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

NCT07256886 | Not Yet Recruiting

• 1 other identifier: MMC-0289-25
• Study Type: observational
• Target: 1,150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Shock

Keywords

shock

Outcome Measures

Primary Outcomes (1)

• Optimization and validation of the ICVS model

  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.

  1 year

Study Arms (2)

Patients with shock

Patients diagnosed with shock during ICU stay

Patients without shock

Patients who were not diagnosed with shock during ICU stay

Eligibility Criteria

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

Study Population

The relevant experiment population are all patients over age 18 admitted to the ICU in Meir. Research group: patients diagnosed with shock. Control group: patients not diagnosed with shock.

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: December 1, 2025

Record last verified: 2025-11