A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients
A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients
• Subjects will be eligible for the trial if they meet all of the following criteria:
‣ Age criteria: 18 - 90 years
⁃ Septic shock - Sepsis 3 criteria :
• acute change in total SOFA score ≥ 2 due to infection
∙ use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg
∙ blood lactate level ≥ 2 mmol/L within last 24 hours
⁃ Likely need for fluid resuscitation
• 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
∙ 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%
⁃ Signed the relevant informed consent form