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Hyponatremia clinical trials

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NCT ID: NCT02352285 Terminated - Clinical trials for Heart Failure With Hyponatremia

Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure

AQUATIC
Start date: December 2012
Phase: Phase 4
Study type: Interventional

The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na levels in patients with worsening heart failure and hyponatremia.

NCT ID: NCT02272725 Completed - Acute Kidney Injury Clinical Trials

Non-steroidal Anti-inflammatory Affect on Kidneys in Endurance Distances

NAKED
Start date: March 2015
Phase: Phase 3
Study type: Interventional

The specific aim of this study is to evaluate the safety of non-steroidal anti-inflammatory drugs (NSAIDs) and their impact on renal function and/or contribution to exercise-associated hyponatremia (EAH) during an ultramarathon foot race. There is currently much debate over whether NSAID ingestion during endurance events contributes to acute kidney injury. Endurance events often ignite a "perfect storm" of physiologic insults- heat stress, dehydration, and myopathy- which can all negatively impact kidney function. There is a concern that NSAIDs may further potentiate these negative effects as well as contribute to EAH through its anti-diuretic affect. To date, no powered, prospective study has ever examined the effects of NSAIDs on either of these two biochemical outcomes Ultramarathon endurance events, defined as any race longer than a marathon (26.2 miles), are increasing in popularity, with a 10% increase in annual participants, and more than 69,000 finishers worldwide in 2013. Considerable literature has documented alterations in serum biochemical profiles of these endurance athletes, with consistent evidence of elevated serum creatinine (Cr) levels in healthy race finishers as well as those seeking medical care. While acute renal failure in ultramarathon runners is a rare occurrence, acute kidney injury is common, ranging from 34% in a single-stage ultramarathon to 55-80% in multi-stage ultramarathons. The evidence is equivocal regarding NSAID ingestion and AKI. One study showed that runners who ingested NSAIDs prior to marathons had greater post-race creatinine levels than matched controls as well as higher rates of hospitalization and acute renal failure. However, this contrasts with several other studies that showed a marked lack of difference in creatinine levels or development of acute kidney injury between NSAID users and non-users during ultramarathons. The only randomized trial to date on this subject found no difference in serum creatinine levels between the NSAID and placebo groups at ultramarathon race end, however conclusions were limited by a small unpowered sample size. Exercise associated hyponatremia (EAH), defined as a serum sodium concentration below 135mEq/L, is recognized as a relatively common issue in endurance running events. The incidence of EAH varies depending upon the distance of the race, with reported values of 3-28% for marathons, 23 - 38% for triathlons and 4-51% in single-stage ultramarathons. EAH is likely under-diagnosed as athletes are often asymptomatic. While EAH most often manifests as non-specific symptoms such as nausea, vomiting, dizziness, and fatigue, it can be a potentially fatal disease that can progress to encephalopathy, seizures, pulmonary edema, and death. There have been no large prospective studies examining the relationship between EAH and NSAID ingestion.

NCT ID: NCT02263586 Completed - Hyponatremia Clinical Trials

Influence of Triathlon on the Electrolyte Balance

Ironman
Start date: August 2014
Phase: N/A
Study type: Observational

Aim of the study is examining the incidence of the occurrence of hyponatremia during a Triathlon

NCT ID: NCT02242604 Completed - Hyponatremia Clinical Trials

Characterization of Neuropsychologic and Physical Performance in Geriatric Patients With Hyponatremia.

Start date: April 2014
Phase:
Study type: Observational

Our purpose is to investigate the improvement of the cognitive, neuropsychologic and physical capabilities using a standardized multidimensional geriatric assessment (MGA) consisting of a battery of validated assays after correction of hyponatremia in patients 70 years or older.

NCT ID: NCT02215148 Terminated - Brain Injury Clinical Trials

Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients

Start date: November 2014
Phase: N/A
Study type: Observational

To assess the pharmacokinetic profile of tolvaptan in critically ill acute brain injury patients and to secondarily evaluate the clinical response and safety of tolvaptan in acute brain injured patients

NCT ID: NCT02103491 Completed - Hyponatremia Clinical Trials

Effects of Oral Salt Supplementation on Physical Performance During a Half-ironman

SALTED
Start date: June 2013
Phase: N/A
Study type: Interventional

Background: Ultradistance athletes frequently consume salt supplements during competitions to compensate the loss of electrolytes by sweating. The aim of this study was to investigate the effectiveness of oral salt supplementation to improve exercise performance during a half-ironman triathlon. Methodology: Twenty-six experienced triathletes were matched for age, anthropometric data and training status and randomly placed into the salt group (113 mmol Na+ and 112 mmol Cl-) or the control group (cellulose). The experimental treatments were provided in unidentifiable capsules and were ingested before and during the race. Participants competed in a real half-ironman triathlon and race time was measured by means of chip timing. Pre and post-race, body mass, maximal force during a whole-body isometric strength test, maximal height during a countermovement jump, and blood samples were obtained. Sweat samples were obtained during the running section.

NCT ID: NCT02020278 Terminated - Hyponatremia Clinical Trials

An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia

Start date: April 22, 2016
Phase: Phase 3
Study type: Interventional

The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and to assess the efficacy of tolvaptan in increasing serum sodium for those participants who received optional continuing tolvaptan treatment of variable duration (up to 6 months).

NCT ID: NCT02012959 Terminated - Hyponatremia Clinical Trials

Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia

Start date: September 22, 2015
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT02012660 Completed - Hyponatremia Clinical Trials

Relationship Between Heat Wave and Hyponatremia

Start date: February 2014
Phase: N/A
Study type: Observational

The objective of this study is to explore the relationship between moderate to severe hyponatremia and heat.

NCT ID: NCT01909336 Completed - Hyponatremia Clinical Trials

Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia

Start date: July 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.