Clinical trial NCT01552590: Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
Official title: Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hyponatremia and Extracellular Fluid in Cirrhotic
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Subjects aged ≥ 20 years
2. Subjects who have been diagnosed with hyponatremia \[serum sodium \< 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction\]
3. Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
4. Subjects who have diagnosed with cirrhosis.
5. Subject or their legally acceptable representatives are able to provide informed consent/assent.

Exclusion Criteria:

1. Subject who has ascites by other causes (Tbc, CHF, malignancy, or renal disease) acute severe hyponatemia : Serum Na level \< 120 mmol/L and Doubt of symptom caused by hyponatremia and the case which should raise serum Na level urgently based on the investigator's judgment international normalized ratio (INR) \>3.0 serum sodium ≥135 mmol/L serum potassium \> 5.5 mmol/L Creatinine ≥ 2.0 mg/dL Hepatorenal syndrome defined as 'New International Ascites Club's diagnostic criteria' systolic arterial pressure of \< 80 mmHg recent myocardial infarction (\< 6 month) spontaneous bacterial peritonitis gastrointestinal bleed ( ≤7 days from randomization) ongoing hepatic encephalopathy of \> grade1 known hepatocellular carcinoma intractable ascites
2. Subject who requiring urgent intervention to raise serum sodium acutely
3. Subject who are unable to sense or to respond appropriately to thirst
4. Subject with hypovolemic hyponatremia
5. Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
6. Subject who are anuric as no benefit is expected
7. Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8. Subject who has fluid depletion
9. Female subjects who are pregnant or lactating
10. Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason

Primary outcomes:
measure: Serum Na
timeFrame: 2 weeks (Baseline, Day 14)
Secondary outcomes:
measure: BCM (body composition monitoring)
timeFrame: 7 days
measure: body weight
timeFrame: 7 days
measure: A composite endpoint of ascites worsening
timeFrame: in case
measure: Serum Na normalization rate
timeFrame: 14 days
measure: Biochemistry
timeFrame: 7 days
measure: ECG
timeFrame: 7 days
measure: Adverse event
timeFrame: Daily
measure: Physical examination
timeFrame: 7 days
measure: Vital signs
timeFrame: Daily
measure: Blood coagulation
timeFrame: 7 days
measure: Urinalysis
timeFrame: 7 days
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Hallym Univ. Chuncheon Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang Univ. Bucheon Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
References: