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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT07172451
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years.
* Diagnosis of sepsis according to Sepsis-3 definition.
* Scheduled for emergency non-cardiac surgery under general anesthesia.
* Randomization and study intervention can be initiated before skin incision.
* Provision of written informed consent by patient or legal representative.
Exclusion Criteria:
* Cardiac surgery, neurosurgery, or procedures requiring cardiopulmonary bypass.
* Severe preexisting cardiac dysfunction (ejection fraction \<30%, NYHA class IV).
* End-stage renal disease requiring chronic renal replacement therapy.
* Known severe hepatic failure (Child-Pugh C).
* Known allergy or contraindication to study fluids (gelatin solution or crystalloid solution).
* Pregnant or lactating women.
* Participation in another interventional trial within the past 30 days.
* Life expectancy \<24 hours or decision to withhold/withdraw life-sustaining treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07172451
Study Brief:
Protocol Section:
NCT07172451