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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT03941405
Eligibility Criteria:
Inclusion Criteria:
* Patients included into the study must meet all the following criteria:
This study will include patients with liver cirrhosis and hypervolemic hyponatremia (serum sodium\<130 mEq/L) admitted to hospital for any decompensation of the disease. Patients will be enrolled if hyponatremia persists after 3 days of diuretic withdrawal and fluid restriction. Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner. Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
Exclusion Criteria:
1. Patients with Acute kidney injury 1B or higher;
2. Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate \<60ml/min for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate \> 30 mg/24h; Albumin-to-creatinine ratio \> 30 mg/g), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging.
3. Previous kidney or liver transplant;
4. Active infection apart from spontaneous bacterial peritonytis based on positive culture (blood, urine, sputum or other samples) or by the following criteria:
1. Urinary infections: signs of systemic inflammation and more than 10 leukocytes per high-power field in urine;
2. Pneumonia: compatible symptoms (cough, purulent sputum, chest pain, shortness of breath) and presence of new infiltrates on chest x-ray;
3. Skin/soft tissue infection: physical exam findings of swelling, erythema, heat and tenderness in the skin;
4. Acute cholangitis: signs of systemic inflammation1, compatible symptoms (right upper quadrant pain and jaundice) and radiological data of biliary obstruction, analytical data of cholestasis;
5. Suspected bacterial infection: signs of systemic inflammation1 but no identifiable origin of this infection (polymorphonuclear cells in ascitic and pleural fluid \< 250/mm3, normal urine sediment and chest Xray) After 48 hours of appropriate antibiotic treatment patients can be enrolled.
5. Spontaneous bacterial peritonitis.
6. Hypo or hyperthyroidism not controlled under adequate treatment.
7. Associated heart failure, defined as a New York Heart Association (NYHA) classification III or IV or heart failure with reduced ejection fraction (LVEF\<40%). Previously known structural cardiomyopathy including ischemic cardiomyopathy, restrictive cardiomyopathy or valvular cardiomyopathy.
8. Hepatocellular carcinoma beyond Milan criteria.
9. Severe alcoholic hepatitis defined by Maddrey score ≥32 and/or MELD score ≥ 20
10. ACLF with two or more organ failures
11. Treatment with diuretics (furosemide or spironolactone), albumin infusion, somatostatin or terlipresin in the previous 3 days.
12. Symptomatic hyponatremia (manifested by cardio-respiratory distress, abnormal and deep somnolence, seizures or coma) with serum sodium below 120 mEq/L.
13. Previous known hypersensitivity to human albumin
14. Refuse to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03941405
Study Brief:
Protocol Section:
NCT03941405