Kidney Failure, Peritonitis
Conditions
Keywords
Peritoneal dialysis, Lavage
Brief summary
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
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.
Interventions
DRUGIntravenous vancomycin & gentamicin with adjunctive lavage
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)
DRUGIntraperitoneal vancomycin & gentamicin
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)
Sponsors
Alice Ho Miu Ling Nethersole Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Hong Kong
Outcome results
None listed