We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00119990
First Posted: July 14, 2005
Last Update Posted: December 8, 2008
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.
Information provided by:
University of Aarhus
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00119990


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

Publications:
Responsible Party: Per Ivarsen, MD, PhD, Departement of Renal Medicine, Aarhus Universityhospital, Skejb
ClinicalTrials.gov Identifier: NCT00119990     History of Changes
Other Study ID Numbers: AA20050009
First Submitted: July 5, 2005
First Posted: July 14, 2005
Last Update Posted: December 8, 2008
Last Verified: December 2008

Keywords provided by University of Aarhus:
vasopressin
icodextrin
cardiac output

Additional relevant MeSH terms:
Dialysis Solutions
Icodextrin
Pharmaceutical Solutions