Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Septic Shock

Intervention / Treatment
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* Procedure: EaDyn Weaning Arm:
* Procedure: PAM Weaning Arm:


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged 18 years or older. Patients with septic shock as defined by the third international sepsis consensus, clinically presenting with the need for vasopressor support to maintain a Mean Arterial Pressure (MAP) ≥ 65 mmHg or a lactate level greater than 2 mmol/L in the absence of hypovolemia. SOFA (Sequential Organ Failure Assessment) score ≥ 9. Patients requiring vasopressor support for a duration equal to or longer than 4 hours. Exclusion Criteria: Pregnant women. Cardiac arrhythmias. Treatment with other vasopressors or inotropes. Right heart failure. Patients with hepatic cirrhosis. Patients who have undergone kidney and/or liver transplantation. Patients with a high probability of mortality within 24 hours according to medical judgment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EaDyn weaning arm<br>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:<br>* In the intervention group, where the EaDyn-guided weaning strategy is applied, the norepinephrine dosage will be systematically reduced every 15 minutes. Weaning will continue until the EaDyn value, measured through TPTD, reaches or exceeds 0.94, indicating improved hemodynamic stability. Weaning will cease if EaDyn falls below 0.94, ensuring patient safety. If the patient's Mean Arterial Pressure (MAP) is below 70 mmHg, yet the EaDyn value is 0.94 or higher, a 250 ml crystalloid infusion will be administered to maintain adequate perfusion. Additionally, for patients showing preload dependence, characterized by a more than 15% increase in Systolic Volume after Passive Leg Raising measured by TPTP, a fluid challenge with 250 ml of lactated Ringer's solution will be administered, optimizing preload and patient's hemodynamic status.<br>|
| Active Comparator: PAM weaning arm<br>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:<br>* A gradual reduction of norepinephrine dosage by 0.01 mcg/kg/min will be implemented every 15 minutes in both study groups. In the control group, this reduction will persist until Mean Arterial Pressure (MAP) remains above or equal to 70 mmHg. Weaning will pause if MAP drops below 70 mmHg. In such cases, the patient's preload status will be assessed using a Passive Leg Raising (PLR) test. If the patient exhibits preload dependence, defined as a more than 15% increase in systolic volume after PLR measured by TPTD, a fluid challenge with 250 ml of lactated Ringer's solution will be administered. For patients with adequate preload, no fluids will be given, and the norepinephrine dosage will be increased to the level used before the decrease in MAP occurred.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dynamic arterial elastance (EaDyn)., vasopressor weaning., septic shock.