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

This study is currently recruiting participants.

Verified January 2010 by Chinese University of Hong Kong

First Received on January 6, 2010. Last Updated on June 22, 2011 History of Changes

Sponsor:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT01044446

Purpose

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.

Condition	Intervention	Phase
Peritonitis	Drug: Icodextrin Drug: glucose-based peritoneal dialysate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

Drug Information available for: Dextrose Icodextrin

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

peritoneal dialysate total white cell count on day 3 of acute peritonitis [ Time Frame: day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	January 2010
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Icodextrin peritoneal dialysate	Drug: Icodextrin one exchange daily
Active Comparator: Glucose-based dialysate peritoneal dialysate	Drug: glucose-based peritoneal dialysate original exchange frequency

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044446

Locations

Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong	Recruiting
Shatin, New Territories, Hong Kong, SAR
Contact: Kai Ming Chow, MBChB 852-26323131 Chow_Kai_Ming@alumni.cuhk.net
Principal Investigator: Kai Ming Chow, MBChB, MRCP

Sponsors and Collaborators

Chinese University of Hong Kong

More Information

No publications provided

Responsible Party:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT01044446 History of Changes
Other Study ID Numbers:	CRE-2009.481
Study First Received:	January 6, 2010
Last Updated:	June 22, 2011
Health Authority:	Hong Kong: Chinese University of Hong Kong

Keywords provided by Chinese University of Hong Kong:

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

Additional relevant MeSH terms:

Peritonitis
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012