Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

Assessment of the Effectiveness and Safety of Dynamic Arterial Elastance in Weaning Vasopressor Support in Patients with Septic Shock: a Randomized Controlled Clinical Trial At Santa Fé Foundation in Bogotá

Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group

An open-label, randomized controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using dynamic arterial elastance (EaDyn) as a tool to guide vasopressor weaning can reduce the duration of vasopressor support. Eligible patients will be randomly assigned to either the EaDyn weaning arm or the mean arterial pressure (MAP) weaning arm in a 1:1 ratio. Blinding of participants and investigators will not be possible due to the study's methodology. The analysis will be conducted on an intention-to-treat basis.

Inclusion Criteria:

• ≥ 18 years of age.
• Admission to the ICU.
• Septic shock defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
• Hypotension requiring vasopressor support to maintain a MAP ≥ 65 mmHg.
• SOFA score ≥ 4.
• Vasopressor support duration ≥ 4 hours.
• Patients requiring mechanical ventilation.
• Patients who have reached the hemodynamic stabilization phase and are ready to begin the vasopressor weaning process with norepinephrine, defined as: mean arterial pressure (MAP) > 75 mmHg, cardiac index (CI) > 2.5 L/min/m², and lactate level < 2 mmol/L.

Exclusion Criteria:

• Pregnant individuals.
• Hemodynamic instability due to cardiac arrhythmias.
• Hepatic cirrhosis.
• Kidney or liver transplant.
• High probability of mortality within 24 hours, according to medical judgment.
• Left ventricular ejection fraction (LVEF) less than 50%.
• Right ventricular dysfunction, defined as a TAPSE (Tricuspid Annular Plane Systolic Excursion) measurement of less than 1.6 cm.
• Patients spontaneously breathing.