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

NCT ID: NCT06197321

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Shock Aortic Valve Disease Coronary Artery Disease Mitral Valve Disease

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Frederique de Raat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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R. A. Bouwman, Prof.

Role: STUDY_CHAIR

Catharina Ziekenhuis Eindhoven

Locations

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Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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nWMO-2023.131

Identifier Type: -

Identifier Source: org_study_id

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