RecruitingPhase 2NCT06634069

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


Sponsor

University Hospital Pilsen

Enrollment

40 participants

Start Date

Nov 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria10

  • 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 Criteria10

  • 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

Interventions

DRUGSodium Lactate

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

DRUG3% NaCl

active compartor 3% NaCl


Locations(1)

University Hospital Pilsen

Pilsen, Czech Republic, Czechia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06634069


Related Trials