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

Completed

• Conditions: Shock; Aortic Valve Disease; Coronary Artery Disease; Mitral Valve Disease

• Registration Number: NCT06197321
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Study Timeline

• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-09
• Study Start: 2024-01-15
• Status Verified: 2024-09
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands