Heart DiseasesNCT04745845
The Impact of Noradrenaline on Ventriculo-arterial Coupling and Central Cardiovascular Energy Delivery
A study testing Noradrenalin in people with Heart Diseases, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The study aims to examine how noradrenaline in combination with venous return influences the energy transmission from heart to central circulation and arteries - also called arterio-ventricular coupling. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Noradrenalin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2021to 31 Dec 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective coronary artery bypass graft surgery
- requirement for Noradrenaline/Norepinephrine
Who cannot join
- lack of informed consent
- patient unsuitable for mean arterial pressure (MAP) elevation of 20mmHg
- patient requiring different blood pressure range due to medical/surgical needs
- poor image quality due to patient factors
Trial locations and contacts
1 site in 1 country.
Norway1 site
St Olavs Hospital, Dep. for Anesthesia & Intensive care. Section of cardiothoracic Anesthesia and -intensive Care.
Trondheim, 7006
About this study
The study aims to examine how noradrenaline in combination with venous return influences the energy transmission from heart to central circulation and arteries - also called arterio-ventricular coupling.
Read the detailed description
After being informed about the study 40 elective CABG patients with written informed consent will undergo assessment of their arterio-ventricular coupling postoperatively after coronary bypass graft surgery. Whilst still in deep general anesthesia on the CT ICU the study population will be assessed by echocardiographic examination (transthoracic and transesophageal), blood pressure tracing by arterial line, respiratory data and ECG in 4 different situations.
Initially the individual patient is either considered fluid responsive (SVV >13%) og non- responsive (SVV<13%) by using stroke volume variation assessed by echocardiography.
In case of fluid responsiveness a fluid bolus of 4ml/kg of crystalloid fluid is given until SVV drops below 13% and the patient can be considered as fluid NON responder.
Right afterwards the study patient is stabilized with a baseline dose of noradrenaline (NA) intravenously in a supine position (situation 1). Situation 2 will be a slight increase in NA dose stabilizing mean arterial pressure in a "baseline + 20mmHg" state. After reversing the NA dose back to base line level the patient is allowed a short period of rest to wean of drug effect (4-5 x t1/2, appr. 12min). Subsequently the patient is to be placed in a 20% semi upright position (Anti-Trendelenburg) causing an increase in fluid responsiveness (situation 3). Following a phase of equilibration the dose of NA is again titrated up to obtain a 20mmHg increase in mean arterial pressure (situation 4).
There will be logging of arterial pressure curve and VTI-tracing I LVOT simultaneously (ultrapower, uPWR) as well as calculation of energy delivery, cardiac power, oscillatory power and -fraction and both arterial and ventricular elastance in every of those 4 situations.
- Conditions
- Heart Diseases
- Being tested
- Noradrenalin
- Keywords
- Noradrenaline, Heart surgery, Intensive care, Cardiac physiology
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoradrenalinProcedure or surgery
Also called Anti-Trendelenburg position/Semiupright position (20degr)
Norepinephrine challenge (concentration 'A' ) in fluid responsive position
NoradrenalinProcedure or surgery
Also called supine position
Norepinephrine challenge (concentration 'A') in non-fluid responsive position
NoradrenalinProcedure or surgery
Also called Anti-Trendelenburg position/Semiupright position (20degr)
Norepinephrine challenge (concentration 'B') in fluid responsive position
NoradrenalinProcedure or surgery
Also called supine position
Norepinephrine challenge (concentration 'B') in non-fluid responsive position
| Study group | Role | What they receive |
|---|---|---|
| Noradrenalin | Experimental | treatment with 2 different NA concentrations in 2 different states of fluid responsiveness Receives: Procedure: Noradrenalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiac Power
Change in Cardiac Power in reaction to both different noradrenaline doses and states of fluid responsiveness.
By logging invasive BP curve and tracing left ventricular outflow tract Velocity Time Integral (by echocardiography) simultaneously Total and Mean Cardiac Power (Watt) can be determined. Examining the response to different NA doses relative to fluid responsiveness the effect of NA on arterio-ventricular coupling can be examined.
Measured: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
Change in Oscillatory Power Fraction
Change in Oscillatory Power Fraction (OPF) in reaction to both different noradrenaline doses and states of fluid responsiveness.
By logging invasive BP curve and tracing left ventricular outflow tract Velocity Time Integral (by echocardiography) simultaneously Total Cardiac Power (TCP, Watt) and Cardiac Power Output (CPO, Watt) can be determined. By subtracting CPO from TCP, OPF (in %) can be calculated. Examining the response to different NA doses relative to fluid responsiveness the effect of NA on arterio-ventricular coupling can be examined.
Measured: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
Secondary outcomes (2)
Change in single beat ventricular elastance
Change in single beat ventricular elastance in reaction to both different noradrenaline doses and states of fluid responsiveness.
Ventricular elastance (Ees) can be determined on the bedside by using a single beat measurement of left ventricular ejection fraction, stroke volume, preejection time and ejection time.
Measured: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
Change in single beat arterial elastance
Change in single beat arterial elastance in reaction to both different noradrenaline doses and states of fluid responsiveness. Using an estimative formula Ea can be calculated (Ea=SBPx0.9/SV) and Ea/Ees as a marker of arterio-ventricular coupling can be evaluated.
Measured: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilde Pleym (Head of Department), md, PhD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745845
- Sponsor's protocol ID
- 2019/287
- Status last verified
- Jan 2022
- First submitted
- 8 Feb 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Noradrenaline on Ventriculo-arterial Coupling and Central Cardiovascular Energy Delivery
- ClinicalTrials.gov ID
- NCT04745845
- Acronym / sponsor ID
- 2019/287
- Conditions
- Heart Diseases
- Keywords
- Noradrenaline, Heart surgery, Intensive care, Cardiac physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Feb 2021 (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 study aims to examine how noradrenaline in combination with venous return influences the energy transmission from heart to central circulation and arteries - also called arterio-ventricular coupling.
Detailed description
After being informed about the study 40 elective CABG patients with written informed consent will undergo assessment of their arterio-ventricular coupling postoperatively after coronary bypass graft surgery. Whilst still in deep general anesthesia on the CT ICU the study population will be assessed by echocardiographic examination (transthoracic and transesophageal), blood pressure tracing by arterial line, respiratory data and ECG in 4 different situations.
Initially the individual patient is either considered fluid responsive (SVV >13%) og non- responsive (SVV<13%) by using stroke volume variation assessed by echocardiography.
In case of fluid responsiveness a fluid bolus of 4ml/kg of crystalloid fluid is given until SVV drops below 13% and the patient can be considered as fluid NON responder.
Right afterwards the study patient is stabilized with a baseline dose of noradrenaline (NA) intravenously in a supine position (situation 1). Situation 2 will be a slight increase in NA dose stabilizing mean arterial pressure in a "baseline + 20mmHg" state. After reversing the NA dose back to base line level the patient is allowed a short period of rest to wean of drug effect (4-5 x t1/2, appr. 12min). Subsequently the patient is to be placed in a 20% semi upright position (Anti-Trendelenburg) causing an increase in fluid responsiveness (situation 3). Following a phase of equilibration the dose of NA is again titrated up to obtain a 20mmHg increase in mean arterial pressure (situation 4).
There will be logging of arterial pressure curve and VTI-tracing I LVOT simultaneously (ultrapower, uPWR) as well as calculation of energy delivery, cardiac power, oscillatory power and -fraction and both arterial and ventricular elastance in every of those 4 situations.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noradrenalin | Experimental | Procedure: Noradrenalintreatment with 2 different NA concentrations in 2 different states of fluid responsiveness |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective coronary artery bypass graft surgery
- requirement for Noradrenaline/Norepinephrine
Key exclusion criteria (4 listed)
- lack of informed consent
- patient unsuitable for mean arterial pressure (MAP) elevation of 20mmHg
- patient requiring different blood pressure range due to medical/surgical needs
- poor image quality due to patient factors
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 |
|---|---|---|
| NoradrenalinAlso: Anti-Trendelenburg position/Semiupright position (20degr)Norepinephrine challenge (concentration 'A' ) in fluid responsive position | Procedure or surgery | Noradrenalin |
| NoradrenalinAlso: supine positionNorepinephrine challenge (concentration 'A') in non-fluid responsive position | Procedure or surgery | Noradrenalin |
| NoradrenalinAlso: Anti-Trendelenburg position/Semiupright position (20degr)Norepinephrine challenge (concentration 'B') in fluid responsive position | Procedure or surgery | Noradrenalin |
| NoradrenalinAlso: supine positionNorepinephrine challenge (concentration 'B') in non-fluid responsive position | Procedure or surgery | Noradrenalin |
Primary outcome
Change in Cardiac Power
Time frame: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
Change in Cardiac Power in reaction to both different noradrenaline doses and states of fluid responsiveness. By logging invasive BP curve and tracing left ventricular outflow tract Velocity Time Integral (by echocardiography) simultaneously Total and Mean Cardiac Power (Watt) can be determined. Examining the response to different NA doses relative to fluid responsiveness the effect of NA on arterio-ventricular coupling can be examined.
Change in Oscillatory Power Fraction
Time frame: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
Change in Oscillatory Power Fraction (OPF) in reaction to both different noradrenaline doses and states of fluid responsiveness. By logging invasive BP curve and tracing left ventricular outflow tract Velocity Time Integral (by echocardiography) simultaneously Total Cardiac Power (TCP, Watt) and Cardiac Power Output (CPO, Watt) can be determined. By subtracting CPO from TCP, OPF (in %) can be calculated. Examining the response to different NA doses relative to fluid responsiveness the effect of NA on arterio-ventricular coupling can be examined.
2 secondary outcomes
Change in single beat ventricular elastance
Time frame: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
Change in single beat arterial elastance
Time frame: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
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 5 Jan 2022.
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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.
Hilde Pleym (Head of Department), md, PhD study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noradrenalin in people with Heart Diseases, run by St. Olavs Hospital at 1 site in Norway.
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 4 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 5 Jan 2022. 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 Norway. 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?
Change in Cardiac Power (time frame: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery). The study lists 2 primary outcomes in all. 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 5 Jan 2022.