Study SOLACE SEPSIS (MJIP1_0)

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

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Intracranial Hypertension
• Intervention / Treatment: Drug: Sodium Lactate; Drug: 3% NaCl

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Miroslav Kříž, MD; Phone Number: +420732850912; Email: krizm@fnplzen.cz
• Study Contact Backup: Name: Marek Nalos, MD; Email: marek.nalos@gmail.com

Study Locations

• Czechia
  • Czech Republic
    • Pilsen, Czech Republic, Czechia, 30100
      • Recruiting
      • University Hospital Pilsen
      • Contact: Miroslav Kříž, MD; Phone Number: +420 732 850 912; Email: krizm@fnplzen.cz
      • Contact: Marek Nalos; Email: mareknalos@gmail.com
      • Principal Investigator: Miroslav Kříž, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Patients suffering from septic shock who require fluid resuscitation get 0.5M HSL (containing 504mM of sodium and lactate)	Drug: Sodium Lactate; 0.5M HSL (containing 504mM of sodium and lactate); Other Names: 0.5M natrii lactatis
Active Comparator: Group 2; Patients suffering from septic shock who require fluid resuscitation get 3% NaCl (containing 513mM of sodium and chloride)	Drug: 3% NaCl; active compartor 3% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus
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	parameters measured within the last 24 hours prior to start of infusion and within 24 hours after the study fluid infusion.
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).	30 days after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Assess safety and potential anti-inflammatory effects, effects on vasopressor requirement, shock resolution and selected organ function of an intravenous fluid bolus of 0.5M HSL (3ml/kg over 30 minutes) against 3% NaCl (3ml/kg over 30 minutes) in patients with septic shock.	60 min after start of infusion

Collaborators and Investigators

• Sponsor: University Hospital Pilsen

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; intracranial hypertension
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic; Intracranial Hypertension; Organic Chemicals; Carboxylic Acids; Hydroxy Acids; Lactates; Sodium Lactate
• Other Study ID Numbers: EU CTR: 2024-517927-37-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet decided to sharing IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No