Non-invasive Prediction of Fluid and Noradrenaline Responsiveness Using the Carotid Wave Intensity.

Non-invasive Prediction of Fluid and Noradrenaline Responsiveness in Critical Care Patients Using the Carotid Wave Intensity (cWI)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06197321

Acronym

VACC

Enrollment

120

Registered

2024-01-09

Start date

2024-01-15

Completion date

2024-12-31

Last updated

2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Coronary Artery Disease, Mitral Valve Disease, Shock

Keywords

Ventriculo-arterial coupling, Carotid ultrasound

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The prediction of the hemodynamic response to norepinephrine or fluids using carotid ultrasound measurements.	Through study completion, an average of 1 year.	It will be studied if carotid ultrasound measurements can be used to predict a hemodynamic response to hemodynamic drugs, where the hemodynamic response is defined as a 15% increase in stroke volume.

Secondary

Measure	Time frame	Description
The concordance of ventricular-arterial coupling (VAC) measurements obtained using carotid ultrasound measurements with VAC measurements obtained using the single-beat method.	Through study completion, an average of 1 year.	The concordance between VAC measurements obtained using carotid ultrasound and VAC measurements obtained using the single-beat method will be assessed and quantified.

Countries

Netherlands

Outcome results