Actively Recruiting
Study SOLACE SEPSIS
Led by University Hospital Pilsen · Updated on 2026-04-14
40
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study SOLACE SEPSIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Diagnosed with septic shock meeting all Sepsis 3 criteria: acute change in total SOFA score ≥ 2 due to infection, use of vasopressor to maintain mean arterial pressure ≥ 65 mmHg, blood lactate ≥ 2 mmol/L within last 24 hours
- Likely need for fluid resuscitation evidenced by poor peripheral perfusion (at least 2 of: peripheral cyanosis with capillary refill ≥ 3 seconds, low urinary output < 0.5 ml/kg/hour for ≥ 6 hours, central venous O2 saturation < 70%, clouded sensorium/poor mentation)
- Dynamic assessment showing preload responsiveness with at least one of: positive passive leg raising test, pulse pressure variation and/or stroke volume variation > 12%, distensibility index of inferior vena cava diameter > 12%
- Signed informed consent form
You will not qualify if you...
- Poor transthoracic echo windows
- Actual body weight over 160 kg
- Hypernatremia with sodium > 150 mEq/L
- Cardiac tamponade
- Uncorrected severe valvular heart disease or life-threatening arrhythmia
- Moribund patients likely to die before completing the study protocol
- Need for immediate acute hemodialysis/hemofiltration within 2 hours due to pH < 7.0 or potassium > 7.0 mmol/L
- Severe liver dysfunction with total serum bilirubin > 120 umol/l
- Pregnancy and lactation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Pilsen
Pilsen, Czech Republic, Czechia, 30100
Actively Recruiting
Research Team
M
Miroslav Kříž, MD
CONTACT
M
Marek Nalos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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