Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis

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: NCT00119990
Recruitment Status : Terminated
First Posted : July 14, 2005
Last Update Posted : December 8, 2008
Information provided by:
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment Phase
Peritoneal Dialysis Drug: Icodextrin (dialysate) Drug: Physioneal (dialysate) 1.36% and 2.27% Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Study Start Date : January 2006
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Icodextrin
U.S. FDA Resources

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.

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

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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

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): 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

Responsible Party: Per Ivarsen, MD, PhD, Departement of Renal Medicine, Aarhus Universityhospital, Skejb Identifier: NCT00119990     History of Changes
Other Study ID Numbers: AA20050009
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: December 8, 2008
Last Verified: December 2008

Keywords provided by University of Aarhus:
cardiac output

Additional relevant MeSH terms:
Dialysis Solutions
Pharmaceutical Solutions