A PILOT STUDY TO EVALUATE THE INCIDENCE OF HYPONATREMIA IN A MEDICAL-SURGICAL HOSPITAL AND TO EXPLORE THE EFFICACY AND SAFETY OF TOLVAPTAN IN THE CLINICAL PRACTICE - Tolvaptan for in-hospital hyponatremia

• Conditions: Hyponatremia; MedDRA version: 14.1Level: PTClassification code 10021036Term: HyponatraemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2010-024431-17-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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, or current alcohol abuse; - Uncontrolled diabetes mellitus defined as fasting glucose >300mg/dL; - Urinary tract obstruction except BPH if non-obstructive; - Terminally ill or moribund condition with little chance of short-term survival; - Serum creatinine >3.5 mg/dL; - Serum sodium <120 mEq/L with associated neurologic impairment, i.e. symptoms such as apathy, confusion, seizures; - Patients with progressive or episodic neurologic disease such as multiple sclerosis or history of multiple strokes; - Child-Pugh score greater than 10 (unless approved); - Patients receiving intravenous fluids at a rate greater than KVO (Keep Vein Open); - Hyponatremia due to lab artifacts; - Patients receiving AVP or its analogs for treatment of any condition; - Patients receiving within 7 days of randomization, other medications for treatment of hyponatremia specifically: demeclocycline, lithium carbonate or urea; - Patients likely requiring IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study; - Severe pulmonary artery hypertension; - Hyponatremia should not be the result of any medication that can safely be withdrawn.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified