IV Antibiotics With Lavage for Severe PD Peritonitis

Sponsor

Alice Ho Miu Ling Nethersole Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02926846

Collaborator

(none)

Enrollment

Location

Arms

46.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peritonitis Kidney Failure	Drug: Intravenous vancomycin & gentamicin with adjunctive lavage Drug: Intraperitoneal vancomycin & gentamicin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lavage arm Intravenous vancomycin & gentamicin with adjunctive lavage	Drug: 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)
Active Comparator: Standard treatment arm Intraperitoneal vancomycin & gentamicin	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)

Arm

Intervention/Treatment

Experimental: Lavage arm

Intravenous vancomycin & gentamicin with adjunctive lavage

Drug: 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)

Active Comparator: Standard treatment arm

Intraperitoneal vancomycin & gentamicin

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)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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