Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study

Launched by MAHIDOL UNIVERSITY · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help patients with septic shock, a serious condition that occurs when an infection leads to low blood pressure and can be life-threatening. Researchers want to see if using special software to guide fluid and medication treatment can help patients recover more quickly compared to standard care. The study will involve patients who are on mechanical ventilation and need close monitoring of their blood pressure.

To be eligible for the trial, participants must be at least 18 years old and diagnosed with sepsis or septic shock, which means they have a severe infection and low blood pressure. They should also be receiving mechanical ventilation and have a certain level of heart function. However, individuals with certain serious heart conditions, recent strokes, or other specific health issues will not be included. If a patient joins the study, they can expect to receive either the new guided treatment or standard care and will be closely monitored throughout the process. It's important to note that participation is voluntary, and patients can withdraw from the study at any time if they choose.

Gender

ALL

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