Measuring Cardiovascular Stress in Patients on Hemodialysis | NCT01267617

Studies
Measuring Cardiovascular Stress in Patients on Hemodialysis

NCT01267617

Sponsor

West Penn Allegheny Health System

Status

Completed

Last Update Posted

Aug 18, 2020Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Hemodialysis
Hypotension
Circulatory Stress
Photo-plethysmography

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2010Actual

Primary Completion Date

Nov 14, 2011Actual

Completion Date

Nov 14, 2011Actual

First Submitted Date

Dec 23, 2010

First Submission Date that Met QC Criteria

Dec 27, 2010

First Posted Date

Dec 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2020

Last Update Posted Date

Aug 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Label	Type	Description	Intervention Names
chronic hemodialysis outpatients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
photoplethysmography	Pulse-wave analysis of an oximeter signal	5 hours

Secondary Outcomes

Measure	Description	Time Frame
blood pressure	measured continuously during treatment	5 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatients receiving hemodialysis at a single center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rita L McGill, MD	West Penn Allegheny Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allegheny General Hospital		Pittsburgh	Pennsylvania	15212	United States

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided