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Cardiogenic ShockFrailShockNCT06692855

Prognostic Value of the Rockwood Clinical Frailty Score in Cardiogenic Shock

An observational study of Cardiogenic Shock, run by University Hospital, Strasbourg, France at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cardiogenic shock (CS) is characterized by tissue hypoperfusion resulting from cardiac dysfunction, without hypovolemia, where the ventricular pump is unable to generate adequate blood flow to meet the metabolic needs of the organs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiogenic Shock
How many people
300 participants
Where
1 siteFrance
Study dates
1 Oct 2024to 30 Nov 2025
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
  • Adult, Older adult

Study population: Adult patient (≥18 years) with cardiogenic shock according to ESC 2021 definition

Who may be able to join

  • Adult patient (≥18 years)
  • Patient with cardiogenic shock according to ESC 2021 definition
  • Patient hospitalized from January 1, 2014 to September 1, 2024 in an Intensive Care Unit
  • Patients who do not object to the re-use of their data for the purposes of this research.
  • Criteria Exclusion:
  • Patient having expressed his opposition to the re-use of his data for scientific research purposes.
  • Subject under court protection.
  • Subject under guardianship or curatorship.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France

    Strasbourg, 67091

    Hamid MERDJI, MD, 33 3 69 55 11 23, hamid.merdji@chru-strasbourg.fr

    Hamid MERDJI, MD

    Recruiting

Other trials in France

About this study

Cardiogenic shock (CS) is characterized by tissue hypoperfusion resulting from cardiac dysfunction, without hypovolemia, where the ventricular pump is unable to generate adequate blood flow to meet the metabolic needs of the organs.

To date, the management of CS is a challenge for cardiologists and intensive care physicians, particularly with regard to the stratification of the severity of these patients to accurately determine the prognostic outcome. Thus, although specific prognostic scores for CS already exist, they are often inefficient and difficult to calculate quickly at the patient's bedside. For example, the CardShock risk score is a score composed of seven variables (including biological and echocardiographic parameters) allowing in the best case to obtain an area under the curve (AUC) for the prediction of mortality around 0.7. More recently, the SCAI Shock classification was developed to progressively stratify patients into five groups of increasing severity, ranging from A to E for the most serious. Although its prognostic interest is better than the CardShock, this recently updated classification is also based on biological or echocardiographic parameters that are sometimes difficult to collect in an emergency.

Read more

Thus, there is currently no simple and optimal prognostic score to predict the prognosis of patients and even less of a score that takes into account the overall clinical fragility of patients appropriately.

In this context, the Rockwood clinical fragility score, also called the "Clinical Frailty Scale" (CFS), has emerged in recent years as an iconographic score accompanied by an explanatory text initially developed to assess fragility in the elderly. It is a pure declarative score, very easy to perform in clinical practice, even in acute situations or in delirious or even sedated patients. It also has the advantage of being free since it only groups together the physiological and functional data characterizing the previous state of a subject before the diagnostic and therapeutic stage. The CFS makes it possible to estimate the degree of fragility of a patient ranging from "very fit" or robust, active, energetic to "terminal phase". It is based on information that is easily retrieved from the patient or the patient's relatives with the advantage of having a very good correlation with the fragility scores that are more complex to evaluate.

Finally, the CSF has already proven its worth in acute cardiology, such as in myocardial infarction where this score was independently and strongly associated with all-cause mortality at 6 months and where it was highlighted that fragile patients had a poorer outcome, a higher risk of mortality, risk of CS and risk of bleeding.

Optimal management of CS patients requires both a thorough, rapid, reliable and easy-to-obtain assessment in an emergency in order to initiate appropriate interventions as quickly as possible. In this perspective, the CFS emerges as a promising parameter in the initial assessment of these patients, particularly to identify patients with a higher risk of complications. This score alone or in addition to the scores already used in practice in the CS represents an innovative perspective and could allow a more detailed assessment of patients and thus help clinicians to better target the necessary interventions and to individualize the management. Indeed, optimizing the identification of patients with acute critical cardiology is one of the avenues suggested as an area for improvement by experts in this field at the border of cardiology and resuscitation. The simplicity of this tool, combined with its ability to assess the overall vulnerability of the patient, opens the way to increased personalization of care in CS patients.

Keywords
Cardiogenic shock, CardShock risk score, Area under the curve (AUC), SCAI Shock classification, Clinical Frailty Scale (CFS)
Medical subject headings
Shock, Cardiogenic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death at 28 days after cardiogenic shock

    Measured: 28 days after cardiogenic shock

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start1 Oct 2024
  3. Primary completionNov 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

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 only
Time perspective
Retrospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06692855
Sponsor's protocol ID
9454
Acronym
FrailShock
Status last verified
Nov 2024
First submitted
14 Nov 2024
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock, run by University Hospital, Strasbourg, France at 1 site in France.

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 8 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Hamid MERDJI, MD (33 3 69 55 11 23, hamid.merdji@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death at 28 days after cardiogenic shock (time frame: 28 days after cardiogenic shock). 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 18 Nov 2024.

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