Overview

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

Status:
Suspended

Trial end date:
2024-02-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sir Charles Gairdner Hospital

Collaborator:

The University of Western Australia

Treatments:

Plasminogen
Tissue Plasminogen Activator

Criteria

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