Clinical trial NCT02926846: IV Antibiotics With Lavage for Severe PD Peritonitis
Official title: Randomized Trial on Intravenous Antibiotics With Adjunctive Lavage for Severe Peritoneal-dialysis Related Peritonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peritonitis
Kidney Failure
Keywords: Peritoneal dialysis
Lavage
Lead sponsor: Alice Ho Miu Ling Nethersole Hospital
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peritoneal dialysate effluent (PDE) white cell count and bacterial culture
timeFrame: PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks
measure: Number of participants requiring Tenckhoff catheter removal
timeFrame: Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment
Secondary outcomes:
measure: Number of participants developing relapsing peritonitis
timeFrame: All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
measure: Number of participants requiring hospitalization
timeFrame: All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
Study officials:
affiliation: Alice Ho Miu Ling Nethersole Hospital
name: Siu-Man Wong, MBChB, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: