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

  • Denmark
      • 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

University of Aarhus

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.

General Publications

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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