IV Antibiotics With Lavage for Severe PD Peritonitis

Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926846
• Other study ID #: 2013.201
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2016
• Last updated: January 29, 2018
• Start date: March 2014
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Alice Ho Miu Ling Nethersole Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure
• Peritonitis
• Renal Insufficiency

Intervention

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)
• 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)

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Alice Ho Miu Ling Nethersole Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants requiring Tenckhoff catheter removal		Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment
Secondary	Number of participants developing relapsing peritonitis		All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
Secondary	Number of participants requiring hospitalization		All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment