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Recruiting Phase 2 NCT06634069

Study SOLACE SEPSIS

Trial Parameters

Condition Septic Shock
Sponsor University Hospital Pilsen
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2024-11-24
Completion 2027-10
Interventions
Sodium Lactate3% NaCl

Brief 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 Criteria

Inclusion Criteria: * Subjects will be eligible for the trial if they meet all of the following criteria: 1. Age criteria: 18 - 90 years 2. Septic shock - Sepsis 3 criteria : 1. acute change in total SOFA score ≥ 2 due to infection 2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg 3. blood lactate level ≥ 2 mmol/L within last 24 hours 3. Likely need for fluid resuscitation 1. 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 2. 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% 4. Signed the relevant informed consent form Exclusion Criteria: * Subjects w

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