Clinical trial NCT06118775: Evaluating Dynamic Arterial Elastance in Septic Shock Patients.
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Septic Shock
Keywords: Dynamic arterial elastance (EaDyn).
vasopressor weaning.
septic shock.
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open-label, pragmatic, parallel-group, controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using EaDyn as a hemodynamic tool to guide vasopressor weaning can reduce the duration of vasopressor support. Patients meeting the inclusion criteria will be randomly assigned to one of the two groups using computer-generated random numbers in a 1:1 ratio. In the first group, termed 'EaDyn weaning arm' (EaDyn), dynamic arterial elastance will be used as a tool for vasopressor weaning. In the second group, named 'PAM weaning arm,' mean arterial pressure will be used as the tool for vasopressor weaning. Due to the study's methodological characteristics, blinding of participants and investigators regarding group assignment will not be possible. Lastly, the study will be conducted on an intention-to-treat basis.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Duration of vasopressor support
timeFrame: 30 days
Secondary outcomes:
measure: Cumulative vasopressor dosage.
timeFrame: 30 days
measure: Overall hospital length of stay in days
timeFrame: 90 days
measure: Overall ICU length of stay in days.
timeFrame: 90 days.
measure: Acute Kidney Injury (AKI).
timeFrame: 90 days.
measure: Mortality
timeFrame: 90 days.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Jorge Iván Alvarad
Study officials:
References: