IV Antibiotics With Lavage for Severe PD Peritonitis

Phase 4

Completed

• Conditions: Peritonitis; Kidney Failure
• Interventions: Drug: Intravenous vancomycin & gentamicin with adjunctive lavage; Drug: Intraperitoneal vancomycin & gentamicin

• Registration Number: NCT02926846
• Lead Sponsor: Alice Ho Miu Ling Nethersole Hospital

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-10-01
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Primary Completion: 2017-11
• Status Verified: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lavage arm	Intravenous vancomycin & gentamicin with adjunctive lavage	Intravenous vancomycin \& gentamicin with adjunctive lavage
Standard treatment arm	Intraperitoneal vancomycin & gentamicin	Intraperitoneal vancomycin \& gentamicin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Alice Ho Miu Ling Nethersole Hospital; 🇭🇰 Hong Kong, Hong Kong