- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119990
Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis
December 5, 2008 updated by: University of Aarhus
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aarhus, Denmark, 8200
- Deparment of Renal Medicine, Skejby Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance)
Time Frame: 4 hours
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Per Ivarsen, Department of Renal Medicine C, Skejby Hospital, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Anticipated)
January 1, 2009
Study Completion (Anticipated)
January 1, 2010
Study Registration Dates
First Submitted
July 5, 2005
First Submitted That Met QC Criteria
July 5, 2005
First Posted (Estimate)
July 14, 2005
Study Record Updates
Last Update Posted (Estimate)
December 8, 2008
Last Update Submitted That Met QC Criteria
December 5, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA20050009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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