An interventional study of Noradrenalin and Noradrenalin in Heart Diseases, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Basic science
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.
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.
3,674 studies on the registry are indexed under Heart Diseases; 458 are open to participants now.
This study's enrollment of 49 is below the median of 100 across 1,785 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
treatment with 2 different NA concentrations in 2 different states of fluid responsiveness
Procedure: Noradrenalin
Norepinephrine challenge (concentration 'A' ) in fluid responsive position
Also known as: Anti-Trendelenburg position/Semiupright position (20degr)
Norepinephrine challenge (concentration 'A') in non-fluid responsive position
Also known as: supine position
Norepinephrine challenge (concentration 'B') in fluid responsive position
Also known as: Anti-Trendelenburg position/Semiupright position (20degr)
Norepinephrine challenge (concentration 'B') in non-fluid responsive position
Also known as: supine position
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.
Time frame: 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.
Time frame: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
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.
Time frame: 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.
Time frame: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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