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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
The AFM and Eadyn - guided resuscitation group
DeviceA 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 interventionThe 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
a time-to-goal achievement for septic shock resuscitation
MAP ≥ 65 mmHg with vasopressors and optimized tissue perfusion
time to NE titrating
maximum dose of vasopressors
volume of fluid therapy during resuscitation
Other outcomes
adverse event
ischemic complication and arrhythmia
Sponsors and contacts
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