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:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT03871894
Eligibility Criteria:
Inclusion Criteria:
Disease groups:
• Patients with liver cirrhosis (diagnosis established based on routine clinical, biochemical and at least radiological, endoscopic or histological parameters.) admitted in Liver coma Intensive care unit and those admitted in ward.
Disease controls:
* Patients with Acute liver failure (diagnosis established based on routine clinical, biochemical and at least radiological parameters) admitted in Liver coma Intensive care unit
* Patients with severe acute pancreatitis (diagnosis established based on routine clinical, biochemical and at least radiological parameters) admitted in Liver coma Intensive care unit
Healthy Controls:
* Healthy subjects- Relatives of patients with no known chronic diseases (Chronic obstructive pulmonary disease, Coronary artery disease, Type 2 diabetes, Hypertension, Hypothyroidism, Koch's disease) or not on any long term medications.
* Patients with liver cirrhosis (diagnosis established based on routine clinical, biochemical and at least radiological, endoscopic or histological parameters.) admitted in Liver coma Intensive care unit who require mechanical ventilation
Exclusion Criteria:
* Age\<18 years
* Active upper gastrointestinal bleeding
* If there are conditions which precluded IC, such as an FiO2 \>60 %, failure to cooperate, agitation, seizure activity, spasticity, or positive end-expiratory pressure (PEEP) \>10 mmHg.
* Pregnant women
* Refused to consent/ inability to obtain informed consent.
* Known long standing diabetic
* If there is any evidence of medical/surgical instability
* Hepatocellular carcinoma Extrahepatic malignancies
* With persistent gastrointestinal dysfunction and ileus
* Patients who would be readmitted to the ICU
* Known long standing diabetic
* Terminally ill patients on high inotropic support
* Acute liver failure
* If there is any evidence of medical/surgical instability
* If patients are taking any portion of nutrition by mouth.
* Pregnant women
* Refused to consent/ inability to obtain informed consent.
* Patient on CRRT- continuous renal replacement therapy
* Severe co morbidities such as Chronic kidney disease requiring maintenance dialysis, COPD and Cardiac pathologies (Acute myocardial infarction, heart failure, ).
* Hepatocellular carcinoma Extrahepatic malignancies
* Moribund patient with likely survival \<24 hours
* Patients enrolled in other drug trials.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03871894
Study Brief:
Protocol Section:
NCT03871894