialysis peritoneal dialysis, continuous ambulatory peritonitis |
Additional relevant MeSH terms:
|
Peritonitis Peritoneal Diseases Digestive System Diseases Plasminogen Tissue Plasminogen Activator Fibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013