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:
NCT06771869
Eligibility Criteria:
Inclusion Criteria:
* APACHE II score of more than 12 calculated on admission.
* SOFA score of more than 2 calculated on admission.
* Septic patients who manifested by 2 or more of the following conditions:
1. Temperature \>38oC or \<36oC
2. Heart rate \>90 beats/min
3. Respiratory rate \>20 breaths/min or PaCO2 \<32mmHg.
4. White blood cell count \>12000/mm3, \<4000/mm3 or \>10% immature (band) forms.
* Mechanically ventilated patients for less than 48 hours and who were anticipated to be on MV for at least another 48 hours.
* Serum sodium concentration between 130 mmol/L and 150 mmol/L
Exclusion Criteria:
* Age less than 13 years and more than 70 years.
* Traumatic brain injury.
* ICU admission diagnosis of diabetic ketoacidosis, hyperosmolar hyperglycemic state, Child-Pugh class C liver cirrhosis, pregnancy or anticipated survival of less than 24 hours.
* Patients undergoing renal replacement therapy (RRT).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
70 Years
Study:
NCT06771869
Study Brief:
Protocol Section:
NCT06771869