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

NCT ID: NCT07256886

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-04-01

Study Completion Date

2030-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Shock

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with shock

Patients diagnosed with shock during ICU stay

No interventions assigned to this group

Patients without shock

Patients who were not diagnosed with shock during ICU stay

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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sara dichtwald

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MMC-0289-25

Identifier Type: -

Identifier Source: org_study_id

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