View clinical trials related to Hyponatremia.
Filter by:This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy + placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in each group) patients are to be enrolled randomly into Tolvaptan group or placebo group. Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day), while those in control group receiving standard therapy + placebo. The starting dose of tolvaptan is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg according to a certain titration scheme based on patients' response of serum sodium level. The study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study treatment (day 1 to day 7 ). After study treatment, subjects will be Followed-up on safety events on day 14 - 16. The Primary Efficacy Variable is the change of serum sodium from baseline. For patients with Congestive Heart Failure (CHF) or hepatic cirrhosis, change of body weight, fluid balance and symptoms improvement of CHF and hepatic edema will be assessed as secondary efficacy variables.
The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.
The primary objective of this study is to compare the mean serum sodium at 48 hours following the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in children requiring maintenance IV fluid administration.
Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children. Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5% dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children receiving intravenous maintenance fluids.
Women are at greater risk for exercise-induced hyponatremia (low blood sodium concentration) and this risk has been attributed to their lower body weight and size, excess water ingestion and longer racing times relative to men. While these factors contribute to the greater incidence of hyponatremia in women, it is likely that their greater levels of estradiol in plasma and/or tissue also play a role in increasing the risk of hyponatremia in women. More importantly, estradiol may also leave women more susceptible to the extreme consequences of hyponatremia (i.e. brain damage, death). Hyponatremia is generally attributed to inappropriately elevated levels of the hormone arginine vasopressin (AVP). AVP is the most important hormone controlling water retention in the kidney. Earlier studies in our laboratory have demonstrated that estradiol lowers the threshold for thirst sensation and AVP release during exercise. The purpose of these studies is to test the hypotheses that in women with a history of hyponatremia, estradiol lowers the thresholds for thirst and AVP release, leading to greater fluid retention, lower blood sodium concentration during endurance exercise in the heat. However, we further hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on the regulation of thirst and AVP, normalize fluid retention, and serum sodium concentration during endurance exercise in the heat. In women without a history of hyponatremia, we expect that estradiol administration will lower the thresholds for thirst and AVP release, but will not increase fluid retention or reduce blood sodium concentration during endurance exercise in the heat. We hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on thirst and AVP, but have no effect on fluid retention or serum sodium concentration during endurance exercise in the heat. To test these hypotheses, women will perform endurance exercise in the heat under three hormonal conditions: 1) during Gonadotropin-releasing hormone (GnRH) antagonist alone--which will suppress estradiol and progesterone; 2) during GnRH antagonist+estradiol; and 3) during GnRH antagonist+estradiol+ progesterone. During exercise, fluid will be replaced with either water or a carbohydrate-electrolyte beverage (random assignment).
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement for an appropriate and riskless treatment of hyponatremia. This study try to establish an algorithm handling a prospective clinical categorization of hyponatremia and approving together the start of an appropriate symptomatic therapy.
Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia