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Recruiting Phase 2

Study SOLACE SEPSIS

NCT06634069 · tracked via the Priya Life Science Czechia tracker
Phase
Phase 2
Started
2024-11-24
Last updated
2026-04-14

Condition(s) studied

Septic ShockIntracranial Hypertension

Investigational drug(s) / intervention(s)

Sodium Lactate →3% NaCl →

Sodium Lactate: 0.5M HSL (containing 504mM of sodium and lactate)

3% NaCl: active compartor 3% NaCl

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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 outcome measure(s)

  • haemodynamic effects — at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus
    SV is the amount of blood that leaves the left ventricle with every beat cycle and is calculated by measuring the Doppler flow in the aortic valve. Unit: ml

Trial sites (1)

FacilityCityRegionStatus
University Hospital Pilsen Pilsen Czech Republic Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06634069 on ClinicalTrials.gov ↗ ← All trials in Czechia