Study SOLACE SEPSIS

Recruiting now · Phase 2

Conditions studied: Septic Shock, Intracranial Hypertension

In brief

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

Key facts

Study ID

NCT06634069

Run by

University Hospital Pilsen

People needed

40

Starts

2024-11-24

Expected to finish

2027-10-31

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subjects will not be eligible for the trial if they meet any of the following criteria:
• Poor transthoracic echo windows
• Actual body weight > 160 kg
• Hypernatremia: [Na] > 150 mEq/L
• Cardiac tamponade
• Uncorrected severe valvular heart disease or life-threatening arrhythmia
• Moribund patients likely to die before the study protocol is completed
• Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH < 7.0, K > 7.0mmol/L
• Severe liver dysfunction defined by total serum bilirubin > 120 umol/l
• Pregnancy and lactation

Where it is running

• University Hospital Pilsen — Pilsen, Czech Republic, Czechia (enrolling)

Full record on ClinicalTrials.gov

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