IV Antibiotics With Lavage for Severe PD Peritonitis

January 29, 2018 updated by: Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peritoneal dialysate effluent (PDE) white cell count and bacterial culture
Time Frame: PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks
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
Time Frame: Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment
Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants developing relapsing peritonitis
Time Frame: All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
Number of participants requiring hospitalization
Time Frame: All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment
All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alice Ho Miu Ling Nethersole Hospital

Investigators

  • Principal Investigator: Siu-Man Wong, MBChB, FRCPC, Alice Ho Miu Ling Nethersole Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

October 1, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013.201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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