Investigating fluids for treating septic shock and intracranial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Pilsen
  Pilsen, Czech Republic, Czechia Recruiting

Study contacts

• Study coordinator: Miroslav Kříž, MD
• Email: krizm@fnplzen.cz
• Phone: +420732850912

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.