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Measuring Cardiovascular Stress in Patients on Hemodialysis

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ClinicalTrials.gov Identifier: NCT01267617
Recruitment Status : Unknown
Verified December 2010 by West Penn Allegheny Health System.
Recruitment status was:  Enrolling by invitation
First Posted : December 28, 2010
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
West Penn Allegheny Health System

Brief Summary:
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 or disease
Hemodialysis Hypotension Circulatory Stress Photo-plethysmography

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Cardiovascular Stress in Patients on Hemodialysis
Study Start Date : November 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort
chronic hemodialysis outpatients



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


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: December 28, 2010    Key Record Dates
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