Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis

This study has been terminated.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00119990
First received: July 5, 2005
Last updated: December 5, 2008
Last verified: December 2008

July 5, 2005
December 5, 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00119990 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.
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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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00119990
AA20050009
No
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