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NCT Number: NCT06118775

Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

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

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EaDyn Weaning Arm:

Procedure

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.

PAM Weaning Arm:

Procedure

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.

Primary outcomes

  1. Duration of vasopressor support

    Time frame: 30 days

    Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation.

Secondary outcomes

  1. Cumulative vasopressor dosage.

    Time frame: 30 days

    Total dose of norepinephrine administered from the initiation of vasopressor support to its discontinuation.

  2. Overall hospital length of stay in days

    Time frame: 90 days

    Length of stay in the hospital in days.

  3. Overall ICU length of stay in days.

    Time frame: 90 days.

    Length of stay in the intensive care unit (ICU) in days.

  4. Acute Kidney Injury (AKI).

    Time frame: 90 days.

    Proportion of AKI assessed according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines.

  5. Mortality

    Time frame: 90 days.

    The number or percentage of deaths among patients diagnosed with septic shock during their hospitalization period.

Sponsors and collaborators

Lead sponsor

Fundación Santa Fe de Bogota

Other

Registry information

Official study title

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

Acronym: EaDyn

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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