Study SOLACE SEPSIS (MJIP1_0)

University Hospital Pilsen

Status and phase: Enrolling; Phase 2

Conditions: Intracranial Hypertension; Septic Shock

Treatments: Drug: 3% NaCl; Drug: Sodium Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT06634069

EU CTR: 2024-517927-37-00

Details and patient eligibility

About

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

Full description

This study investigates two resuscitation fluids that are being used off label for the treatment of patients suffering from septic shock and also in patients with intracranial hypertension in intensive care.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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: 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Group 1

Experimental group

Description:

Patients suffering from septic shock who require fluid resuscitation get 0.5M HSL (containing 504mM of sodium and lactate)

Treatment:

Drug: Sodium Lactate

Group 2

Active Comparator group

Description:

Patients suffering from septic shock who require fluid resuscitation get 3% NaCl (containing 513mM of sodium and chloride)

Treatment:

Drug: 3% NaCl