Menu
Not yet recruiting NCT06118775

Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

No phase Interventional Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EaDyn Weaning Arm:, PAM Weaning Arm:.
Who it may be relevant to
Registry conditions: Septic Shock. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • 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, t
  • 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 conf

Primary outcome measures

  • Duration of vasopressor support [Time frame: 30 days]
Secondary outcome measures (5)
  • Cumulative vasopressor dosage. [Time frame: 30 days]
  • Overall hospital length of stay in days [Time frame: 90 days]
  • Overall ICU length of stay in days. [Time frame: 90 days.]
  • Acute Kidney Injury (AKI). [Time frame: 90 days.]
  • Mortality [Time frame: 90 days.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Colombia · 1 center
  • Jorge Iván Alvarad — Bogotá

Publications

  • Alvarado Sanchez JI, Montanez-Narino AV, Cardenas-Bolivar YR, Stozitzky-Rios MV, Mora-Salamanca AF. Efficacy and safety of dynamic arterial elastance for weaning vasopressor support in septic shock patients: a randomised controlled trial protocol. BMJ Open. 2024 Aug 7;14(8):e086388. doi: 10.1136/bmjopen-2024-086388. PMID 39117412

Identifiers

NCT: NCT06118775 · SECEC-2023-123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