Actively Recruiting
Phase 2 Study Comparing Effects of 0.5M Sodium Lactate and 3% Saline in Adults With Septic Shock
Led by University Hospital Pilsen · Updated on 2026-04-14
40
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
M
Miroslav Kříž, MD
M
Marek Nalos, MD
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