Measuring Cardiovascular Stress in Patients on Hemodialysis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT01267617
First received: December 23, 2010
Last updated: December 27, 2010
Last verified: December 2010
  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 ] [ Designated as safety issue: No ]
    Pulse-wave analysis of an oximeter signal


Secondary Outcome Measures:
  • blood pressure [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rita L. McGill MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT01267617     History of Changes
Other Study ID Numbers: RC-5046
Study First Received: December 23, 2010
Last Updated: December 27, 2010
Health Authority: United States: Institutional Review Board
United States: West Penn Allegheny Health System (WPAHS Compliance Office)
United States: Allegheny-Singer Research Institute
United States: U.S. Food & Drug Administration
United States: Department of Health & Human Services

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

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014