Phase
Condition
Vascular Diseases
Sepsis And Septicemia
Stress
Treatment
Sodium Lactate
3% NaCl
Clinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 ≥ 65mmHg
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. 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
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%
Signed the relevant informed consent form
Exclusion
Exclusion Criteria:
- Subjects will not be eligible for the trial if they meet any of the followingcriteria:
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 acutehemodialysis/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
Study Design
Study Description
Connect with a study center
University Hospital Pilsen
Pilsen, 30100
Czech RepublicSite Not Available
University Hospital Pilsen
Pilsen, Czech republic 30100
CzechiaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.