Conditions: Hyponatremia Dilutional Hyponatremia Inappropriate ADH Syndrome
Keywords: Hyponatremia Dilutional Hyponatremia Euvolemic Hyponatremia Hypervolemic Hyponatremia Fluid Restriction Tolvaptan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 124
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction. The study will also test if tolvaptan is better than fluid restriction in treating the symptoms of hyponatremia in hospitalized patients.

Detailed description:

Arms:
arm 1: Oral tablet without fluid restriction. After the initial dose, daily dose may be titrated based on response. arm 2: Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based response.

Interventions: intervention 1: tolvaptan intervention 2: Fluid Restriction
Intervention descriptions: intervention 1: 15 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response. intervention 2: Placebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response.

Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo "dose"

Protocol document: