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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Completed
Phase 4

Conditions

Peritonitis

Treatments

Drug: glucose-based peritoneal dialysate
Drug: Icodextrin

Study type

Interventional

Funder types

Other

Identifiers

NCT01044446
CRE-2009.481

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

Icodextrin
Experimental group
Description:
peritoneal dialysate
Treatment:
Drug: Icodextrin
Glucose-based dialysate
Active Comparator group
Description:
peritoneal dialysate
Treatment:
Drug: glucose-based peritoneal dialysate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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