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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Procedure: EaDyn Weaning Arm:; Procedure: PAM Weaning Arm:

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 Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia
    • Jorge Iván Alvarad
    • Contact: Jorge Alvarado; Email: jialvarados@unal.edu.co
    • Contact: Phone Number: 3017858459

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EaDyn weaning arm; 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	Procedure: EaDyn Weaning Arm: The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP >75 mmHg, a cardiac index (CI) >2.5 L/min/m², and a lactate level <2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the experimental group, vasopressor weaning is guided by the EaDyn value. Weaning can proceed as long as the EaDyn remains at or above 0.90. However, if the value drops below 0.90, the weaning process halts, and the norepinephrine dose is reverted to the last dose where the EaDyn value was ≥ 0.90. Regardless of the EaDyn value, any patient experiencing a MAP decline below 50 mmHg will be withdrawn from the study. Should the MAP range between 50 mmHg and 69 mmHg, a fluid challenge of 250 mL of isotonic crystalloid must be administered before weaning continues.
Active Comparator: PAM weaning arm; 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.	Procedure: PAM Weaning Arm: The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP >75 mmHg, a cardiac index (CI) >2.5 L/min/m², and a lactate level <2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the control group, vasopressor weaning progresses as long as the MAP remains at or above 70 mmHg. If the MAP falls between 50 and 69 mmHg, preload dependency is reassessed. Upon confirmation, a new fluid challenge is administered; vasopressor weaning halts, and the vasopressor dose reverts to its prior value. The weaning process can continue as long as the patient's MAP remains above 50 mmHg. If the MAP drops below this threshold, the patient exits the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of vasopressor support	Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation.	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundación Santa Fe de Bogota

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Dynamic arterial elastance (EaDyn).; vasopressor weaning.; septic shock.
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Shock, Septic
• Other Study ID Numbers: SECEC-2023-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No