Despite advancements in treatment, the mortality rate for cardiogenic shock (CS) remains high at around 50%. The EMPULSE-HF trial showed that early introduction of empagliflozin in stabilized patients with acute heart failure led to a composite benefit in mortality, rehospitalization, and quality of life.
Growing evidence suggests that cardiogenic shock isn't just a problem of systemic macrocirculation (blood pressure, cardiac output). It also involves significant abnormalities in the systemic microcirculation. In fact, these microcirculatory parameters have proven to be better predictors of patient outcomes than traditional macrocirculatory measures.
Given its known vasculo-protective effects on the endothelium, empagliflozin may have a beneficial impact on the microcirculation, potentially explaining its positive effects in cardiogenic shock.
This study will explore this hypothesis by analyzing the microcirculation in real-time using the CytoCam-IDF imaging videomicroscope and its MicroTools software. The goal is to gain a deeper understanding of how empagliflozin affects the microcirculation during cardiogenic shock.
Patient included in the main EMPASHOCK study
Patient has signed a consent form for the ancillary study
Patient is over 18 years old
Hospitalized in the Intensive Care Unit for cardiogenic shock*
• GFR < 20 ml/min/1.73m²
Chronic dialysis
Patient on SGLT2 inhibitors prior to ICU admission
Known allergy to SGLT2 inhibitors or any of their excipients (in particular, patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome).
Parallel
microcirculation using the video microscopy tool.
Diagnostic testThe study intervention is the assessment of microcirculation using the video microscopy tool. This study's primary purpose is to perform this specific diagnostic procedure-measuring microcirculatory parameters with the CytoCam-IDF device-at two distinct time points: at inclusion (H0) and again 48 hours later (H48). The administration of empagliflozin (or not), which is pa and 48 hours after initiating empagliflozin treatment, microcirculatory data will be collected using a videomicroscope. A camera, roughly the size of a large pen, is placed under the patient's tongue for a few seconds to acquire images of the sublingual microcirculation. The entire image acquisition process takes less than 5 minutes and is unaffected by whether the patient is intubated. Images are then analyzed in real-time by the MicroTools software, which calculates key microcirculatory parameters. All anonymized images are stored on a dedicated, password-protected computer accessible only to the investigators.
The difference in the evolution of a parameter reflecting the microcirculation between the two groups at 48 hours post-randomization.
To estimate the effect of the early introduction of empagliflozin, in addition to usual care versus usual care alone, at 48 hours post-randomization, on sublingual microcirculation.(functional capillary density (FCD)) with the CytoCam-IDF imaging videomicroscope and its MicroTools software
Correlation between microcirculation parameters and macrocirculation parameters.
Cardiac power index
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Total vessel density (TVD)
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Proportion of perfused vessels (PPV)
The difference in the evolution of other microcirculation parameters between the two groups at 48 hours.
Functional capillary density (FCD),
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