hyponatremia MedDRA version: 9.1 Level: HLGT Classification code 10014412
Conditions
Interventions
Trade Name: TOLVAPTAN
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Sponsors
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patient age 18 or older admitted at the Emergency Room that show a plasma sodium concentration below 130 mEq/l Are the trial subjects under 18? no Number of subjects for this age range: 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
Exclusion criteria: Persons with psychogenic polydipsia, head trauma, postoperative conditions, uncontrolled hypothyroidism or adrenal insufficiency, or any hyponatremic condition associated with the use of medications that could have been safely withdrawn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to identify a process for an early stratification of patients based on pathophysiological mechanisms underlying hyponatremia. After establishing the type of alteration will be possible to calculate the sodium deficit or volume excess and start the appropriate therapy which may include the use of tolvaptan;Secondary Objective: reduced time of hospitalization for correction of sodium plasma level;Primary end point(s): reaching a value of plasma sodium concentration > or equal to 135 mEq / L after therapy | — |
Countries
Italy
Outcome results
None listed