RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Sodium Lactate
0.5M HSL (containing 504mM of sodium and lactate)
DRUG
3% NaCl
active compartor 3% NaCl
Locations (1)
University Hospital Pilsen
Pilsen, Czech Republic, Czechia