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

NCT06197321 | Completed

• 1 other identifier: nWMO-2023.131
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Aortic Valve Disease; Coronary Artery Disease; Mitral Valve Disease

Keywords

Ventriculo-arterial coupling; Carotid ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult ICU patients after cardiac surgery.

You may qualify if:

• Adult patients (≥18 years)
• Admitted to the ICU after cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Ziekenhuis

Eindhoven, North Brabant, 5652 EJ, Netherlands

Location

MeSH Terms

Conditions

Shock; Aortic Valve Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• R. A. Bouwman, Prof.

  Catharina Ziekenhuis Eindhoven

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 9, 2024
• Study Start: January 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 18, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)