French Observatory on the Management of Cardiogenic Shock 2
ConditionCardiogenic Shock
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorFrench Cardiology Society
About this trial
The aim of this observational study is to describe the baseline characteristics, management strategies, and early outcomes (during hospitalisation and at 30 days) of patients admitted to intensive care with cardiogenic shock, regardless of aetiology.
This prospective multicenter registry will enroll consecutive patients admitted to participating adult and pediatric critical care units in France, using current definitions and classifications of cardiogenic shock. The study aims to improve patient characterization and risk stratification and support the development of future interventional studies. 1,000 patients will be enrolled over 12 months, with follow-up at 30 days, 1 year, and through linkage with the French National Health Data System (SNDS) at 1 and 5 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients covered by a national health insurance scheme.
Patients who have provided explicit consent for the use of their National Health Identifier (NIR) for research purposes. If obtaining consent is temporarily impossible due to the patient's clinical condition, the emergency consent procedure described in the protocol will be applied.
Clinical: systolic blood pressure (SBP) < 90 mmHg and/or requirement for inotropic or vasopressor support to maintain SBP > 90 mmHg
Echocardiography: cardiac index (CI) < 2.2 L/min/m²
Disqualifiers
Final diagnosis other than cardiogenic shock.
Unwitnessed and/or prolonged cardiac arrest (estimated low-flow duration > 30 minutes) and/or absence of return of spontaneous circulation at the time of hospital admission.
Post-cardiotomy cardiogenic shock.
Individuals deprived of liberty by judicial or administrative decision.
Trial population
Adult or pediatric patients presenting with cardiogenic shock
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Patients hospitalized with cardiogenic shock
Trial outcomes
Primary outcomes
1
All-cause mortality during hospitalization and at 30 days
All-cause mortality assessed during the index hospitalization and at 30-day follow-up among patients hospitalized with cardiogenic shock of any etiology, excluding post-cardiotomy cardiogenic shock.
Time frame
30 daysSecondary outcomes
1
Use of in-hospital organ support therapies
Number and percentage of patients who received renal replacement therapy (dialysis), invasive or non-invasive mechanical ventilation, or acute circulatory support (ECMO, Impella, IABP, or other mechanical circulatory support devices) during the index hospitalization.
Time frame
Baseline2
Cognitive impairment assessed by the Codex test
Time frame
Within 24 hours prior to hospital discharge3
Use of long-term treatment for chronic heart failure among hospital discharge survivors
Time frame
Within 24 hours prior to hospital discharge, 1 year, and 5 years4
albumin-to-creatinine ratio
Time frame
on admission, Within 24 hours prior to hospital discharge, and at 1 yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: