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Hyponatremia clinical trials

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NCT ID: NCT02545101 Completed - Hyponatremia Clinical Trials

An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH

SAMPLE
Start date: November 2015
Phase: N/A
Study type: Observational

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 antidiuretic hormone (SIADH) secretion.

NCT ID: NCT02449044 Completed - Hyponatremia Clinical Trials

International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia

Start date: May 2004
Phase: Phase 3
Study type: Interventional

This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states.

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: 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: 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.

NCT ID: NCT01879774 Completed - Hyponatremia Clinical Trials

Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

Start date: June 2012
Phase: N/A
Study type: Interventional

The aim of this epidemiological study is to characterize the neuropsychological and motoric performance in patients with hyponatremia. Newer studies revealed an association between mild hyponatremia and unstable walking, frequency of falls and risk of a fracture, questioning the paradigm of an "asymptomatic" hyponatremia. Until now, there is no known detailed investigation and characterisation of the cognitive and motoric performance or limitation by this disorder. Therefore this study will investigate patients with hyponatremia on the basis of neuropsychological and neurological tests.

NCT ID: NCT01850940 Completed - Liver Cirrhosis Clinical Trials

Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia

OASIS
Start date: January 2013
Phase: Phase 3
Study type: Observational

This is a phase IV, open-label, prospective cohort study for 7 days.The recommended starting dose of tolvaptan is 15 mg daily orally. The dose may be titrated on the next day at 15 mg intervals up to 60 mg daily according to the serum sodium level response.Serum sodium level, change in sodium level from baseline, quality of life (EQ-5D-3L), change in body weight, edema, renal function, mortality and liver-related complications on day 7 and day 30 to evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia.