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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT04991259
Eligibility Criteria:
Inclusion Criteria:
\- Patients with acute liver failure defined patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease with documented cerebral edema on CT-scan and arterial ammonia \>150 ug/dL.
Exclusion Criteria:
1. Age \<18 or \> 70 years
2. Hepatocellular Carcinoma
3. Active untreated Sepsis/DIC
4. Hemodynamic instability requiring high dose of vasopressors
5. Post-resection and malignancy related liver failure
6. Coma of non-hepatic origin
7. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
8. Patients already meeting emergency criteria for immediate initiation of dialysis at the time of randomization (serum potassium\>6 meq/lt, metabolic acidosis ph\<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)
9. Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit
10. Extremely moribund patients with an expected life expectancy of less than 24 hours
11. Pregnancy related liver failure
12. Patients with significant renal dysfunction meeting absolute criteria for initiation of dialysis
13. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
14. Patients being taken up for liver transplant
15. Refusal to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04991259
Study Brief:
Protocol Section:
NCT04991259