BridgeMD
New treatment option for Septic Shock
Official title Study SOLACE SEPSIS
ClinicalTrials.gov ID: NCT06634069
What this study is testing
What is Sodium Lactate?
Sodium Lactate is an investigational medicine, being studied as a potential treatment for septic shock.
Also referred to as 0.5M natrii lactatis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- people 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
You likely can't join if
- people 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
See the full eligibility criteria
- people 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 \<...
- 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...
- Signed the relevant informed consent form
- people 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 \ 7.0mmol/L
- Severe liver dysfunction defined by total serum bilirubin \> 120 umol/l
- Pregnancy and lactation
The study team makes the final eligibility decision.
Where it's taking place
- Pilsen, Czech Republic, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pilsen, Czech Republic, Czechia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.