SODIUM LACTATE for Septic shock

Inclusion criteria

• {"criterion_text":"- Subjects will be eligible for the trial if they meet all of the following criteria: 1. Age criteria: 18 – 90 years 2. Septic shock - Sepsis 3 criteria : a) acute change in total SOFA score ≥ 2 due to infection b) use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg c) blood lactate level ≥ 2 mmol/L within last 24 hours 3. Likely need for fluid resuscitation a) poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (< 0.5 ml/kg/hour for at least 6 hours) iii. central venous O2 saturation < 70% iv. clouded sensorium/poor mentation b) dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and / or stroke volume variation2, both > 12% iii. distensibility index of inferior vena caval diameter > 12% 4. Signed the relevant informed consent form (more in Chapter 10.1)"}

Exclusion criteria

• {"criterion_text":"- Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Poor transthoracic echo windows 2. Actual body weight > 160 kg 3. Hypernatremia: [Na] > 150 mEq/L 4. Cardiac tamponade 5. Uncorrected severe valvular heart disease or life-threatening arrhythmia 6. Moribund patients likely to die before the study protocol is completed 7. Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH < 7.0, K > 7.0mmol/L 8. Severe liver dysfunction defined by total serum bilirubin > 120 umol/l 9. Pregnancy and lactation"}

Primary endpoints

• {"endpoint_text":"- Change in cardiac stroke work (SW = SV x MAP) assessed by means of transthoracic echocardiography (SV) and a fluid filled arterial pressure transducer system (MAP) measured at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus (0.5M HSL or 3% NaCl). Monitored parameters:  SV (mL; start of infusion, 30 min and 60 min after start of infusion)  MAP (mmHg; start of infusion, 30 min and 60 min after start of infusion)","definition_or_measurement_approach":"Change in cardiac stroke work (SW = SV x MAP) measured by transthoracic echocardiography for stroke volume (SV) and a fluid-filled arterial pressure transducer system for mean arterial pressure (MAP) at start of infusion, at 30 minutes and at 60 minutes after start of infusion. Monitored parameters specified: SV (mL) and MAP (mmHg) at the stated timepoints."}

Secondary endpoints

• {"endpoint_text":"- Comparison of laboratory values of arterial blood gases and electrolytes between study groups","definition_or_measurement_approach":"Laboratory comparison of arterial blood gas values and serum/plasma electrolytes between the two study arms (0.5M HSL vs 3% NaCl)."}

Czechia

Earliest CTIS Part Ii Submission Date

25-09-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

47

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Fakultni Nemocnice Plzen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia