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

NCT07256886 — Not yet recruiting, 1150 participants, Meir Medical Center

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

RegistryNCT07256886
StatusNot yet recruiting
Study typeObservational
Enrollment1150 (Estimated)
SponsorMeir Medical Center (Other)
ConditionsShock
Datesstart 2028-04-01 (estimated), primary completion 2030-04-01 (estimated), completion 2030-04-30 (estimated), first posted 2025-12-01, last updated 2026-10-09

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-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Patients with shockPatients diagnosed with shock during ICU stay
Patients without shockPatients who were not diagnosed with shock during ICU stay

+Outcome measures

Primary outcomes

  • Optimization and validation of the ICVS model [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

Exclusion Criteria: Missing data

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