Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

About this trial

To investigate the benefit of using the AFM and Eadyn-guided fluid and vasopressor therapy in septic shock resuscitation for mechanically ventilated patients compared with the standard of care. The investigators hypothesize that using the AFM and Eadyn-guided fluid/vasopressor titration in septic shock patients who underwent mechanical ventilation might reduce the time to shock reversal.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All Thai consecutive patients older than 18 years with a diagnosis of sepsis or septic shock in medical ICU, defined by clinically suspected or confirmed infection and MAP <65 mmHg according to the criteria of the Surviving Sepsis Campaign 2021(11)with onset of shock in less than 24 hours.

Already receiving or planning for mechanical ventilation

Already receiving or planning for arterial catheter placement for invasive arterial pressure monitoring

All patients will receive an echocardiogram with a cut point of LVEF > 30% to be included in the study

Disqualifiers

Active, immediate, life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation

Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage

Acute coronary syndrome

cardiogenic shock, acute heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • The AFM and Eadyn - guided resuscitation group

    Device

    A fluid challenge using a stroke volume change prediction (∆SVpredict) and Eadyn guide. If the ∆SVpredict is more than 10%, isotonic crystalloid of 500 ml will be administered in 30 minutes, and the machine's response will be awaited. If ∆SVpredict is still more than 10%, continuous fluid loading was reapplied until SVV was less than 10% (fluid therapy will be stopped if ∆SVpredict is less than 10%) and dynamic arterial elastance (EAdyn) reaches the goal of 0.8-1.0 along with a vasopressor will be administered and titrated every 10 minutes until the target MAP \> 65 mmHg is reached. After MAP of 65 achieved, tissue perfusion including urine output, capillary refill time, and serum lactate will be assessed

  • The standard care for septic shock

    Other intervention

    The standard of care group will be treated according to according to septic shock guidelines 2021; In brief A vasopressor with optimal ideal fluid (at least 30 ml/kg) will be given to achieve the hemodynamic target (MAP ≥ 65 mm Hg) by fluid challenge technique guided by MAP and central venous pressure (CVP) changes after fluid challenge. Fluid-responsive tests can be used as a subsidiary, depending on the attending physician. Early Norepinephrine (NE) infusion can be used with a standard dose of 0.05 mcg/k/min and titrated at the rate of 0.01-0.02 mcg/kg/min every 10 min until 0.25 mcg/kg/min was achieved; then, the second line vasopressor will be added and adjusted to the target of vasopressor. Hydrocortisone can be given according to septic shock guidelines. After MAP of 65 achieved, tissue perfusion including urine output, capillary refill time, and serum lactate will be assessed

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: the standard of care groupActive comparator 1 intervention
Group B: AFM and Eadyn - guided resuscitation groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

time to shock reversal

the time from diagnosis of septic shock until the achievement of sustained MAP of ≥65 mmHg with evidence of adequate tissue perfusion (continuation of urine flow ≥ 0.5 ml/kg/h or normalized or continuing decrease in serum lactate ≥10% from the previous value) without any vasopressor infusion

Time frame
28 days

Secondary outcomes

1

a time-to-goal achievement for septic shock resuscitation

MAP ≥ 65 mmHg with vasopressors and optimized tissue perfusion

Time frame
28 days
2

time to NE titrating

Time frame
48 hours
3

maximum dose of vasopressors

Time frame
48 hours
4

volume of fluid therapy during resuscitation

Time frame
48 hours

Other outcomes

1

adverse event

ischemic complication and arrhythmia

Time frame
28 days

Sponsors and contacts

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