Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Measuring Cardiovascular Stress in Patients on Hemodialysis

This study is enrolling participants by invitation only.
Information provided by:
West Penn Allegheny Health System Identifier:
First received: December 23, 2010
Last updated: December 27, 2010
Last verified: December 2010

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.

Circulatory Stress

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)
chronic hemodialysis outpatients


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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01267617

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
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 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:
circulatory stress
photo-plethysmography processed this record on February 27, 2015