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

Peritoneal Dialysis Clinical Trial

Official title:

A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01478698
• Other study ID #: tPADNase 1
• Status: Terminated
• Phase: Phase 1
• Start date: January 1, 2016
• Est. completion date: May 13, 2022

Study information

• Verified date: May 2022
• Source: Sir Charles Gairdner Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis
• Peritoneal Dialysis, Continuous Ambulatory
• Peritonitis

Intervention

Drug:
• Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal
• recombinant deoxyribonuclease (DNase)
DNase 5mg per dose given intraperitoneally.

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
Sir Charles Gairdner Hospital	The University of Western Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additional variables	gentamycin and vancomycin levels, ultrafiltration volume; mortality; relapse and recurrence rates of peritonitis	3 months
Primary	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.	72 hours
Secondary	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	21 days
Secondary	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)	21 days