Investigating fluids for treating septic shock and intracranial hypertension

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

This study tests if two different fluids can help people with septic shock and high pressure in the brain feel better and improve their condition.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University Hospital Pilsen (other)
• Locations: 1 site (Pilsen, Czech Republic)
• Trial ID: NCT06634069 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the effects of two resuscitation fluids, 0.5M Sodium Lactate and 3% Saline, on hemodynamic and acid-base balance in patients experiencing septic shock and intracranial hypertension. It employs a randomized, double-blinded, controlled design to ensure unbiased results. Participants will be closely monitored for changes in their condition following the administration of these fluids. The study aims to provide insights into the efficacy of these off-label treatments in critical care settings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 who meet the criteria for septic shock and require fluid resuscitation.

Not a fit: Patients who do not meet the septic shock criteria or are outside the age range of 18 to 90 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients suffering from septic shock and intracranial hypertension.

How similar studies have performed: While the use of these fluids is off-label, similar studies have shown promise in treating septic shock, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Pilsen, Czech Republic

• University Hospital Pilsen — Pilsen, Czech Republic, Czechia (RECRUITING)

Study contacts

• Study coordinator: Miroslav Kříž, MD

Conditions: Septic Shock, Intracranial Hypertension, intracranial hypertension, septic shock