Evaluating Dynamic Arterial Elastance in Septic Shock Patients. (EaDyn)

Fundación Santa Fe de Bogota

Status: Not yet enrolling

Conditions: Septic Shock

Treatments: Procedure: EaDyn Weaning Arm:; Procedure: PAM Weaning Arm:

Study type: Interventional

Funder types: Other

Identifiers

NCT06118775

SECEC-2023-123

Details and patient eligibility

About

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

Full description

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

EaDyn weaning arm

Experimental group

Description:

In the EaDyn weaning arm of the study, dynamic arterial elastance (EaDyn) will be utilized as a specialized hemodynamic tool to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. EaDyn, a measure of the relationship between arterial pressure and stroke volume variation over the cardiac cycle, provides valuable insights into vascular tone and cardiac performance

Treatment:

Procedure: EaDyn Weaning Arm:

PAM weaning arm

Active Comparator group

Description:

In the PAM (Mean Arterial Pressure) weaning arm of the study, mean arterial pressure (MAP) will be used as the primary parameter to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. Mean arterial pressure represents the average pressure in the arteries during one cardiac cycle and is a crucial indicator of perfusion to vital organs. Participants in this group will be monitored continuously for their MAP values, allowing real-time assessment of their hemodynamic status.

Treatment:

Procedure: PAM Weaning Arm: