Using advanced monitoring to improve fluid management in septic shock patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Siriraj Hospital, Mahidol University
  Bangkok, Thailand Recruiting
• Siriraj Hospital, Mahidol University
  Bangkok, Thailand Recruiting
• Faculty of Medicine Siriraj Hospital
  Bangkok Noi, Bangkok, Thailand Not yet recruiting

Study contacts

• Study coordinator: Ranistha Ratanarat, MD
• Email: ranittha@gmail.com
• Phone: +66 2419 7767

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.