Status:
RECRUITING
Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study
Lead Sponsor:
Mahidol University
Conditions:
Critical Illness
Fluid Over-load
Eligibility:
All Genders
18+ years
Phase:
NA
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 in...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 8 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06937918
Start Date
April 23 2025
End Date
April 8 2028
Last Update
April 27 2025
Active Locations (3)
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1
Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
2
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
3
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700