This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and hyponatremia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
Hallym Univ. Chuncheon Sacred Heart Hospital
Bucheon-si, South Korea
Soonchunhyang Univ. Bucheon Hospital
Bucheon-si, South Korea
Wonju Christian Hospital
Wŏnju, South Korea
Serum Na
Time frame: 2 weeks (Baseline, Day 14)
BCM (body composition monitoring)
Time frame: 7 days
body weight
Time frame: 7 days
A composite endpoint of ascites worsening
Time frame: in case
Serum Na normalization rate
Time frame: 14 days
Biochemistry
Total protein, Albumin, ALP, ALT, AST, r-GT, BUN, Creatinine, Glucose, Cl, K, Na, Ca, Total bilirubin, Uric acid), Hematology (WBC count, Hemoglobin, Hematocrit, Platelets, Serum osm, NT pro-BNP
Time frame: 7 days
ECG
Time frame: 7 days
Adverse event
Time frame: Daily
Physical examination
HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae
Time frame: 7 days
Vital signs
Time frame: Daily
Blood coagulation
PT, INR
Time frame: 7 days
Urinalysis
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Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm
Time frame: 7 days