Actively Recruiting
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
Led by University Hospital Pilsen · Updated on 2026-04-14
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different resuscitation fluids in patients suffering from septic shock and intracranial hypertension in intensive care. This pilot study is randomized, double-blinded, and controlled, focusing on how these fluids impact hemodynamics and acid-base balance. The trial is sponsored by University Hospital Pilsen and aims to understand the differences between the fluids in critical care settings. Participants will receive one of two treatments: 0.5M sodium lactate (containing 504mM of sodium and lactate) or 3% saline (containing 513mM of sodium and chloride). Both fluids are given as bolus infusions to patients requiring fluid resuscitation during septic shock. The study measures effects at the start, 30 minutes, and 60 minutes after infusion. It also includes monitoring for anti-inflammatory effects and safety outcomes over 30 days. During the study, participants will be closely monitored for hemodynamic changes and acid-base balance at specific timepoints. Anti-inflammatory markers will be assessed before and after the infusion, and adverse events will be tracked for a month. This involves clinical assessments, laboratory tests, and safety checks to evaluate the impact of the fluids. The total duration includes immediate post-infusion monitoring and a safety follow-up period.
CONDITIONS
Brief 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 Sepsis 3 criteria
- Acute change in total SOFA score ≥ 2 due to infection
- Use of vasopressor drug to maintain mean arterial pressure ≥ 65 mmHg
- Blood lactate level ≥ 2 mmol/L within last 24 hours
- Likely need for fluid resuscitation indicated by poor peripheral perfusion with at least 2 of 4 signs
- Dynamic assessment showing preload responsiveness by specific clinical tests
- Signed informed consent form
You will not qualify if you...
- Poor transthoracic echo windows
- Body weight over 160 kg
- Hypernatremia with sodium levels above 150 mEq/L
- Presence of cardiac tamponade
- Uncorrected severe valvular heart disease or life-threatening arrhythmia
- Moribund patients likely to die before study completion
- Immediate need for acute hemodialysis/hemofiltration within 2 hours
- Severe liver dysfunction with total serum bilirubin over 120 umol/l
- Pregnancy or lactation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 hour from the start of the fluid infusion
Participants receive either 0.5M Sodium Lactate or 3% NaCl fluid resuscitation for septic shock.
1 treatment visit (in intensive care) with assessments at start, 30 minutes, and 60 minutes from infusion start
Duration - 30 days after intervention
Participants are monitored for safety and adverse events following treatment.
Visits or contacts within 30 days post treatment to monitor adverse events
Trial Site Locations
Total: 1 location
1
University Hospital Pilsen
Pilsen, Czech Republic, Czechia, 30100
Actively Recruiting
Research Team
M
Miroslav Kříž, MD
M
Marek Nalos, MD
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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