SepsisNCT03621618
Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.
A study testing dobutamine and norepinephrine in people with Sepsis and Cardiac Failure Acute, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The primary goal of the study is to determine Eadyn ( = PPV/SVV) as a functional measure of arterial load, in conjunction with other actual afterload indices, systemic vascular resistance and arterial elastance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis, Cardiac Failure Acute
- What is being tested?
- dobutamine and norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2019to 2 Jun 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients, treated/supported with noradrenalin or dobutamine.
Who cannot join
- Septic shock
- Aortic valve regurgitation and defect of septum
- Severe aortic sclerosis, aortic prosthesis
- Severe hypertension (MAP > 130 mmHg)
- Cardiac arrhythmia
- Tachycardia with a heart rate higher than 150 bpm
Show all 10Show fewer
- Age below 18 or above 75 y
- Patient height below 120 cm (48") or above 230 cm (90")
- Patient weight less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)
- Intra-aortic balloon pump
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal of the study is to determine Eadyn ( = PPV/SVV) as a functional measure of arterial load, in conjunction with other actual afterload indices, systemic vascular resistance and arterial elastance. A secondary aim is the assessment of the influences of vasopressors and inotropic drugs on Eadyn, as a parameter of ventriculo-arterial coupling.
Read the detailed description
Assessment of the cardiovascular status and haemodynamics comprise directly or indirectly cardiac output, which is determined by left ventricular preload, contractility, afterload and heart rate. Various haemodynamic monitors have been introduced in anaesthesia and ICU practice, providing cardiac output either non-invasively or invasively. The combined use of arterial pressure monitoring with these devices provides insight not only in cardiac output but offers bedside assessment of most determinants of cardiovascular function. Both pulse pressure variation (PPV) and stroke volume variation (SVV) have been described as dynamic descriptors of fluid responsiveness, a measure allowing optimization of preloading conditions if haemodynamics show signals of insufficient perfusion.
Arterial load can be assessed based on a two-element Windkessel model with a static and dynamic component. The static part consists of a resistive element (systemic vascular resistance: SVR = (MAP/C0)*80, with MAP, mean arterial pressure; CO, cardiac output) and a pulsatile component (net arterial compliance C = SV/arterial pulse pressure with SV, stroke volume). Arterial elastance is considered being an integrative variable, associating both steady elements and heart rate (Ea = .9*SAP/SV with EA, arterial elastance; SAP, systolic arterial pressure). The dynamic component Eadyn is the ratio of PPV and SVV during a mechanical ventilator cycle, providing a functional assessment of ventriculo-arterial coupling.
Combined use of arterial pressure tracing (or its non-invasive surrogate) and (non-) invasive stroke volume actually may provide an interesting framework for haemodynamic monitoring and subsequent optimization in many surgical, postoperative or ICU patients. This study aims to copy as good as possible the handling and the way of management as in a clinical setting.
- Conditions
- Sepsis, Cardiac Failure Acute
- Being tested
- dobutamine, norepinephrine
- Keywords
- vasoactive medication, dynamic arterial elastance
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dobutamineDiagnostic test
evaluation of effects of dobutamine on dynamic arterial elastance in cardiac failure
norepinephrineDiagnostic test
evaluation of effects of norepinephrine on dynamic arterial elastance in sepsis
| Study group | Role | What they receive |
|---|---|---|
| dobutamine | Other | Cardiac failure Receives: Diagnostic Test: dobutamine |
| norepinephrine | Other | Sepsis Receives: Diagnostic Test: norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Dynamic Arterial Elastance (Eadyn)
display on the hemodynamic monitor
Measured: baseline and from 30-90 minutes after increase with 20% of vasoactive medication and haemodynamic stabilisation
Secondary outcomes (1)
Eadyn estimation on haemodynamic monitor
display on the hemodynamic monitor
Measured: from 30 to 90 minutes after increase with 20% of vasoactive medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start31 Mar 2019
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Why it stopped: COVID-19 + not enough resources available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Poelaert, PhD, MD, Principal investigator, Universitair Ziekenhuis BrusselMichel Vervoort, IR, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621618
- Sponsor's protocol ID
- Eadyn project 2
- Status last verified
- Oct 2025
- First submitted
- 28 Jun 2018
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.
