Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT06634069
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06634069
Study Brief:
Protocol Section:
NCT06634069