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.
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, 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, 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
Hyponatremia
Maintenance Intravenous Fluids in Children
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.
- Trial name
- NCT00621348
- Testing
- Isotonic fluid, Hypotonic fluid
- Where
- India
- Volunteers
- 167 people
- Sponsor
- All India Institute of Medical Sciences
Hyponatremia
Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia
Hyponatremia is a condition in which there is a low sodium level in the blood. Individuals with cirrhosis may develop low blood sodium as a complication of their liver disease.
- Trial name
- NCT01890694
- Testing
- Tolvaptan, Hepatic Encephalopathy Assessment, Quality of Life Assessment
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- NYU Langone Health
Hyponatremia
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.
- Trial name
- NCT01451411
- Testing
- Conivaptan hydrochloride
- Where
- 3 sites in United States, Colombia
- Volunteers
- 4 people
- Sponsor
- Cumberland Pharmaceuticals
Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain
In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in oncology patients was developed.
- Trial name
- ALGA (NCT02548845)
- Where
- 4 sites in Spain
- Volunteers
- 70 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate…
- Trial name
- SAMPLE (NCT02545101)
- Where
- 7 sites in Germany, Spain
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Electrolyte Imbalance, Hyponatremia
V2 Receptor Effects on Fluid Regulation and Performance
This primary aim of this study was to critically assess whether or not sweat water content and sodium concentration were acutely regulated by dynamic changes in antidiuretic hormone (arginine vasopressin or AVP) acting on the…
- Conditions
- Electrolyte Imbalance, Hyponatremia, Hypernatremia
- Trial name
- NCT02084797
- Testing
- V2R (Vasopressin 2 receptor)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Oakland University
Hyponatremia
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia
- Trial name
- NCT00478192
- Testing
- Conivaptan
- Where
- 26 sites in United States, India
- Volunteers
- 50 people
- Sponsor
- Cumberland Pharmaceuticals
Hyponatremia
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
- Trial name
- NCT01909336
- Testing
- 0.3% Saline in 3.3% dextrose, 0.45% Saline in 5% dextrose, 0.9% Saline in 5% dextrose
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
Hyponatremia
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid…
- Trial name
- NaCrICh (NCT01301274)
- Testing
- hypotonic, isotonic
- Where
- Argentina
- Volunteers
- 66 people
- Sponsor
- Hospital General de Niños Pedro de Elizalde
Hyponatremia, Premature
Early Sodium Intake in Preterm Newborns
Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome.
- Trial name
- NCT04035564
- Testing
- Sodium < 1mEq/kg/day, Sodium 5mEq/kg/day
- Where
- Mexico
- Volunteers
- 52 people
- Sponsor
- Hospital del Niño "Dr. Federico Gomez Santos"
Advanced Cancers
Tolvaptan in Hyponatremic Cancer Patients
The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.
- Trial name
- NCT01199198
- Testing
- Tolvaptan
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- M.D. Anderson Cancer Center
Hyponatremia
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
- Trial name
- INSIGHT (NCT00550459)
- Testing
- Tolvaptan
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia, Acute Decompensated Heart Failure
Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)
This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).
- Trial name
- CONVERT-H (NCT00843986)
- Testing
- conivaptan
- Where
- 4 sites in India
- Volunteers
- 9 people
- Sponsor
- Cumberland Pharmaceuticals
Hyponatremia
Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease.
- Trial name
- NCT00727090
- Testing
- Conivaptan
- Volunteers
- 6 people
- Sponsor
- Northwestern University
Hyponatremia
Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children…
- Trial name
- surgical-Na (NCT01251770)
- Testing
- 0.45% NaCl/dextrose 5%, 0.3% NaCl/dextrose 5%
- Where
- Argentina
- Volunteers
- 78 people
- Sponsor
- Hospital General de Niños Pedro de Elizalde
Syndrome of Inappropriate Antidiuretic Hormone Secretion
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in…
- Trial name
- NCT03048747
- Testing
- Tolvaptan Oral Tablet
- Where
- 6 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.