Back to resultsIV Antibiotics With Lavage for Severe PD Peritonitis
Primary Purpose
Peritonitis, Kidney Failure
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Intravenous vancomycin & gentamicin with adjunctive lavage
Intraperitoneal vancomycin & gentamicin
Sponsored by
About this trial
This is an interventional treatment trial for Peritonitis focused on measuring Peritoneal dialysis, Lavage
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
Sites / Locations
- Alice Ho Miu Ling Nethersole Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lavage arm
Standard treatment arm
Arm Description
Intravenous vancomycin & gentamicin with adjunctive lavage
Intraperitoneal vancomycin & gentamicin
Outcomes
Primary Outcome Measures
Peritoneal dialysate effluent (PDE) white cell count and bacterial culture
Number of participants requiring Tenckhoff catheter removal
Secondary Outcome Measures
Number of participants developing relapsing peritonitis
Number of participants requiring hospitalization
Full Information
NCT ID
NCT02926846
First Posted
October 1, 2016
Last Updated
January 29, 2018
Sponsor
Alice Ho Miu Ling Nethersole Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02926846
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alice Ho Miu Ling Nethersole Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis, Kidney Failure
Keywords
Peritoneal dialysis, Lavage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavage arm
Arm Type
Experimental
Arm Description
Intravenous vancomycin & gentamicin with adjunctive lavage
Arm Title
Standard treatment arm
Arm Type
Active Comparator
Arm Description
Intraperitoneal vancomycin & gentamicin
Intervention Type
Drug
Intervention Name(s)
Intravenous vancomycin & gentamicin with adjunctive lavage
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Intraperitoneal vancomycin & gentamicin
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Number of participants developing relapsing peritonitis
Time Frame
All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
Title
Number of participants requiring hospitalization
Time Frame
All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siu-Man Wong, MBChB, FRCPC
Organizational Affiliation
Alice Ho Miu Ling Nethersole Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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IV Antibiotics With Lavage for Severe PD Peritonitis
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