Could a simple salt solution save lives in septic shock?

NCT ID NCT06634069

Disease control Sponsor: University Hospital Pilsen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two fluids—sodium lactate and a concentrated saline solution—in 40 adults with septic shock. The goal is to see which one better supports blood flow and acid balance. Participants will receive either fluid in a double-blind setup, and researchers will measure heart function and blood chemistry.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Sodium lactate solution (0.5M) and 3% saline solution
What this could lead to: If this works, it could point toward a better fluid treatment for septic shock, potentially improving blood flow and acid balance in critically ill patients.
What could go wrong: This is a small, early-phase pilot study with only 40 participants, so results may not apply broadly. The treatments are given in a hospital setting and may not work better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects will be eligible for the trial if they meet all of the following criteria: 1. Age criteria: 18 - 90 years 2. Septic shock - Sepsis 3 criteria : 1. acute change in total SOFA score ≥ 2 due to infection 2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg 3. blood lactate level ≥ 2 mmol/L within last 24 hours 3. Likely need for fluid resuscitation 1. 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 2. 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% 4. Signed the relevant informed consent form Exclusion Criteria: * Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Poor transthoracic echo windows 2. Actual body weight \> 160 kg 3. Hypernatremia: \[Na\] \> 150 mEq/L 4. Cardiac tamponade 5. Uncorrected severe valvular heart disease or life-threatening arrhythmia 6. Moribund patients likely to die before the study protocol is completed 7. Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH \< 7.0, K \> 7.0mmol/L 8. Severe liver dysfunction defined by total serum bilirubin \> 120 umol/l 9. Pregnancy and lactation

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Conditions

The condition(s) this trial relates to.

intracranial hypertension toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial hypertension Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Could a simple salt solution save lives in septic shock?

What the study statuses mean