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| Name | Class |
|---|---|
| The University of Western Australia | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose | Experimental | 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. |
|
| 2 doses | Experimental | The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day |
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| 4 doses | Experimental | The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days. |
|
| control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue Plasminogen Activator (tPA) | Drug | tPA 10mg per dose intraperitoneal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical markers of inflammation |
| Measure | Description | Time Frame |
|---|---|---|
| Additional variables | gentamycin and vancomycin levels, ultrafiltration volume; mortality; relapse and recurrence rates of peritonitis | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aron Chakera, DPhil | Sir Charles Gairdner Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Charles Gairdner Hospital | Perth | Western Australia | 6009 | Australia |
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| recombinant deoxyribonuclease (DNase) | Drug | DNase 5mg per dose given intraperitoneally. |
|
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 |
| ID | Term |
|---|---|
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| C568813 | dornase alfa |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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