Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedAugust 10, 2016
August 1, 2016
2.6 years
January 6, 2010
August 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
peritoneal dialysate total white cell count on day 3 of acute peritonitis
day 3
Secondary Outcomes (1)
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
within the period of peritonitis treatment
Study Arms (2)
Icodextrin
EXPERIMENTALperitoneal dialysate
Glucose-based dialysate
ACTIVE COMPARATORperitoneal dialysate
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, SAR, Hong Kong
Related Publications (1)
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.
PMID: 24578470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Consultant
Study Record Dates
First Submitted
January 6, 2010
First Posted
January 7, 2010
Study Start
January 1, 2010
Primary Completion
August 1, 2012
Study Completion
April 1, 2013
Last Updated
August 10, 2016
Record last verified: 2016-08