- ClinicalTrials.gov ID
- NCT03621618
- Acronym / sponsor ID
- Eadyn project 2
- Conditions
- Sepsis, Cardiac Failure Acute
- Keywords
- vasoactive medication, dynamic arterial elastance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 + not enough resources available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 8 Aug 2018 (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.
The primary goal of the study is to determine Eadyn ( = PPV/SVV) as a functional measure of arterial load, in conjunction with other actual afterload indices, systemic vascular resistance and arterial elastance. A secondary aim is the assessment of the influences of vasopressors and inotropic drugs on Eadyn, as a parameter of ventriculo-arterial coupling.
Detailed description
Assessment of the cardiovascular status and haemodynamics comprise directly or indirectly cardiac output, which is determined by left ventricular preload, contractility, afterload and heart rate. Various haemodynamic monitors have been introduced in anaesthesia and ICU practice, providing cardiac output either non-invasively or invasively. The combined use of arterial pressure monitoring with these devices provides insight not only in cardiac output but offers bedside assessment of most determinants of cardiovascular function. Both pulse pressure variation (PPV) and stroke volume variation (SVV) have been described as dynamic descriptors of fluid responsiveness, a measure allowing optimization of preloading conditions if haemodynamics show signals of insufficient perfusion.
Arterial load can be assessed based on a two-element Windkessel model with a static and dynamic component. The static part consists of a resistive element (systemic vascular resistance: SVR = (MAP/C0)*80, with MAP, mean arterial pressure; CO, cardiac output) and a pulsatile component (net arterial compliance C = SV/arterial pulse pressure with SV, stroke volume). Arterial elastance is considered being an integrative variable, associating both steady elements and heart rate (Ea = .9*SAP/SV with EA, arterial elastance; SAP, systolic arterial pressure). The dynamic component Eadyn is the ratio of PPV and SVV during a mechanical ventilator cycle, providing a functional assessment of ventriculo-arterial coupling.
Combined use of arterial pressure tracing (or its non-invasive surrogate) and (non-) invasive stroke volume actually may provide an interesting framework for haemodynamic monitoring and subsequent optimization in many surgical, postoperative or ICU patients. This study aims to copy as good as possible the handling and the way of management as in a clinical setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dobutamine | Other | Diagnostic Test: dobutamineCardiac failure |
| norepinephrine | Other | Diagnostic Test: norepinephrineSepsis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients, treated/supported with noradrenalin or dobutamine.
Key exclusion criteria (10 listed)
- Septic shock
- Aortic valve regurgitation and defect of septum
- Severe aortic sclerosis, aortic prosthesis
- Severe hypertension (MAP > 130 mmHg)
- Cardiac arrhythmia
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 |
|---|---|---|
| dobutamineevaluation of effects of dobutamine on dynamic arterial elastance in cardiac failure | Diagnostic test | dobutamine |
| norepinephrineevaluation of effects of norepinephrine on dynamic arterial elastance in sepsis | Diagnostic test | norepinephrine |
Primary outcome
Change of Dynamic Arterial Elastance (Eadyn)
Time frame: baseline and from 30-90 minutes after increase with 20% of vasoactive medication and haemodynamic stabilisation
display on the hemodynamic monitor
1 secondary outcome
Eadyn estimation on haemodynamic monitor
Time frame: from 30 to 90 minutes after increase with 20% of vasoactive medication
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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.
Jan Poelaert, PhD, MD principal investigator
Universitair Ziekenhuis Brussel
Michel Vervoort, IR study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dobutamine and norepinephrine in people with Sepsis and Cardiac Failure Acute, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 18 Nov 2025. 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 Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change of Dynamic Arterial Elastance (Eadyn) (time frame: baseline and from 30-90 minutes after increase with 20% of vasoactive medication and haemodynamic stabilisation). 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 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.