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

August 9, 2016 updated by: Chow Kai Ming, Chinese University of Hong Kong

Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong, SAR
        • Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Icodextrin
peritoneal dialysate
Drug: Icodextrin
one exchange daily
ACTIVE_COMPARATOR: Glucose-based dialysate
peritoneal dialysate
Drug: glucose-based peritoneal dialysate
original exchange frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
peritoneal dialysate total white cell count on day 3 of acute peritonitis
Time Frame: day 3
day 3

Secondary Outcome Measures

Outcome 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
Time Frame: within the period of peritonitis treatment
within the period of peritonitis treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (ESTIMATE)

January 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2009.481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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