Clinical trial NCT06197321: Non-invasive Prediction of Fluid and Noradrenaline Responsiveness Using the Carotid Wave Intensity.
Official title: Non-invasive Prediction of Fluid and Noradrenaline Responsiveness in Critical Care Patients Using the Carotid Wave Intensity (cWI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock
Aortic Valve Disease
Coronary Artery Disease
Mitral Valve Disease
Keywords: Ventriculo-arterial coupling
Carotid ultrasound
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult ICU patients after cardiac surgery.

Brief summary: The goal of this observational study is to study a new method to compute ventricular-arterial coupling (VAC) in adult intensive care patients after cardiac surgery. VAC is a metric that describes the interaction between the heart and the arterial system. The new method of measuring VAC uses carotid ultrasound measurements. The main questions this study aims to answer are:

* Can VAC measured using carotid ultrasound predict the hemodynamic response to drugs?
* What is the concordance of VAC measurements obtained via carotid ultrasound with VAC measurements obtained via the standard, single-beat method? Measurements will be performed in the operating room and at the ICU.

Detailed description: The goal of this prospective observational study is to study ventricular-arterial coupling (VAC) measured using carotid ultrasound in adult intensive care patients after cardiac surgery. The objectives of this study are:

* To determine if VAC measured using carotid ultrasound can predict the hemodynamic response to drugs.
* To assess and quantify the concordance of VAC measurements obtained using carotid ultrasound with VAC measurements obtained using the single-beat method.

Measurements will be performed in the operating room and at the ICU.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years)
* Admitted to the ICU after cardiac surgery

Exclusion Criteria:

* No informed consent for study participation
* Within the first 3 hours of ICU admission noradrenaline infusion is not increased or started, and/or a fluid bolus is not given; both on indication of the attending physician
* Patient with chronic obstructive pulmonary disease (COPD) gold stage 3 or 4
* Pregnancy
* Moderate to severe aortic valve disease
* Atrial fibrillation
* Carotid artery stenosis \>50%
* History of cerebrovascular accident or transient ischemic attack
* History of cerebral trauma
* Morbid obesity (BMI \>40 kg/m2)
* Emergency surgery

Primary outcomes:
measure: The prediction of the hemodynamic response to norepinephrine or fluids using carotid ultrasound measurements.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: The concordance of ventricular-arterial coupling (VAC) measurements obtained using carotid ultrasound measurements with VAC measurements obtained using the single-beat method.
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: R. A. Bouwman, Prof.
role: STUDY_CHAIR
References: