Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

Not Applicable

Not yet recruiting

• Conditions: Septic Shock

• Registration Number: NCT06118775
• Lead Sponsor: Fundación Santa Fe de Bogota

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 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.

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Study Start: 2025-03-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of vasopressor support	30 days	Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation.

Secondary Outcome Measures

Name	Time	Method
Overall ICU length of stay in days.	90 days.	Length of stay in the intensive care unit (ICU) in days.
Cumulative vasopressor dosage.	30 days	Total dose of norepinephrine administered from the initiation of vasopressor support to its discontinuation.
Overall hospital length of stay in days	90 days	Length of stay in the hospital in days.
Acute Kidney Injury (AKI).	90 days.	Proportion of AKI assessed according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines.
Mortality	90 days.	The number or percentage of deaths among patients diagnosed with septic shock during their hospitalization period.

Trial Locations

Locations (1)

Jorge Iván Alvarad; 🇨🇴 Bogotá, Colombia