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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Icodextrin

peritoneal dialysate

Group Type EXPERIMENTAL

Icodextrin

Intervention Type DRUG

one exchange daily

Glucose-based dialysate

peritoneal dialysate

Group Type ACTIVE_COMPARATOR

glucose-based peritoneal dialysate

Intervention Type DRUG

original exchange frequency

Interventions

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Icodextrin

one exchange daily

Intervention Type DRUG

glucose-based peritoneal dialysate

original exchange frequency

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No