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 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT00968695
Eligibility Criteria:
Inclusion Criteria:
* Age above 18 years and less than 80 years.
* Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound.
* Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide
* Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.
Exclusion Criteria:
* Refractory Ascites (paracentesis requirements over 1 month.
* Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule\> 5 cm or three nodules\> 3 cm).
* History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt
* Gastrointestinal bleeding or bacterial infection documented in the past 15 days.
* Heart failure or structural heart disease.
* Organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy).
* Moderate or severe lung chronic disease.
* Transplant.
* Infection with human immunodeficiency virus.
* Active addiction to drugs.
* Mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy.
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00968695
Study Brief:
Protocol Section:
NCT00968695