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Official title Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study
ClinicalTrials.gov ID: NCT06937918
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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 likely can't join 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)
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok Noi, Bangkok, Thailand
- Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok Noi, Bangkok, Thailand; Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.