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NCT Number: NCT07256886

Validation of the iCVS Model in Patients Admitted to the Intensive Care Unit

One of the significant challenges in the care of critically ill patients in the intensive care unit is the assessment of hemodynamically unstable patients (shock states). The treating team uses data such as heart rate, arterial blood pressure, physical examination findings, etc. to assess the patient's cardiac output, peripheral vascular resistance, filling pressures and volumes, and vascular tone. These assessments are essential to assess the cause of shock (cardiac cause, hypovolemia, sepsis, etc.), but in many situations they are not easy to perform and require extensive knowledge and experience. Assessing the hemodynamic status of a critically ill patient based on dynamic mechanical models may be a good option for more accurate assessment of complex patients. Such a model is, for example, the iCVS model: it is a relatively simple, mechanical-dynamic model that can be used to understand complex cardiovascular conditions. This model requires only age and weight as initial data, and as dynamic data the model requires only an arterial blood pressure (AR) curve and a central venous pressure (CVP) curve. The model is based on the shape of the above curves for the purpose of analyzing the cardiovascular status of the patient. The model is suitable for both adults and children, although most of the work to date has been among pediatric intensive care patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The relevant experiment population are all patients over age 18 admitted to the ICU in Meir -

Exclusion criteria

Missing data

-

Treatment and study plan

Primary outcomes

  1. Optimization and validation of the ICVS model

    Time frame: 1 year

    The goal of this experiment is to perform an initial optimization and validation of the ICVS model with respect to the following metrics:

    • detection time before blood pressure drop
    • clinical shock classification.

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Validation of the iCVS Model in Patients Admitted to the Intensive Care Unit: a Retrospective Study

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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