ShockNCT07256886
Validation of the iCVS Model in Patients Admitted to the Intensive Care Unit
An observational study of Shock, run by Meir Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- How many people
- 1,150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2028to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Validation of the iCVS Model in Patients Admitted to the Intensive Care Unit: a Retrospective Study
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
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with shock | Patients diagnosed with shock during ICU stay | |
| Patients without shock | Patients who were not diagnosed with shock during ICU stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Apr 2028 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256886
- Sponsor's protocol ID
- MMC-0289-25
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the iCVS Model in Patients Admitted to the Intensive Care Unit: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07256886
- Acronym / sponsor ID
- MMC-0289-25
- Conditions
- Shock
- Keywords
- shock
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2028 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with shock | – | –Patients diagnosed with shock during ICU stay |
| Patients without shock | – | –Patients who were not diagnosed with shock during ICU stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization and validation of the ICVS model (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.