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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chow Kai Ming, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01044446
First received: January 6, 2010
Last updated: July 3, 2013
Last verified: July 2013
  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 4

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:


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 ]

Enrollment: 56
Study Start Date: January 2010
Study Completion Date: April 2013
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong, SAR
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Chow Kai Ming, Associate Consultant, 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: July 3, 2013
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
Digestive System Diseases
Infection
Intraabdominal Infections
Peritoneal Diseases
Dialysis Solutions
Icodextrin
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014