Cardiac OutputNCT03900546
Arterial Tone Influence on Cardiac Output Measured by PRAM
An observational study of Cardiac Output and Critically Ill, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
This study evaluates the role of arterial tone in the accuracy of cardiac output (CO) measurement by Pressure Recording Analytical Method (PRAM). Patients receiving noradrenaline who need for clinical reason to change the noradrenaline dose will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Critically Ill
- What is being tested?
- MostCare
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Feb 2020
- 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: Critically ill patients admitted to intensive care unit that need variation of noradrenaline dose for clinical reason.
Who may be able to join
- invasive blood pressure monitoring on site
- need to start or change the dose of noradrenaline infusion for clinical reason
Who cannot join
- age <18
- arrhythmia
- severe valvular insufficiency
- pregnancy
- low quality arterial signal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Arterial Tone Changes on Cardiac Output Measurement by Pressure Recording Analytical Method
This study evaluates the role of arterial tone in the accuracy of cardiac output (CO) measurement by Pressure Recording Analytical Method (PRAM). Patients receiving noradrenaline who need for clinical reason to change the noradrenaline dose will be enrolled. We use echocardiography as reference method of CO measurement.
Read the detailed description
Pressure Recording Analytical Method (PRAM) is an arterial pulse contour analysis method for CO measurement. As it is an uncalibrated method, one possible reason for its inaccuracy is rapid changes in arterial tone.
- Conditions
- Cardiac Output, Critically Ill
- Being tested
- MostCare
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MostCareDevice
CO measurement using echocardiography and PRAM before and after noradrenaline dose change due to clinical reason
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM
Agreement between echocardiography and PRAM in CO measurement during arterial tone changes induced by different dose of noradrenaline
Measured: Before and 30 minutes after noradrenaline dose variation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study startMar 2014
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abele Donati, MD, Università Politecnica delle Marche
- Investigators
- Abele Donati, MD, PhD, Principal investigator, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900546
- Sponsor's protocol ID
- PRAM
- Status last verified
- Mar 2020
- First submitted
- 29 Mar 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Arterial Tone Changes on Cardiac Output Measurement by Pressure Recording Analytical Method
- ClinicalTrials.gov ID
- NCT03900546
- Acronym / sponsor ID
- PRAM
- Conditions
- Cardiac Output, Critically Ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 3 Apr 2019 (actual)
- 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.
This study evaluates the role of arterial tone in the accuracy of cardiac output (CO) measurement by Pressure Recording Analytical Method (PRAM). Patients receiving noradrenaline who need for clinical reason to change the noradrenaline dose will be enrolled. We use echocardiography as reference method of CO measurement.
Detailed description
Pressure Recording Analytical Method (PRAM) is an arterial pulse contour analysis method for CO measurement. As it is an uncalibrated method, one possible reason for its inaccuracy is rapid changes in arterial tone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to intensive care unit that need variation of noradrenaline dose for clinical reason.
Key inclusion criteria (2 listed)
- invasive blood pressure monitoring on site
- need to start or change the dose of noradrenaline infusion for clinical reason
Key exclusion criteria (5 listed)
- age <18
- arrhythmia
- severe valvular insufficiency
- pregnancy
- low quality arterial signal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MostCareCO measurement using echocardiography and PRAM before and after noradrenaline dose change due to clinical reason | Device | – |
Primary outcome
Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM
Time frame: Before and 30 minutes after noradrenaline dose variation
Agreement between echocardiography and PRAM in CO measurement during arterial tone changes induced by different dose of noradrenaline
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 25 Mar 2020.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Abele Donati, MD, PhD principal investigator
Università Politecnica delle Marche
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 Cardiac Output and Critically Ill, run by Università Politecnica delle Marche at 1 site in Italy.
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 5 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 25 Mar 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 Italy. 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?
Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM (time frame: Before and 30 minutes after noradrenaline dose variation). 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 25 Mar 2020.