Status:
NOT_YET_RECRUITING
Evaluating Dynamic Arterial Elastance in Septic Shock Patients.
Lead Sponsor:
Fundación Santa Fe de Bogota
Conditions:
Septic Shock
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
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
Detailed 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 ca...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06118775
Start Date
March 1 2025
End Date
July 1 2026
Last Update
February 24 2025
Active Locations (1)
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1
Jorge Iván Alvarad
Bogotá, Colombia