Overview

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

Eligibility

Inclusion Criteria:

• 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 :
     1. acute change in total SOFA score ≥ 2 due to infection
     2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg
     3. blood lactate level ≥ 2 mmol/L within last 24 hours
  3. Likely need for fluid resuscitation
     1. 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
     2. dynamic assessment of preload responsiveness as evidenced by 1 out of 3:
     3. 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

Exclusion Criteria:

• 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