Viewing Study NCT04745845



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Last Modification Date: 2024-10-26 @ 1:56 PM
Study NCT ID: NCT04745845
Status: COMPLETED
Last Update Posted: 2022-01-05
First Post: 2021-02-08

Brief Title: The Impact of Noradrenaline on Ventriculo-arterial Coupling and Central Cardiovascular Energy Delivery
Sponsor: St Olavs Hospital
Organization: St Olavs Hospital

Study Overview

Official Title: The Impact of Noradrenaline on Ventriculo-arterial Coupling and Central Cardiovascular Energy Delivery
Status: COMPLETED
Status Verified Date: 2022-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 SVV13 by using stroke volume variation assessed by echocardiography

In case of fluid responsiveness a fluid bolus of 4mlkg 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 t12 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None