RecruitingPhase 2

Study SOLACE SEPSIS

Czechia40 participantsStarted 2024-11-24

Plain-language 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

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Age criteria: 18 - 90 years
✓. Septic shock - Sepsis 3 criteria :
✓. acute change in total SOFA score ≥ 2 due to infection
✓. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg
✓. blood lactate level ≥ 2 mmol/L within last 24 hours
✓. Likely need for fluid resuscitation
✓. 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
✓. 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%

Exclusion criteria

✕. Poor transthoracic echo windows
✕. Actual body weight \> 160 kg
✕. Hypernatremia: \[Na\] \> 150 mEq/L
✕. Cardiac tamponade
✕. Uncorrected severe valvular heart disease or life-threatening arrhythmia
✕. Moribund patients likely to die before the study protocol is completed
✕. Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH \< 7.0, K \> 7.0mmol/L
✕. Severe liver dysfunction defined by total serum bilirubin \> 120 umol/l

What they're measuring

haemodynamic effects

Timeframe: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus

Trial details

NCT IDNCT06634069

SponsorUniversity Hospital Pilsen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-31

Contact for this trial

Miroslav Kříž, MD

+420732850912 krizm@fnplzen.cz

View on ClinicalTrials.gov More Septic Shock trials