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NCT Number: NCT06634069

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Pilsen

Pilsen, Czech Republic, 30100, Czechia

Location status: Recruiting

Location contact

Marek Nalos

CONTACT

[email protected]

Miroslav Kříž, MD

CONTACT

[email protected]

+420 732 850 912

Miroslav Kříž, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sodium lactate

Drug

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

Other names: 0.5M natrii lactatis

3% NaCl

Drug

active compartor 3% NaCl

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. acid-base effect

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

    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

  2. anti-inflammatory effect

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

    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

  3. Safety - Incidence of adverse events and reactions

    Time frame: 30 days after intervention

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marek Nalos, MD

CONTACT

[email protected]

Miroslav Kříž, MD

CONTACT

[email protected]

+420732850912

Sponsors and collaborators

Lead sponsor

University Hospital Pilsen

Other

Registry information

Official study 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

Acronym: MJIP1_0

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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