Clinical trial NCT06937918: Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study
Official title: Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Adjustment of Vasopressor and Fluid Therapy in Septic Shock Resuscitation; A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Fluid Over-load
Dynamic Arterial Elastance
Septic Shock
Keywords: critical illness
dynamic arterial elastance
stroke volume change prediction
fluid overload
ischemic complication
septic shock
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 wait for the response of the machine for 5 minutes after loading. 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\[5\] along with a vasopressor will be administered and titrated every 10 minutes until the target mABP \> 65 mmHg is reached.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Hypotension in the context of an intensive care unit has been associated with a higher risk of death and multiorgan dysfunction. Vascular leakage and systemic vasodilatation are brought on by systemic inflammation from infections. These are the hallmarks of septic shock in which 90% of cases of shock are mostly distributive and hypovolemic. Early vasopressors and fluid therapy are increasingly used at the start of vasodilatory shock resuscitation since this method improves the rate of shock control within 6 hours in septic shock resuscitation. Norepinephrine is the first-line vasopressor for vasodilatory shock. However, resuscitation with an accurate amount of fluid and vasopressor is challenging in clinical practice. Fluid overload and overuse of vasopressors are prevalent and increase mortality. Together with a higher dose of norepinephrine, it may increase the risk of ischemic complications.

A new hemodynamic monitoring device (Hemosphere(R) - Edward Lifescience, California, USA) provides two novel parameters for hemodynamic monitoring: the new device with artificial intelligence developed by a retrospective cohort (used for training) and a prospective (local hospital cohort used for external validation). The feature of Hemosphere(R), including dynamic arterial elastance (Eadyn) and stroke volume change prediction (∆SVpredict) as the assist fluid management (AFM) based on arterial pressure waveform analysis by the monitoring software, was detected in arterial line waveform without any complication of a safety issue.

The ratio of pulse pressure to stroke volume (PP/SV) is defined by dynamic arterial elastance (Eadyn), the reciprocal of compliance within the range of 0.8 to 1.0 is the optimization of arterial load that can predict arterial pressure response to fluid administration and vasopressor weaning. The prediction of the stroke volume changes following the upcoming fluid therapy (∆SVpredict) uses stroke volume variation parameters and closed-loop feedback data, which should be less than 10% to indicate optimal fluid administration. Consequently, this technique offers a useful means of evaluating arterial tone related to preload responsiveness parameters predicting the hemodynamic response to increases in cardiac preload.

However, several studies show the benefit of this tool in perioperative patients, and the evidence on the benefit of using this monitoring to guide septic shock resuscitation is limited. In a previous study, Eadyn can predict a decrease in mean arterial pressure linked to a reduction in norepinephrine dosage. This study aimed to investigate the benefit of using AFM and Eadyn-guided fluid and vasopressor therapy in septic shock resuscitation compared with the standard of care

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Severe asthma exacerbation
* Fluid intolerance: hypoxemia (P:F ratio \< 150)
* Life-threatening gastrointestinal hemorrhage
* Pregnancy
* Requirement for immediate surgery within 2 hours of randomization
* Advanced-stage cancer with predicted survival of less than 6 months
* Oliguric AKI with signs of volume overload

Withdrawal or termination criteria

* The patient and legal representative request for withdrawal
* The attending physician requested a withdrawal

Primary outcomes:
measure: time to shock reversal
timeFrame: 28 days
Secondary outcomes:
measure: a time-to-goal achievement for septic shock resuscitation
timeFrame: 28 days
measure: time to NE titrating
timeFrame: 48 hours
measure: maximum dose of vasopressors
timeFrame: 48 hours
measure: volume of fluid therapy during resuscitation
timeFrame: 48 hours
measure: fluid before randomization
timeFrame: 48 hours
measure: fluid accumulation at 24 hours
timeFrame: 24 hours
measure: fluid accumulation at 72 hours
timeFrame: 72 hours
measure: fluid accumulation at 7 days
timeFrame: 7 days
measure: 28-day hospital mortality
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: hospital length of stay
timeFrame: 28 days
measure: shock reversal at 6 hours
timeFrame: 6 hours
measure: rate of new initiation of renal replacement therapy
timeFrame: 28 days
measure: time to initiation of renal replacement therapy
timeFrame: 28 days
measure: Vasopressor-free day
timeFrame: 28 days
measure: Ventilator-free day
timeFrame: 28 days
measure: Renal replacement therapy(RRT)-free day
timeFrame: 28 days
measure: Serum lactate at 0 hours, 1 hour, and 6 hours
timeFrame: 6 hours
Other outcomes:
measure: adverse event
timeFrame: 28 days
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
References:
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