NCT06937918 Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study
| NCT ID | NCT06937918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-23 |
| Primary Completion | 2027-04-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-23 with a primary completion date of 2027-04-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06937918 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06937918 currently recruiting?
Yes, NCT06937918 is actively recruiting participants. Contact the research team at ranittha@gmail.com for enrollment information.
Where is the NCT06937918 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand, Bangkok, Thailand, Bangkok, Thailand.
Who is sponsoring the NCT06937918 clinical trial?
NCT06937918 is sponsored by Mahidol University. The trial plans to enroll 60 participants.