Tolvaptan for In-hospital Hyponatremia (NCT01386372) | Clinical Trial Compass
TerminatedPhase 2
Tolvaptan for In-hospital Hyponatremia
Stopped: futility
Italy3 participantsStarted 2011-06
Plain-language summary
Hyponatremia is a common electrolyte disorder encountered in hospitalized patients. A preliminary, observational, feasibility analysis finalized to assess retrospectively the incidence of hyponatremia (Serum sodium \< 135 mEq/L) in a general medical-surgical hospital and the distribution of the cases of hyponatremia among different referral units showed that over one year observation there were more than 1500 cases of hyponatremia. Conventional therapy for hyponatremia depends on its causes, speed of onset, extracellular fluid volume status, and severity. Treatment consists in fluid restriction, normal or hypertonic saline, furosemide. Recent development of arginine vasopressin antagonists has provided a new therapeutic option for treatment of hyponatremia.Tolvaptan, an orally administered, nonpeptide, selective vasopressin V2 receptor antagonist reported to increase free water clearance and limit fluid retention in subjects with congestive heart failure or liver cirrhosis, has been also shown to be effective in the treatment of chronic hyponatremia in patients with SIADH, chronic heart failure, liver cirrhosis. Thus the investigators designed a clinical study to explore the incidence of severe hyponatremia in hospitalized patients in the setting of large general hospital and to evaluate whether tolvaptan is effective and safe in increasing serum sodium concentration in patients with normovolemic and hypervolemic hyponatremia in the setting of daily clinical practice. Moreover this study may help understand the cost-effectiveness of tolvaptan therapy compared to traditional treatments of hyponatremia.
Who can participate
Age range
18 Years – 80 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:
* Non artifactual hyponatremia in euvolemic or hypervolemic states, defined as serum sodium \<135 mEq/L confirmed in at least 2 consecutive evaluations;
* 18 years of age or older;
* Able to give written Informed Consent.
Exclusion Criteria:
* Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods;
* Hyponatremia in hypovolemic states;
* Acute and transient hyponatremia associated with head trauma or post-operative state;
* Hyponatremia due to uncontrolled hypothyroidism or uncontrolled adrenal insufficiency;
* Cardiac surgery within 30 days prior to the potential study enrollment, excluding percutaneous coronary interventions;
* History of a myocardial infarction within 30 days prior to the potential study enrollment;
* History of sustained ventricular tachycardia or ventricular fibrillation within the last 30 days, unless in the presence of an automatic implantable cardioverter defibrillator;
* Severe angina including angina at rest or at slight exertion and/or unstable angina;
* History of a cerebrovascular accident within the last 30 days;
* Subjects with psychogenic polydipsia may not be included, however subjects with other psychiatric illness may be included;
* Systolic arterial blood pressure \<90 mmHg;
* History of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril);
* History of drug or medication abuse within the past year,…
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
Changes from baseline in proportion of subjects with normonatremia at 6 month.
Timeframe: At 1,2,3,4 and 10 day, and at 1,2,4 and 6 month..
2
Changes from baseline in serum sodium levels from basal at 6 months.
Timeframe: At 1,2,3,4, 10 day and at 1,2,4 and 6 month..
Trial details
NCT IDNCT01386372
SponsorMario Negri Institute for Pharmacological Research