Clinical trial NCT06634069: Study SOLACE SEPSIS
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Septic Shock
Intracranial Hypertension
Keywords: intracranial hypertension
septic shock
Lead sponsor: University Hospital Pilsen
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

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

Primary outcomes:
measure: haemodynamic effects
timeFrame: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus
Secondary outcomes:
measure: acid-base effect
timeFrame: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus
measure: anti-inflammatory effect
timeFrame: parameters measured within the last 24 hours prior to start of infusion and within 24 hours after the study fluid infusion.
measure: Safety - Incidence of adverse events and reactions
timeFrame: 30 days after intervention
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: University Hospital Pilsen
state: Czech republic
Study officials:
References: