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This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis related peritonitis.
The standard treatment of peritoneal dialysis (PD) related peritonitis is intraperitoneal (IP) antibiotics. In severe cases not responding to the IP antibiotics treatment, timely Tenckhoff catheter removal is needed. There is no known adjunctive measure that can improve the clinical outcome of the patients suffering from severe PD peritonitis.
Based on the past experience in the investigators' center, switching IP to intravenous route of antibiotics administration, together with adjunctive lavage was proposed to improve the clinical outcome of severe PD peritonitis, in particular a possible improved catheter salvage rate. This method will be evaluated in the present clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavage arm | Experimental | Intravenous vancomycin & gentamicin with adjunctive lavage |
|
| Standard treatment arm | Active Comparator | Intraperitoneal vancomycin & gentamicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous vancomycin & gentamicin with adjunctive lavage | Drug | Intravenous vancomycin and gentamicin are administered, together with adjunctive lavage performed by automated peritoneal dialysis machine over 48 to 72 hours. (choice of antibiotic is adjusted in accordance with the microbiology report when available) |
| Measure | Description | Time Frame |
|---|---|---|
| Peritoneal dialysate effluent (PDE) white cell count and bacterial culture | PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks | |
| Number of participants requiring Tenckhoff catheter removal | Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants developing relapsing peritonitis | All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment | |
| Number of participants requiring hospitalization | All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siu-Man Wong, MBChB, FRCPC | Alice Ho Miu Ling Nethersole Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alice Ho Miu Ling Nethersole Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D010538 | Peritonitis |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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|
| Intraperitoneal vancomycin & gentamicin | Drug | Intraperitoneal vancomycin and gentamicin are administered, with the usual continuous ambulatory peritoneal dialysis schedule maintained. (choice of antibiotic is adjusted in accordance with the microbiology report when available) |
|
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |