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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 23, 2025

Primary Completion Date

April 8, 2027

Study Completion Date

April 8, 2028

Conditions
Critical IllnessFluid Over-loadDynamic Arterial ElastanceSeptic Shock
Interventions
DEVICE

The AFM and Eadyn - guided resuscitation group

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

OTHER

The standard care for septic shock

"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"

Trial Locations (3)

10700

NOT_YET_RECRUITING

Faculty of Medicine Siriraj Hospital, Bangkok Noi

RECRUITING

Siriraj Hospital, Mahidol University, Bangkok

RECRUITING

Siriraj Hospital, Mahidol University, Bangkok

All Listed Sponsors
lead

Mahidol University

OTHER