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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 5, 2005
Last Updated: December 5, 2008
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
vasopressin
icodextrin
cardiac output

Additional relevant MeSH terms:
Dialysis Solutions
Icodextrin
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014