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

Coronary Artery Disease Clinical Trial

— VACC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197321
• Other study ID #: nWMO-2023.131
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Catharina Ziekenhuis Eindhoven
• Contact: Esmée C. de Boer, MSc.
• Phone: +31649620245
• Email: esmee.d.boer[@]catharinaziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Coronary Artery Disease
• Mitral Valve Disease
• Shock

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prediction of the hemodynamic response to norepinephrine or fluids using carotid ultrasound measurements.	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.	Through study completion, an average of 1 year.
Secondary	The concordance of ventricular-arterial coupling (VAC) measurements obtained using carotid ultrasound measurements with VAC measurements obtained using the single-beat method.	The concordance between VAC measurements obtained using carotid ultrasound and VAC measurements obtained using the single-beat method will be assessed and quantified.	Through study completion, an average of 1 year.