Tolvaptan for In-hospital Hyponatremia

Launched by MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH · Jun 30, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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, 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.