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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01373606
Eligibility Criteria:
Inclusion Criteria:
\- Patients who were diagnosed with HRS type 1 according to the diagnostic criteria of HRS and whose serum creatinine value (SCr) doubled at 2.5 mg/dL or greater within 2 weeks or whose 24h creatinine clearance (Ccr) decreased by half at less than 20 mL/min.
Patients should meet all the following 5 criteria:
\[Modified International Ascites Club's Diagnostic criteria of HRS\]
1. Chronic or acute liver disease with advanced hepatic failure and portal hypertension.
2. Low glomerular filtration rate (SCr \>1.5 mg/dL or 24h Ccr \<40 mL/min)
3. Absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug
4. No sustained improvement in renal function (decrease in SCr to 1.5 mg/dL or less or increase in 24h Ccr to 40 mL/min or more) following diuretic withdrawal and expansion of plasma volume with 1,500 mL/24h of isotonic saline for 24 to 48h.
5. Protein urea \<500 mg/dL, and no ultrasonographic evidence of obstructive uropathy or parenchymal renal disease
* Age; 20 to 79 years
Exclusion Criteria:
* Cr value ≥5 mg/dL
* Child-Pugh Score ≥14
* Fulminant hepatitis
* Septic shock
* Hepatocellular carcinoma that does not meet the Milan Criteria
* Acute renal failure caused by contrast medium
* Chronic renal failure
* Bradycardia (heart rate \<50/min)
* Hyponatraemia (serum Na \<120 mEq/L)
* Ischemic heart diseases (angina pectoris, myocardial infarction), heart failure or clinically relevant arrhythmia
* Poor-controlled hypertension
* Arteriosclerosis obliterans or peripheral vascular disorder
* Cerebrovascular disorder
* Respiratory diseases such as chronic obstructive pulmonary disease
* Pregnant or possibly pregnant women and patients who or whose partner desire -pregnancy during the study period
* Patients considered by the investigator or sub-investigator as unsuitable to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT01373606
Study Brief:
Protocol Section:
NCT01373606