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

Status: Recruiting
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Contact Information
Primary
Miroslav Kříž, MD
krizm@fnplzen.cz
+420732850912
Backup
Marek Nalos, MD
marek.nalos@gmail.com
Time Frame
Start Date: 2024-11-24
Estimated Completion Date: 2027-10
Participants
Target number of participants: 40
Treatments
Experimental: Group 1
Patients suffering from septic shock who require fluid resuscitation get 0.5M HSL (containing 504mM of sodium and lactate)
Active_comparator: Group 2
Patients suffering from septic shock who require fluid resuscitation get 3% NaCl (containing 513mM of sodium and chloride)
Sponsors
Leads: University Hospital Pilsen

This content was sourced from clinicaltrials.gov