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The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients

Primary Purpose

Peritoneal Dialysis, Peritoneal Dialysis, Continuous Ambulatory

Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Tissue Plasminogen Activator (tPA)
recombinant deoxyribonuclease (DNase)
Sponsored by
Sir Charles Gairdner Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Dialysis focused on measuring peritoneal dialysis, peritoneal dialysis, continuous ambulatory, peritonitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. PD patient
  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:

  1. More than one organism on culture
  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

Sites / Locations

  • Sir Charles Gairdner Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Single dose

2 doses

4 doses

control

Arm Description

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.

The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day

The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days.

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.

Outcomes

Primary Outcome Measures

Adverse reactions
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
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
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)

Full Information

First Posted
November 21, 2011
Last Updated
May 12, 2022
Sponsor
Sir Charles Gairdner Hospital
Collaborators
The University of Western Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01478698
Brief Title
The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
Official Title
A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient budget for further study agents
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Charles Gairdner Hospital
Collaborators
The University of Western Australia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis, Peritoneal Dialysis, Continuous Ambulatory
Keywords
peritoneal dialysis, peritoneal dialysis, continuous ambulatory, peritonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single dose
Arm Type
Experimental
Arm Description
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.
Arm Title
2 doses
Arm Type
Experimental
Arm Description
The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day
Arm Title
4 doses
Arm Type
Experimental
Arm Description
The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days.
Arm Title
control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tissue Plasminogen Activator (tPA)
Intervention Description
tPA 10mg per dose intraperitoneal
Intervention Type
Drug
Intervention Name(s)
recombinant deoxyribonuclease (DNase)
Intervention Description
DNase 5mg per dose given intraperitoneally.
Primary Outcome Measure Information:
Title
Adverse reactions
Description
Participants will be examined for potential adverse reactions during this trial, including - pain; abnormalities in systemic coagulation profile; bleeding; and altered blood pressure.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Biochemical markers of inflammation
Description
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
Time Frame
21 days
Title
Clinical markers of inflammation
Description
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)
Time Frame
21 days
Other Pre-specified Outcome Measures:
Title
Additional variables
Description
gentamycin and vancomycin levels, ultrafiltration volume; mortality; relapse and recurrence rates of peritonitis
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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 Inability to provide written informed consent Systemic anticoagulation Severe uncontrolled hypertension Documented ulcerative gastrointestinal disease during the last three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aron Chakera, DPhil
Organizational Affiliation
Sir Charles Gairdner Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients

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