IV Antibiotics With Lavage for Severe PD Peritonitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial on Intravenous Antibiotics With Adjunctive Lavage for Severe Peritoneal-dialysis Related Peritonitis

Conditions
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Peritonitis, Kidney Failure

Intervention / Treatment
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* Drug: Intravenous vancomycin & gentamicin with adjunctive lavage
* Drug: Intraperitoneal vancomycin & gentamicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prevalent PD patients with age >= 18 years old suffering from PD peritonitis PD effluent white cell count >1090/mm2 on peritonitis day 3 Lack of clinical response Informed consent available Exclusion Criteria: PD peritonitis in association with exit site or tunnel infection Relapsing peritonitis (i.e. peritonitis caused by same organism within 4 weeks after completion of antibiotics therapy) Fungal peritonitis Mycobacterial peritonitis (both tuberculosis and non-tuberculosis species) Clinical suspicion of surgical peritonitis Penicillin- or cephalosporin allergy, that cefazolin and ceftazidime could not be used

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavage arm<br>Intravenous vancomycin & gentamicin with adjunctive lavage | Drug: Intravenous vancomycin & gentamicin with adjunctive lavage<br>* 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)<br>|
| Active Comparator: Standard treatment arm<br>Intraperitoneal vancomycin & gentamicin | Drug: Intraperitoneal vancomycin & gentamicin<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal dialysis, Lavage