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Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis

This study has been terminated.
Information provided by:
University of Aarhus Identifier:
First received: July 5, 2005
Last updated: December 5, 2008
Last verified: December 2008
During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood pressure has been described. The effect upon central hemodynamics is unknown. The researchers are investigating the effects of low and high glucose dialysate and icodextrin on cardiac output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that the effects seen are induced by vasopressin.

Condition Intervention
Peritoneal Dialysis Drug: Icodextrin (dialysate) Drug: Physioneal (dialysate) 1.36% and 2.27%

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance) [ Time Frame: 4 hours ]

Estimated Enrollment: 15
Study Start Date: January 2006
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Icodextrin (dialysate)
    2 liter of extraneal are given with one fill for 4 hours.
    Drug: Physioneal (dialysate) 1.36% and 2.27%
    2 liter of Physioneal of 1.36% or 3.86% are given with one fill for 4 hours one two different days.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Peritoneal dialysis patients

Exclusion Criteria:

  • Insulin dependent diabetes mellitus
  • AV-fistula, cardial arrhythmia persistence, or severe cardiac and lung disease
  • Recent infectious disease
  • Severe psychiatric disease
  • Hypersensitivity to icodextrin
  Contacts and Locations
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Please refer to this study by its identifier: NCT00119990

Deparment of Renal Medicine, Skejby Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Per Ivarsen Department of Renal Medicine C, Skejby Hospital, Denmark
  More Information

Responsible Party: Per Ivarsen, MD, PhD, Departement of Renal Medicine, Aarhus Universityhospital, Skejb Identifier: NCT00119990     History of Changes
Other Study ID Numbers: AA20050009
Study First Received: July 5, 2005
Last Updated: December 5, 2008

Keywords provided by University of Aarhus:
cardiac output

Additional relevant MeSH terms:
Dialysis Solutions
Pharmaceutical Solutions processed this record on August 18, 2017