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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT06562803
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 65 years.
2. Total bilirubin (TBIL) \> 12 mg/dL, 3.5\>INR ≥ 1.5.
3. Meets the diagnostic criteria for sepsis 3.0: confirmed or suspected infection with an increase in SOFA score by ≥ 2 points.
4. High inflammatory state: IL-6 \> 80 pg/ml.
5. Onset of sepsis within the past 72 hours.
Exclusion Criteria:
1. Presence of genetic metabolic liver disease.
2. Patients with liver malignancies or other concurrent cancers.
3. Pregnancy or lactation.
4. Patients with HIV infection or other immunodeficiency diseases.
5. Patients with autoimmune diseases, recent cardiovascular events leading to unstable infarction, or a history of organ transplantation.
6. End-stage organ failure:
End-stage chronic obstructive pulmonary disease, end-stage pulmonary heart disease, brain death, or persistent vegetative state, Grade IV hepatic encephalopathy.
End-stage renal disease or acute renal failure requiring CRRT. Inability to maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation, vasopressors, and steroid therapy.
7. Platelet count \< 50×10⁹/L, severe coagulopathy, or active bleeding.
8. Allergic reactions to extracorporeal circulation, hemoperfusion substances, or history of severe allergies.
9. Inability to comply with study protocols or refusal to sign the informed consent form.
10. Inability to attend regular follow-up visits according to the study schedule.
11. Any other conditions that, in the investigator's judgment, make the patient unsuitable for inclusion in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06562803
Study Brief:
Protocol Section:
NCT06562803