Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

Septic Shock Clinical Trial

— EaDyn  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118775
• Other study ID #: SECEC-2023-123
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Fundación Santa Fe de Bogota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Exclusion Criteria:

• Pregnant individuals.
• Hemodynamic instability due to cardiac arrhythmias.
• Requiring two or more vasopressors.
• Requiring inotropic drug administration.
• 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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Procedure:
• EaDyn Weaning Arm:
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:
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.

Locations

Country	Name	City	State
Colombia	Jorge Iván Alvarad	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota

Country where clinical trial is conducted

Colombia, 

Outcome

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