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

February 14, 2025 updated by: Frederique de Raat, Catharina Ziekenhuis Eindhoven

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5652 EJ
        • Catharina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult ICU patients after cardiac surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prediction of the hemodynamic response to norepinephrine or fluids using carotid ultrasound measurements.
Time Frame: 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.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The concordance of ventricular-arterial coupling (VAC) measurements obtained using carotid ultrasound measurements with VAC measurements obtained using the single-beat method.
Time Frame: 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.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Investigators

  • Study Chair: R. A. Bouwman, Prof., Catharina Ziekenhuis Eindhoven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nWMO-2023.131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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