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Measuring Cardiovascular Stress in Patients on Hemodialysis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by West Penn Allegheny Health System.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01267617
First Posted: December 28, 2010
Last Update Posted: December 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
West Penn Allegheny Health System
  Purpose
To determine if proprietary software that uses pulse-wave analysis to interpret the output of a conventional pulse-oximeter, can predict the onset of circulatory stress, before changes in blood pressure and pulse occur, in patients undergoing outpatient hemodialysis.

Condition
Hemodialysis Hypotension Circulatory Stress Photo-plethysmography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Cardiovascular Stress in Patients on Hemodialysis

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • photoplethysmography [ Time Frame: 5 hours ]
    Pulse-wave analysis of an oximeter signal


Secondary Outcome Measures:
  • blood pressure [ Time Frame: 5 hours ]
    measured continuously during treatment


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
chronic hemodialysis outpatients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients receiving hemodialysis at a single center
Criteria

Inclusion Criteria:

  • Patients having regular outpatient dialysis treatments
  • Patients who are willing and able to provide informed consent

Exclusion Criteria:

  • Patients who do not wish to participate
  • Patients with contraindications to attachment of monitoring devices
  • Patients with skin rash or hypersensitivity to the adhesive sensors
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267617


Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
Principal Investigator: Rita L McGill, MD West Penn Allegheny Health System
  More Information

Responsible Party: Rita L. McGill MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT01267617     History of Changes
Other Study ID Numbers: RC-5046
First Submitted: December 23, 2010
First Posted: December 28, 2010
Last Update Posted: December 28, 2010
Last Verified: December 2010

Keywords provided by West Penn Allegheny Health System:
hemodialysis
hypotension
circulatory stress
photo-plethysmography

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases