Status:
TERMINATED
Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Hyponatremia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Hyponatremia is a condition in which there is a low sodium level in the blood. Individuals with cirrhosis may develop low blood sodium as a complication of their liver disease. In these patients, the ...
Detailed Description
As per hyponatremia standard treatment of care, all patients considered for the study will have had diuretic therapy discontinued for at least 1 day prior to the screening visit and received volume ex...
Eligibility Criteria
Inclusion
- Cirrhosis
- Screening within 24 hours of admission
- Na level less than 130mEq/L
- Presence of fluid overload with either history of ascites or edema
- Cr \< 2.0mg/dl
- Planned length of stay after randomization of at least 24 hours
- Anticipated survival of at least 8 days
- Ability to provide informed consent
Exclusion
- Hospitalization greater than 24 hours at screening
- Depletional hyponatremia
- Hyponatremia due to hyperglycemia
- Acute and transient hyponatremia associated with head trauma or post-operative states
- Hyponatremia due to primary polydipsia, adrenal insufficiency, or hypothyroidism
- Urgent need for treatment of hyponatremia with saline or hypertonic saline
- Treatment with demeclocycline, lithium chloride, and urea
- Cr greater than 2.0mg/dl
- Stage 3 or 4 hepatic encephalopathy
- Inability to provide informed consent
- Planned discharge within 24 hours
- Anticipated survival less than 8 days
- GI bleeding within one month of enrollment
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01890694
Start Date
March 1 2012
End Date
March 1 2015
Last Update
December 11 2017
Active Locations (1)
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1
NYU Langone Medical Center
New York, New York, United States, 10016