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

Phase 1TerminatedNCT01478698

Sir Charles Gairdner Hospital5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peritoneal Dialysis Peritoneal Dialysis, Continuous Ambulatory

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 72 hours

Secondary Outcomes

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

Time frame: 21 days

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)