Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study
Recruiting now · Not applicable
Conditions studied: Critical Illness, Fluid Over-load, Dynamic Arterial Elastance, Septic Shock
In brief
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.
Key facts
- Study ID
- NCT06937918
- Run by
- Mahidol University
- People needed
- 60
- Starts
- 2025-04-23
- Expected to finish
- 2028-04-08
- Last updated by the study team
- 2025-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Siriraj Hospital, Mahidol University — Bangkok, Thailand (enrolling)
- Siriraj Hospital, Mahidol University — Bangkok, Thailand (enrolling)
- Faculty of Medicine Siriraj Hospital — Bangkok Noi, Bangkok, Thailand
Full record on ClinicalTrials.gov
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