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
- Diseases
- High blood pressure
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Pilsen Coordinator of this site? Confirm its status | Pilsen | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.