Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia (NCT01890694) | Clinical Trial Compass
TerminatedPhase 4
Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia
United States2 participantsStarted 2012-03
Plain-language 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 presence of low blood sodium may exacerbate other complications such as encephalopathy, resulting in confusion, drowsiness, or coma. It may also affect the ability of the body to fight infection. In certain cases, cirrhotic patients may be hospitalized for the treatment of their low blood sodium.
The drug tolvaptan is currently FDA approved for the treatment of hyponatremia in patients with cirrhosis. Although it has been shown to increase the sodium level, the clinical trials that led to its approval did not otherwise assess clinical benefit of the drug.
This study is designed to determine whether patients with cirrhosis derive a clinical benefit when they receive tolvaptan for the treatment of hyponatremia within 2 days of admission. Specifically, whether it is associated with shortened length of stay and improvement in other complications of cirrhosis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Length of Hospital Stay
Timeframe: participants will be followed for the duration of hospital stay, an expected average of 2 weeks