NCT06937918Recruiting
Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study
Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Adjustment of Vasopressor and Fluid Therapy in Septic Shock Resuscitation; A Pilot Study
Source: ClinicalTrials.gov · Last updated 27 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Apr 2025
- Start date
- 23 Apr 2025
- Primary completion date
- 8 Apr 2027
- Lead sponsor
- Mahidol University
- Diseases
- Stroke
- NCT number
- NCT06937918
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 23 Apr 2025 to the primary completion date, 8 Apr 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement for immediate surgery within 2 hours of randomization
Other illness
- 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
- Life-threatening gastrointestinal hemorrhage
- Advanced-stage cancer with predicted survival of less than 6 months
Other
- Severe asthma exacerbation
- Fluid intolerance: hypoxemia (P:F ratio \< 150)
- Pregnancy
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Siriraj Hospital Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Faculty of Medicine Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok Noi | Thailand | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.