NCT01267617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2011

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

December 23, 2010

Last Update Submit

August 17, 2020

Conditions

HemodialysisHypotensionCirculatory StressPhoto-plethysmography

Keywords

hemodialysishypotensioncirculatory stressphoto-plethysmography

Outcome Measures

Primary Outcomes (1)

  • photoplethysmography

    Pulse-wave analysis of an oximeter signal

    5 hours

Secondary Outcomes (1)

  • blood pressure

    5 hours

Study Arms (1)

chronic hemodialysis outpatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients receiving hemodialysis at a single center

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Rita L McGill, MD

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 28, 2010

Study Start

November 30, 2010

Primary Completion

November 14, 2011

Study Completion

November 14, 2011

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

US(1)