Fact CheckerSign in

NCT06634069RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 14 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
7 Oct 2024
Start date
24 Nov 2024
Primary completion date
31 Oct 2027
Lead sponsor
University Hospital Pilsen
NCT number
NCT06634069

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 24 Nov 2024 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Pilsen
Coordinator of this site? Confirm its status
PilsenCzechiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.