Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to investigate the efficacy and safety for the management of hyponatremia and ascites in patients with liver cirrhosis.


Clinical Trial Description

Patients with advanced cirrhosis frequently develop dilutional hyponatremia due to impairment of their renal ability to eliminate solute-free water. Although the pathophysiology of this disorder is multifactorial, an increased hypersecretion of arginine vasopressin (AVP) is a major factor. The prevalence of hyponatremia in cirrhosis, as defined by a serum sodium level of 130 mmol/L is reported to be about 20%, and there are several lines of evidence that hyponatremia is a risk factor for the development of hepatic encephalopathy, and that it predicts a poor quality of life independent of liver function. Hyponatremia also predicts short-term mortality in cirrhotic patients awaiting liver transplantation. The principle of the management of hypervolemic hypona- tremia is to induce a negative water balance, with the aim of normalizing the increased total body water, which would result in an improvement in serum sodium concentration. Fluid restriction is the most widely accepted nonpharmacological therapy, but its efficacy is very limited. The administration of hypertonic sodium chloride has been common in severe hypervolemic hyponatremia, but its effect is only partial and short lived; moreover, additional expansion of fluid can worsen ascites and edema. Therefore, the pathophysiologically oriented treatment of hyponatremia focuses on inhibiting the actions of AVP. Recently, antagonists of the V2 receptors of vasopressin has been proposed to manage hyponatremic patients, such as heart fauilure, syndrome of inappropriate antidiuretic hormone or liver cirrhosis. Especially, a lot of hyponatremic patients with cirrhosis had ascites, and some of them had intractable ascites. In these patients, antagonists of the V2 receptors of vasopressin including tolvaptan might have beneficial effect in enhancing not only hyponatremia , but also ascites ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01716611
Study type Interventional
Source Konkuk University Medical Center
Contact Won Hyeok Choe, MD
Phone 82-2-2030-7506
Email 20050101@kuh.ac.kr
Status Not yet recruiting
Phase Phase 4
Start date November 2012
Completion date February 2014

See also
  Status Clinical Trial Phase
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Recruiting NCT04561531 - Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia. N/A
Terminated NCT02012959 - Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia Phase 3
Recruiting NCT02936167 - Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children N/A
Completed NCT00621348 - Maintenance Intravenous Fluids in Children Phase 3
Terminated NCT03703713 - Colloid Osmotic Pressure and Osmolality in Hyponatremia
Completed NCT02926989 - Intravenous Fluids in Hospitalised Children Phase 4
Terminated NCT02959411 - Tolvaptan for Advanced or Refractory Heart Failure Phase 4
Completed NCT02573077 - An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
Withdrawn NCT02667977 - Reexamining Hypotonic Intravenous Fluid Use N/A
Terminated NCT01708811 - Hyponatremia and Myometrium Contractility. An Invitro Study N/A
Completed NCT01456533 - Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients N/A
Withdrawn NCT01326429 - Frequency and Origin of Dysnatremias in the Emergency Department N/A
Terminated NCT01227512 - Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia Phase 3
Recruiting NCT06013800 - Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
Terminated NCT04020926 - Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
Completed NCT02545101 - An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH N/A
Withdrawn NCT02442674 - A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia Phase 3
Terminated NCT02215148 - Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients N/A
Recruiting NCT01748331 - The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia N/A