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Septic ShockPhase 2MJIP1_0NCT06634069

Study SOLACE SEPSIS

A Phase 2 study testing Sodium Lactate and 3% NaCl in people with Septic Shock and Intracranial Hypertension, run by University Hospital Pilsen at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Septic Shock, Intracranial Hypertension
What is being tested?
Sodium Lactate and 3% NaCl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCzechia
Study dates
24 Nov 2024to 31 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Miroslav Kříž, MD contact

+420732850912

krizm@fnplzen.cz

Marek Nalos, MD contact

marek.nalos@gmail.com

Czechia1 site, 1 recruiting

  • University Hospital Pilsen

    Pilsen, Czech Republic, 30100

    Miroslav Kříž, MD, +420 732 850 912, krizm@fnplzen.cz

    Marek Nalos, mareknalos@gmail.com

    Recruiting

Other trials in Czechia

About this study

Official title: 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

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

Read the detailed description

This study investigates two resuscitation fluids that are being used off label for the treatment of patients suffering from septic shock and also in patients with intracranial hypertension in intensive care.

Being tested
Sodium Lactate, 3% NaCl
Keywords
intracranial hypertension, septic shock
Medical subject headings
Shock, Septic, Intracranial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium LactateDrug

    Also called 0.5M natrii lactatis

    0.5M HSL (containing 504mM of sodium and lactate)

  • 3% NaClDrug

    active compartor 3% NaCl

Study groups in NCT06634069
Study groupRoleWhat they receive
Group 1ExperimentalPatients suffering from septic shock who require fluid resuscitation get 0.5M HSL (containing 504mM of sodium and lactate)
Receives: Drug: Sodium Lactate
Group 2Active comparatorPatients suffering from septic shock who require fluid resuscitation get 3% NaCl (containing 513mM of sodium and chloride)
Receives: Drug: 3% NaCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. haemodynamic effects

    SV is the amount of blood that leaves the left ventricle with every beat cycle and is calculated by measuring the Doppler flow in the aortic valve.

    Unit: ml

    Measured: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus

Secondary outcomes (3)

  1. acid-base effect

    Diagnostic approach to acid-base changes is based on the assessment of bicarbonate buffer system, in which pH is determined by the ratio of [HCO3-] to pCO2 meassured by a POC whole-blood analyzer system

    Unit: [HCO3-] - mmol/l, pCO2 - kPa

    Measured: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus

  2. anti-inflammatory effect

    Inflammatory markers as CRP, procalcitonin, interleukin-6 and feritin are sepcific indicators linked to degree of inflammation and determined by regular biochemical analysis. The dynamics of parameters after the study fluid administration will be evaluated.

    Unit: CRP - mg/l, procalcitonin - ug/l, interleukin-6 - ng/l, ferritin - ug/l

    Measured: parameters measured within the last 24 hours prior to start of infusion and within 24 hours after the study fluid infusion.

  3. Safety - Incidence of adverse events and reactions

    Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) and descriptive analysis of the incidence of any adverse events and reactions during participation in the study in both study arms. AEs are defined according to the valid definitions for clinical trials as imposed by legislation (Directive 2001/20/EG).

    Measured: 30 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start24 Nov 2024
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06634069
Sponsor's protocol ID
EU CTR: 2024-517927-37-00
Acronym
MJIP1_0
Status last verified
Apr 2026
First submitted
7 Oct 2024
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Not yet decided to sharing IPD.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sodium Lactate and 3% NaCl in people with Septic Shock and Intracranial Hypertension, run by University Hospital Pilsen at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Miroslav Kříž, MD (+420732850912, krizm@fnplzen.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

haemodynamic effects (time frame: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06634069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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