Study SOLACE SEPSIS

Last updated: April 8, 2025
Sponsor: University Hospital Pilsen
Overall Status: Active - Recruiting

Phase

2

Condition

Vascular Diseases

Sepsis And Septicemia

Stress

Treatment

Sodium Lactate

3% NaCl

Clinical Study ID

NCT06634069
EU CTR: 2024-517927-37-00
  • Ages 18-90
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 :

  3. acute change in total SOFA score ≥ 2 due to infection

  4. use of vasopressor drug to maintain target mean arterial pressure ≥ 65mmHg

  5. blood lactate level ≥ 2 mmol/L within last 24 hours

  6. Likely need for fluid resuscitation

  7. poor peripheral perfusion as evidenced by 2 out of 4: i. peripheralcyanosis 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

  8. dynamic assessment of preload responsiveness as evidenced by 1 out of 3:i. positive passive leg raising test ii. pulse pressure variation and / orstroke volume variation2, both > 12% iii. distensibility index of inferiorvena caval diameter > 12%

  9. Signed the relevant informed consent form

Exclusion

Exclusion Criteria:

  • Subjects will not be eligible for the trial if they meet any of the followingcriteria:
  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 acutehemodialysis/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 Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Sodium Lactate
Phase: 2
Study Start date:
November 24, 2024
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • University Hospital Pilsen

    Pilsen, 30100
    Czech Republic

    Site Not Available

  • University Hospital Pilsen

    Pilsen, Czech republic 30100
    Czechia

    Active - Recruiting

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