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RECRUITING
NCT06937918
NA

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

Sponsor: Mahidol University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-04-23

Completion Date

2028-04-08

Last Updated

2025-04-27

Healthy Volunteers

No

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

Locations (3)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Siriraj Hospital, Mahidol University

Bangkok, Thailand

Siriraj Hospital, Mahidol University

Bangkok, Thailand