IV Antibiotics With Lavage for Severe PD Peritonitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-01-31

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.

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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.

Conditions

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Peritonitis Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lavage arm

Intravenous vancomycin \& gentamicin with adjunctive lavage

Group Type EXPERIMENTAL

Intravenous vancomycin & gentamicin with adjunctive lavage

Intervention Type 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)

Standard treatment arm

Intraperitoneal vancomycin \& gentamicin

Group Type ACTIVE_COMPARATOR

Intraperitoneal vancomycin & gentamicin

Intervention Type 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)

Interventions

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Intravenous 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)

Intervention Type DRUG

Intraperitoneal 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)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No