Recruiting
Study SOLACE SEPSIS
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
ClinicalTrials.gov IDNCT06634069
PhasePHASE2
Enrollment40
SponsorUniversity Hospital Pilsen
Age18 Years
SexALL
Conditions studied
Septic Shock, Intracranial Hypertension
About this study
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
Interventions
- Drug: Sodium Lactate — 0.5M HSL (containing 504mM of sodium and lactate)
- Drug: 3% NaCl — active compartor 3% NaCl
Primary outcomes
- haemodynamic effects (at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus)
Eligibility information
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
Study locations
- University Hospital Pilsen, Pilsen, Czech Republic 30100 Czechia
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.