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

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.

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Key information

Conditions

Shock Aortic Valve Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Mitral Valve Disease Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5652 EJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The prediction of the hemodynamic response to norepinephrine or fluids using carotid ultrasound measurements.

Time frame: 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 outcomes

The concordance of ventricular-arterial coupling (VAC) measurements obtained using carotid ultrasound measurements with VAC measurements obtained using the single-beat method.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

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

Acronym: VACC

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 9, 2024
Registry last updated: Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed