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NCT Number: NCT01044446

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

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.

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Key information

Conditions

Peritonitis Chronic Disease Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Intraabdominal Infections Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, SAR, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Icodextrin

Drug

one exchange daily

glucose-based peritoneal dialysate

Drug

original exchange frequency

Primary outcomes

  1. peritoneal dialysate total white cell count on day 3 of acute peritonitis

    Time frame: day 3

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jan 7, 2010
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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