RecruitingPhase 2NCT06634069

Study SOLACE SEPSIS

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


Sponsor

University Hospital Pilsen

Enrollment

40 participants

Start Date

Nov 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study, called SOLACE SEPSIS, is testing a specific fluid resuscitation approach for people in septic shock — a life-threatening condition where the body's response to infection causes organ failure. The study focuses on whether carefully guided fluid management using ultrasound monitoring can improve outcomes for critically ill patients. **You may be eligible if...** - You are between 18 and 90 years old - You are in septic shock (your body is severely infected and you need blood pressure support with medication, and your blood lactate is elevated) - You need fluid treatment and show signs of poor circulation (such as delayed capillary refill, low urine output, or poor mental alertness) - Testing shows your heart is likely to respond well to fluids **You may NOT be eligible if...** - Your heart cannot be visualized by chest ultrasound - You weigh more than 160 kg - Your blood sodium is dangerously high - You have cardiac tamponade (fluid around the heart), severe valve disease, or life-threatening arrhythmia - You are expected to die before the study protocol can be completed - You need emergency dialysis within 2 hours - You have severe liver failure or active pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium Lactate

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

DRUG3% NaCl

active compartor 3% NaCl


Locations(1)

University Hospital Pilsen

Pilsen, Czech Republic, Czechia

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NCT06634069


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