Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00119990

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:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Icodextrin Physioneal

U.S. FDA Resources

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:

2 liter of extraneal are given with one fill for 4 hours.

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

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:

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.

Responsible Party:	Departement of Renal Medicine, Aarhus Universityhospital, Skejb ( Per Ivarsen, MD, PhD )
Study ID Numbers:	AA20050009
Study First Received:	July 5, 2005
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00119990 History of Changes
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

vasopressin
icodextrin
cardiac output

Study placed in the following topic categories:

Arginine Vasopressin
Vasopressins

ClinicalTrials.gov processed this record on September 09, 2009