Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis

Peritoneal Dialysis Clinical Trial

Official title:

Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00119990
• Other study ID #: AA20050009
• Status: Terminated
• Phase: N/A
• First received: July 5, 2005
• Last updated: December 5, 2008
• Start date: January 2006
• Est. completion date: January 2010

Study information

• Verified date: December 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peritoneal Dialysis

Intervention

Drug:
• Icodextrin (dialysate)
2 liter of extraneal are given with one fill for 4 hours.
• 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.

Locations

Country	Name	City	State
Denmark	Deparment of Renal Medicine, Skejby Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance)		4 hours	No