Using advanced monitoring to improve fluid management in septic shock patients
Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Adjustment of Vasopressor and Fluid Therapy in Septic Shock Resuscitation; A Pilot Study
This study is testing a new monitoring device to see if it can help doctors manage fluids better for patients in septic shock and help them recover faster than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 3 sites (Bangkok Noi, Bangkok and 2 other locations) |
| Trial ID | NCT06937918 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a new hemodynamic monitoring device, Hemosphere(R), which utilizes dynamic arterial elastance and stroke volume change prediction to guide fluid and vasopressor therapy in patients with septic shock. The goal is to compare this advanced approach with standard care in mechanically ventilated patients to determine if it can reduce the time to shock reversal. The study focuses on patients experiencing hypotension due to septic shock, a condition characterized by systemic inflammation and vascular leakage. By employing artificial intelligence and arterial pressure waveform analysis, the study aims to enhance resuscitation strategies and minimize complications associated with fluid overload and vasopressor overuse.
Who should consider this trial
Good fit: Ideal candidates include Thai patients over 18 years old diagnosed with sepsis or septic shock who are receiving mechanical ventilation and invasive arterial pressure monitoring.
Not a fit: Patients with active life-threatening cardiac arrhythmias, acute coronary syndrome, or severe fluid intolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery from septic shock and reduced mortality rates in critically ill patients.
How similar studies have performed: While the use of advanced hemodynamic monitoring is gaining traction, this specific approach utilizing the Hemosphere(R) device is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok Noi, Bangkok and 2 other locations
- Faculty of Medicine Siriraj Hospital — Bangkok Noi, Bangkok, Thailand (Not_yet_recruiting)
- Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
- Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Ranistha Ratanarat, MD
- Email: ranittha@gmail.com
- Phone: +66 2419 7767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.