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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06197321
Other study ID # nWMO-2023.131
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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