Hyponatremia | Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites
Hyponatremia research study
What is the primary objective of this study?
The purpose of the study is to investigate the efficacy and safety for the management of hyponatremia and ascites in patients with liver cirrhosis.
Who is eligible to participate?
Inclusion Criteria: 1. 20 years of age or older 2. Patients with cirrhosis as diagnosed by liver biopsy or a combination of laboratory (thrombocytopenia), radiologic (cirrhotic feature of liver, splenomegaly, collateral shunt on US, CT, or MRI) and endoscopic findings (gastoesophageal varices or portal hypertensive gastropathy) 3. ≥ Grade 2 ascites who have already been treated with restricted salt diet within 3 month 4. Hyponatremia (Serum sodium ≥120 mEq/L and ≤130 mEq/L) 5. Written informed consent Exclusion Criteria: 1. Hypovolemic hyponatremia (Patients with hypotension or chronic heart failure) 2. Serum potassium concentration > 5.5 mEq/L 3. Serum bilirubin > 5.0 mg/dL 4. Blood coagulation factor < 40% or international normalized ratio (INR) > 2.3 5. Platelet count < 30,000/mm3 6. Serum creatinine > 3 mg/dL 7. Treatment within 2 weeks with vasopressin anlogues 8. Systolic blood pressure <80 mmHg 9. History of gastrointestinalesophageal varix bleeding variceal hemorrhage 10. Spontaneous bacterial peritonitis 11. Hepatic encephalopathy ≥ grade 3 12. History of Hepatocellular carcinoma treatment within 3month or viable tumor Viable hepatocellular carcinoma 13. Liver transplant 14. Previous treatment with transjugular intrahepatic portosystemic stent shunt (TIPS) 15. History of significant cardiac diseases such as recent myocardial infarction or ischemic diseases within 1 year of screening 16. Prolonged QTc interval of > 500 ms based on electrocardiography 17. Treatment within 2 weeks with substances or drugs that may either induce or significantly inhibit cytochrome P450 3A (ketoconazole, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, etc) 18. Pregnant or breast feeding 19. Patients with galactose intolerance or malabsorption (as production of the drug contains lactose) 20. HbA1Cc ≥ 9 % 21. Serious medical illness (e.g. heart failure, severe pulmonary disorders, alcohol dependence, malignant tumors, etc)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Tolvaptan15 - 60 mg/day for 28 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Tolvaptan groupForm : Tablet, Dosage: 15 mg, 30 mg or 60 mg, Frequency: once a day. Duration: 28days
Placebo groupForm : Tablet, Dosage: 15 mg, 30 mg or 60 mg, Frequency: once a day. Duration: 28days
Start Date: November 2012
Completed Date: February 2014
Phase: Phase 4
Primary Outcome: the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 28 after intervention
Secondary Outcome: the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 4
Study sponsors, principal investigator, and references
Principal Investigator: June Sung Lee, MD, PhD
Lead Sponsor: Konkuk University Medical Center
Collaborator: Inje University