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

July 5, 2005
July 14, 2005
December 8, 2008
January 2006
January 2009   (Final data collection date for primary outcome measure)
Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance) [ Time Frame: 4 hours ]
Not Provided
Complete list of historical versions of study NCT00119990 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis
Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peritoneal Dialysis
  • 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.
Not Provided
Boon D, Bos WJ, van Montfrans GA, Krediet RT. Acute effects of peritoneal dialysis on hemodynamics. Perit Dial Int. 2001 Mar-Apr;21(2):166-71.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2010
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Per Ivarsen, MD, PhD, Departement of Renal Medicine, Aarhus Universityhospital, Skejb
University of Aarhus
Not Provided
Principal Investigator: Per Ivarsen Department of Renal Medicine C, Skejby Hospital, Denmark
University of Aarhus
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP