Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

ConditionSeptic Shock
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorFundación Santa Fe de Bogota

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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.

Disqualifiers

Pregnant individuals.

Hemodynamic instability due to cardiac arrhythmias.

Hepatic cirrhosis.

Kidney or liver transplant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EaDyn Weaning Arm:

    Procedure/Surgery

    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 Regardless of the EaDyn value, any patient experiencing a MAP decline below 50 mmHg will be withdrawn from the study.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/Surgery

    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.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: EaDyn weaning armExperimental treatment 1 intervention
Group B: PAM weaning armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of vasopressor support

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

Time frame
30 days

Secondary outcomes

1

Cumulative vasopressor dosage.

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

Time frame
30 days
2

Overall hospital length of stay in days

Length of stay in the hospital in days.

Time frame
90 days
3

Overall ICU length of stay in days.

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

Time frame
90 days.
4

Acute Kidney Injury (AKI).

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

Time frame
90 days.

Other outcomes

Sponsors and contacts

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