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

Peritonitis Clinical Trial

Official title:

Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044446
• Other study ID #: CRE-2009.481
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2010
• Last updated: August 9, 2016
• Start date: January 2010
• Est. completion date: April 2013

Study information

• Verified date: August 2016
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Chinese University of Hong Kong
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peritonitis

Intervention

Drug:
• Icodextrin
one exchange daily
• glucose-based peritoneal dialysate
original exchange frequency

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, Chinese University of Hong Kong	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peritoneal dialysate total white cell count on day 3 of acute peritonitis		day 3	No
Secondary	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		within the period of peritonitis treatment	No