Back to resultsEffect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis
Primary Purpose
Peritonitis
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Icodextrin
glucose-based peritoneal dialysate
Sponsored by
About this trial
This is an interventional treatment trial for Peritonitis focused on measuring peritoneal dialysis, peritonitis, CAPD, end-stage renal disease, peritonitis outcome and ultrafiltration
Eligibility Criteria
Inclusion Criteria:
- aged 18 or older on peritoneal dialysis, who develop clinical evidence of peritonitis
- stable peritoneal dialysis with Baxter connection system
- willingness to give written consent and comply with the study protocol
Exclusion Criteria:
- already on icodextrin dialysate prior to acute presentation with peritonitis
- known allergy or hypersensitivity to icodextrin, starch or have a glycogen storage disease
- participation in another interventional study within last 30 days of randomization
- history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
Sites / Locations
- Prince of Wales Hospital, Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Icodextrin
Glucose-based dialysate
Arm Description
peritoneal dialysate
peritoneal dialysate
Outcomes
Primary Outcome Measures
peritoneal dialysate total white cell count on day 3 of acute peritonitis
Secondary Outcome Measures
need of additional hypertonic exchanges, ultrafiltration volumes according to patient diary, fluid control as denoted by changes in body weight, and the timing of peritonitis resolution
Full Information
NCT ID
NCT01044446
First Posted
January 6, 2010
Last Updated
August 9, 2016
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01044446
Brief Title
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis
Official Title
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing glucose exposure, extent and severity of peritonitis will be evaluated in the setting of acute peritonitis complicating peritoneal dialysis among patients who are not receiving icodextrin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis
Keywords
peritoneal dialysis, peritonitis, CAPD, end-stage renal disease, peritonitis outcome and ultrafiltration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Icodextrin
Arm Type
Experimental
Arm Description
peritoneal dialysate
Arm Title
Glucose-based dialysate
Arm Type
Active Comparator
Arm Description
peritoneal dialysate
Intervention Type
Drug
Intervention Name(s)
Icodextrin
Intervention Description
one exchange daily
Intervention Type
Drug
Intervention Name(s)
glucose-based peritoneal dialysate
Intervention Description
original exchange frequency
Primary Outcome Measure Information:
Title
peritoneal dialysate total white cell count on day 3 of acute peritonitis
Time Frame
day 3
Secondary Outcome Measure Information:
Title
need of additional hypertonic exchanges, ultrafiltration volumes according to patient diary, fluid control as denoted by changes in body weight, and the timing of peritonitis resolution
Time Frame
within the period of peritonitis treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18 or older on peritoneal dialysis, who develop clinical evidence of peritonitis
stable peritoneal dialysis with Baxter connection system
willingness to give written consent and comply with the study protocol
Exclusion Criteria:
already on icodextrin dialysate prior to acute presentation with peritonitis
known allergy or hypersensitivity to icodextrin, starch or have a glycogen storage disease
participation in another interventional study within last 30 days of randomization
history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
Facility Information:
Facility Name
Prince of Wales Hospital, Chinese University of Hong Kong
City
Shatin
State/Province
New Territories
ZIP/Postal Code
SAR
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
24578470
Citation
Chow KM, Szeto CC, Kwan BC, Pang WF, Ma T, Leung CB, Law MC, Li PK. Randomized controlled study of icodextrin on the treatment of peritoneal dialysis patients during acute peritonitis. Nephrol Dial Transplant. 2014 Jul;29(7):1438-43. doi: 10.1093/ndt/gfu033. Epub 2014 Feb 26.
Results Reference
derived
Learn more about this trial
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis
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