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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01044446
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : August 10, 2016
Information provided by (Responsible Party):
Chow Kai Ming, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Peritonitis Drug: Icodextrin Drug: glucose-based peritoneal dialysate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients
Study Start Date : January 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Icodextrin

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

Primary Outcome Measures :
  1. peritoneal dialysate total white cell count on day 3 of acute peritonitis [ Time Frame: day 3 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01044446

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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Chow Kai Ming, Associate Consultant, Chinese University of Hong Kong Identifier: NCT01044446    
Other Study ID Numbers: CRE-2009.481
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Keywords provided by Chow Kai Ming, Chinese University of Hong Kong:
peritoneal dialysis
end-stage renal disease
peritonitis outcome and ultrafiltration
Additional relevant MeSH terms:
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Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Dialysis Solutions
Pharmaceutical Solutions