Sepsis-induced hypotension Septic shock Fluid overload Fluid responsive test Sepsis-induced hypotension Septic shock ultrasound-guided fluid responsive test
Conditions
Interventions
Patients randomized to the intervention group underwent point-of-care ultrasonography (POCUS) to assess fluid responsiveness by measuring the respiratory variation in the Left Ventricular Outflow Trac
Experimental Procedure/Surgery,No Intervention Procedure/Surgery
POCUS-Guided Group (LVOT VTI Respiratory Variation),Usual Care Group
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older 2. Presence of sepsis, as defined by the Sepsis-3 criteria: -Suspected or confirmed infection, along with an increase in SOFA score of >= 2points 3. Hemodynamic instability, defined as: -Mean arterial pressure (MAP) < 65 mmHg, or -Systolic blood pressure (SBP) < 90 mmHg, or -SBP decrease > 40 mmHg from baseline, or -Serum lactate level > 2 mmol/L, or -Urine output < 0.5 ml/kg/h. 4. Clinically indicated need for fluid administration due to hemodynamic instability 5. Patients diagnosed with septic shock within 24 hours and deemed eligible for enrollment following initial evaluation
Exclusion criteria
Exclusion criteria: 1. Pregnant women. 2. Patients with atrial fibrillation. 3. Patients with severe aortic regurgitation. 4. Patients with subaortic obstruction 5. Patients with cardiogenic pulmonary edema. 6. Patients with fluid overload or fluid intolerance, as evidenced by: -Pulmonary edema on chest X-ray, or -Oxygen saturation decreased by >= 5% from baseline, or -Others signs consistent with fluid intolerance or overload. 7. Patients with anatomical limitations that preclude adequate ultrasound imaging for measurement. 8. Patients with a DO NOT RESUSCITATION (DNR) order. 9. Patients or their legal representatives who refuse or decline to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to shock reversal Measured from randomization until achievement of stable MAP greater than or equal to 65 mmHg. Continuous hemodynamic monitoring, recorded from time of enrollment until shock reversal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total volume of intravenous fluid From enrollment to shock reversal Total fluid volume (mL),Cumulative vasopressor dose From enrollment to time of shock reversal Norepinephrine equivalent dose (mcg/kg/min),ICU Length of Stay From enrollment to ICU discharge Number of days,28-day Mortality Day 28 post-enrollment Survival status (alive/dead),Mechanical Ventilation-Free Days Within 28 days post-enrollment Number of days alive and free from invasive mechanical ventilation,Time to urine output greater than or equal to 0.5 mL/kg/hr From enrollment to first achievement of the target urine output Time duration (hours:minutes) to achieve sustained urine output greater than or equal to 0.5 mL/kg/hr,Complications associated with fluid administration: Acute Kidney Injury (AKI) From enrollment to time of shock reversal As defined by KDIGO criteria,Complications associated with fluid administration: Recurrent Shock During ICU stay after initial shock reversal Need for reinitiation of vasopressors after greater than or equal to 12 hours off,Complications associated with fluid administration: Pulmonary Edema From enrollment to time of shock reversal Clinical diagnosis via chest X-ray (e.g., pulmonary congestion, Kerley B lines) or lung ultrasound (greater than or equal to 3 B-lines or E/e' greater than 15) | — |
Countries
Thailand
Contacts
Public ContactChompoothip Siriworrarath
Siriraj Hospital
Outcome results
None listed