Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT06937918
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06937918
Study Brief:
Protocol Section:
NCT06937918