Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Adjustment of Vasopressor and Fluid Therapy in Septic Shock Resuscitation; A Pilot Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Siriraj Hospital, Mahidol University
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital
NOT_YET_RECRUITING
Bangkok Noi
Contact Information
Primary
Ranistha Ratanarat, MD
ranittha@gmail.com
+66 2419 7767
Backup
Nuwara Pornawalai, MD
nuwara.por@gmail.com
+66 2419 7767
Time Frame
Start Date: 2025-04-23
Estimated Completion Date: 2028-04-08
Participants
Target number of participants: 60
Treatments
Active_comparator: the standard of care group
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.
Experimental: AFM and Eadyn - guided resuscitation group
Patients randomized to this arm are treated with the standard of care for patients with septic shock as described for 'the standard of care' arm, along with the AFM and Eadyn - guided resuscitation group, as detailed under 'Interventions'
Related Therapeutic Areas
Sponsors
Leads: Mahidol University

This content was sourced from clinicaltrials.gov