Clinical trials: Sodium Depletion
Hypervolemic and Euvolemic Hyponatremia
Samsca Post Marketing Surveillance Study
This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017).
- Trial name
- Samsca PMS (NCT02722863)
- Where
- 4 sites in South Korea
- Volunteers
- 908 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
SIAD - Syndrome of Inappropriate Antidiuresis
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
Hyponatremia due to SIAD is frequently insufficiently corrected by fluid restriction alone, which remains the first-line therapy but is often poorly tolerated. Urea supplementation is recommended as second-line therapy.
- Trial name
- UREA-BIVA (NCT07528365)
- Testing
- urea
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- University of Turin, Italy
Hyponatremia, Hyponatremia With Extracellular Fluid Depletion
Hypotonic Hyponatremia: Criteria for the Correct Classification of Its Etiology and of Patient Volume Status
Hyponatremia is the most frequent electrolyte disorder encountered in clinical practice. The patient approach, however, is still problematic, above all because hyponatremia is a manifestation correlated to various pathological…
- Conditions
- Hyponatremia, Hyponatremia With Extracellular Fluid Depletion, Hyponatremia With Normal Extracellular Fluid Volume, Hyponatremia With Excess Extracellular Fluid Volume
- Trial name
- NCT04402190
- Where
- Italy
- Volunteers
- 123 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Hyponatremia
An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion.
- Trial name
- NCT00379847
- Testing
- conivaptan
- Where
- 28 sites in United States, Israel and 1 more
- Volunteers
- 251 people
- Sponsor
- Cumberland Pharmaceuticals
Healthy
Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
The impact of sodium intake on plasma drug concentrations has previously been reported in the literature for verapamil and quinidine but, to the investigators' knowledge, never with renin-angiotensin system blockers such as AT1R…
- Trial name
- NCT00310778
- Testing
- high sodium diet, low sodium diet, ramipril 10 mg
- Where
- France
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hyponatremia
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02012959
- Testing
- Tolvaptan
- Where
- 7 sites in United States, Italy and 1 more
- Volunteers
- 9 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia With Normal Extracellular Fluid Volume
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
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.
- Trial name
- NCT00660959
- Testing
- lixivaptan
- Where
- 71 sites in United States, Belgium and 4 more
- Volunteers
- 106 people
- Sponsor
- CardioKine Inc.
Liver Disease, Hyponatremia
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
- Trial name
- NCT00851227
- Testing
- conivaptan hydrochloride
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
This Study is to Understand the Current Practice of Sodium Management in Acute Neurological Injury
Sodium Management in Acute Neurological Injury
This multicenter, observational, study will enroll severe neurologically injured patients both prospectively and retrospectively.
- Trial name
- SANI (NCT01558843)
- Where
- 17 sites in United States
- Volunteers
- 400 people
- Sponsor
- Washington University School of Medicine
Congestive Heart Failure
DILIPO (DILutIonal HyPOnatremia)
Primary: To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia other than SIADH or cirrhosis Secondary: To assess the long-term efficacy of SR121463B in maintaining normonatremia…
- Trial name
- NCT00274326
- Testing
- SR121463B
- Where
- 15 sites in United States, Argentina and 13 more
- Volunteers
- 150 people
- Sponsor
- Sanofi
Hemodynamics, Hyponatremia
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes
Twenty adult volunteers will be administered Pico-Salax in the usual fashion for colonoscopy with intense monitoring of serum and urine chemistry and hemodynamics.
- Trial name
- NCT00885430
- Testing
- Pico-Salax
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Queen's University
Euvolemic Hyponatremia
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
- Trial name
- NCT00876798
- Testing
- Lixivaptan
- Where
- 90 sites in United States, Belgium and 6 more
- Volunteers
- 206 people
- Sponsor
- CardioKine Inc.
Hyponatremia, Pituitary Adenoma
Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
Delayed post-operative hyponatremia occurs in 5-20% of patients following pituitary surgery and typically occurs on post-operative day 5-10.This decline in sodium can occur rapidly and have serious consequences such as altered…
- Trial name
- NCT02727686
- Testing
- Water Load (WL) Post-Operative Day 1
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
Hyponatremia
Analysis of the Epidemiology, Clinical Presentation and Therapy as Well as Therapy-associated Risk of Demyelination Syndrome in Patients With Profound Hyponatremia in the Emergency Department
Hyponatremia is a frequent cause for presentation to the emergency department (ED). While patients with chronic hyponatremia often exhibit minor symptoms, acute development of hyponatremia can lead to global cerebral edema…
- Trial name
- ProfHN_in_ZNA (NCT06781710)
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- University of Cologne
Cardiorenal Syndrome
Association Between Renal and Right Cardiac Functions After Urinary Sodium Depletion Following Cardiac Surgery
Following cardiac surgery, right ventricular function may be altered leading to increase central venous pressure and decrease in renal blood flow.
- Trial name
- DECONGEST (NCT03684876)
- Testing
- diuretic use
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Liver Cirrhosis, Hyponatremia
Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia
This is a phase IV, open-label, prospective cohort study for 7 days.The recommended starting dose of tolvaptan is 15 mg daily orally.
- Trial name
- OASIS (NCT01850940)
- Testing
- Tolvaptan, conventional thearpy
- Where
- 19 sites in China
- Volunteers
- 98 people
- Sponsor
- Beijing Friendship Hospital
Hyponatremia, Hypernatremia
Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial
Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid).
- Trial name
- NCT00734214
- Testing
- 0.9% NaCl, 0.45%NaCl
- Where
- Canada
- Volunteers
- 258 people, healthy volunteers welcome
- Sponsor
- Hamilton Health Sciences Corporation
Hyponatremia, Metabolic Bone Disease
The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.
The study investigates the association between normalization of serum sodium levels and bone markers in patients with epilepsy and chronic hyponatremia.
- Trial name
- NCT03371199
- Testing
- Sodium chloride
- Where
- Denmark
- Volunteers
- 21 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Hyponatremia
Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
In this study patients with hyponatremia, defined as a serum sodium < 126 mmol/L on admission to the hospital will be tested for muscular power by use of a hand grip dynamometer, for cognitive function by use of the…
- Trial name
- NCT04020926
- Where
- Switzerland
- Volunteers
- 8 people
- Sponsor
- Bürgerspital Solothurn
Hyponatremia, Euvolemia
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
- Conditions
- Hyponatremia, Euvolemia, Hypervolemia
- Trial name
- NCT00435591
- Testing
- Conivaptan
- Where
- 18 sites in United States, India and 1 more
- Volunteers
- 121 people
- Sponsor
- Cumberland Pharmaceuticals