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Software-guided fluid and vasopressor dosing in septic shock patients on ventilators

Tests device-guided fluid and vasopressor dosing in adults with septic shock needing ventilators.

Plain-language title generated from the registry record
Registry title: Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study

Key facts

Where
Bangkok and Bangkok Noi, ThailandSee the 2 sites

Where in Thailand

  • Siriraj Hospital Mahidol UniversityBangkok, ThailandTaking people
  • Faculty of Medicine Siriraj HospitalBangkok Noi, ThailandNot yet recruiting

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Trial details

Who runs it
Mahidol University
Trial code
NCT06937918
Record updated
27 April 2025
Original description
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.Read full original descriptionShow less

Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Adjustment of Vasopressor and Fluid Therapy in Septic Shock Resuscitation; A Pilot Study

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.

Inclusion: 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: Requirement for immediate surgery within 2 hours of randomization; 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; Life-threatening gastrointestinal hemorrhage; Advanced-stage cancer with predicted survival of less than 6 months; Severe asthma exacerbation; Fluid intolerance: hypoxemia (P:F ratio < 150); Pregnancy; 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.

ClinicalTrials.gov NCT06937918