CompletedNot Applicable

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

Netherlands120 participantsStarted 2024-01-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Through study completion, an average of 1 year.

Trial details

NCT IDNCT06197321

SponsorCatharina Ziekenhuis Eindhoven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11-30

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