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

Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01044446

Enrollment

Registered

2010-01-07

Start date

2010-01-31

Completion date

2013-04-30

Last updated

2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritonitis

Keywords

peritoneal dialysis, peritonitis, CAPD, end-stage renal disease, peritonitis outcome and ultrafiltration

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.

Interventions

DRUGIcodextrin

one exchange daily

DRUGglucose-based peritoneal dialysate

original exchange frequency

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
peritoneal dialysate total white cell count on day 3 of acute peritonitis	day 3

Secondary

Measure	Time frame
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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026