HemodialysisNCT01267617
Measuring Cardiovascular Stress in Patients on Hemodialysis
An observational study of Hemodialysis and Hypotension, run by West Penn Allegheny Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Hypotension, Circulatory Stress
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2010to 14 Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients receiving hemodialysis at a single center
Who may be able to join
- Patients having regular outpatient dialysis treatments
- Patients who are willing and able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
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.
- Conditions
- Hemodialysis, Hypotension, Circulatory Stress, Photo-plethysmography
- Keywords
- hemodialysis, hypotension, circulatory stress, photo-plethysmography
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic hemodialysis outpatients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
photoplethysmography
Pulse-wave analysis of an oximeter signal
Measured: 5 hours
Secondary outcomes (1)
blood pressure
measured continuously during treatment
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study start30 Nov 2010
- Primary completion14 Nov 2011
- Study completion14 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Investigators
- Rita L McGill, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267617
- Sponsor's protocol ID
- RC-5046
- Status last verified
- Aug 2020
- First submitted
- 23 Dec 2010
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cardiovascular Stress in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT01267617
- Acronym / sponsor ID
- RC-5046
- Conditions
- Hemodialysis, Hypotension, Circulatory Stress, Photo-plethysmography
- Keywords
- hemodialysis, hypotension, circulatory stress, photo-plethysmography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Study start
- 30 Nov 2010 (actual)
- Primary completion
- 14 Nov 2011 (actual)
- Study completion
- 14 Nov 2011 (actual)
- First posted
- 28 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic hemodialysis outpatients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients receiving hemodialysis at a single center
Key inclusion criteria (2 listed)
- Patients having regular outpatient dialysis treatments
- Patients who are willing and able to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
photoplethysmography
Time frame: 5 hours
Pulse-wave analysis of an oximeter signal
1 secondary outcome
blood pressure
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita L McGill, MD principal investigator
West Penn Allegheny Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis and Hypotension, run by West Penn Allegheny Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
photoplethysmography (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.