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)
View Full Details on ClinicalTrials.gov
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NCT06634069
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