Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis

Phase 4

Completed

• Conditions: Peritonitis
• Interventions: Drug: Icodextrin; Drug: glucose-based peritoneal dialysate

• Registration Number: NCT01044446
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Primary Completion: 2012-08
• Study Completion: 2013-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Icodextrin	Icodextrin	peritoneal dialysate
Glucose-based dialysate	glucose-based peritoneal dialysate	peritoneal dialysate

Primary Outcome Measures

Name	Time	Method
peritoneal dialysate total white cell count on day 3 of acute peritonitis	day 3

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong; 🇭🇰 Shatin, New Territories, Hong Kong