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Inappropriate ADH Syndrome clinical trials

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NCT ID: NCT04987385 Completed - Clinical trials for Syndrome of Inappropriate Antidiuresis (SIAD)

Effect of Protein Supplementation on Plasma Sodium Levels and Urinary Urea Excretion in Patients With SIAD

TREASURE
Start date: October 8, 2021
Phase: N/A
Study type: Interventional

This study aims to investigate whether a 7-day dietary high protein supplementation of 90 grams per day increases plasma sodium levels in hyponatremic patients with chronic SIAD. Enrolled patients will receive first dietary high protein supplementation for one week. After a wash-out phase of at least one week, the patients will receive oral urea for another week.

NCT ID: NCT04256499 Completed - Hyponatremia Clinical Trials

Water Load Test Value for Hyponatremia

WATERLINE
Start date: January 1, 2001
Phase:
Study type: Observational

Acute water load test has been using to diagnose renal ability to excrete water for decades. Latest recommendations for the diagnosis of hyponatremia do not recommend performing such a test. The investigators aim at, retrospectively, study the value of acute water load test in patients suffering from a syndrome of inappropriate antidiuresis.

NCT ID: NCT04119206 Completed - Hyponatremia Clinical Trials

Tolvaptan Versus Fluid Restriction in SIADH

Start date: January 1, 2009
Phase:
Study type: Observational

Context. The relevance of hyponatremia has been acknowledged by guidelines from the United States of America (2013) and Europe (2014). However, treatment recommendations differ due to limited evidence. Objective. In hyponatremia following pituitary surgery - caused by the syndrome of inappropriate antidiuretic hormone (SIADH) secretion - the investigators compared fluid restriction with the pharmacological increase of water excretion by blocking the vasopressin 2 receptors with tolvaptan at a low and moderate dose. Design. Prospective observational study. Setting. Neurosurgical Department of a University hospital with more 200 pituitary procedures per year. Patients. Participants undergoing surgery for sellar lesions and developing a serum sodium below 135 mmol/L. The diagnosis of SIADH was established by eu- or hypervolemia (daily measurement of body weight and fluid balance daily), an inappropriately concentrated urine (specific gravity) and exclusion of a cortico- and thyreotropic insufficiency. Intervention. Participants were treated with fluid restriction (n=38) or tolvaptan at 3.75 (n=38) or 7.5 mg (n=48) orally. Main Outcome Measures. Treatment efficacy was assessed by the duration of hyponatremia, sodium nadir and length of hospitalization. Safety was established by an increment serum sodium below 10 mmol/L per day and exclusion of side effects.

NCT ID: NCT03924674 Completed - Clinical trials for Fluid and Electrolyte Imbalance

SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients

SOFI
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Intravenous fluids (IVF) are used in hospitalized patients to replenish the fluid and electrolyte losses of patients who cannot take adequate hydration by mouth or through their gut. Inappropriate use of IVF may cause serious problems, including abnormalities in blood electrolytes such as sodium, which can lead to serious but rare neurologic harm; pain and discomfort from multiple IV insertions and subsequent complications (e.g., IV infiltration); and inadequate monitoring for adverse effects. Investigators currently don't know what the most commonly used IVF in hospitalized pediatric patients are, and there are no national benchmark data for IVF use. The American Academy of Pediatrics published a Guideline on maintenance IVF in November 2018, which contains one major recommendation: to use isotonic (having a similar electrolyte concentration to blood plasma) maintenance IVF in medical and surgical patients 28 days to 18 years old without pre-existing serious illnesses. This project aims to better describe and standardize the use of IVF in inpatient pediatric settings across the U.S. and evaluate the impact of an intervention bundle on maintenance IVF use. This project aims to improve health care value by reducing the number of routine laboratory draws. In Quality Improvement research, there are three different types of measures - outcome measures, process measures and balancing measures. In this project, the following will be used as a process measure: The proportion of daily weight measurements for patients on maintenance IVF. The following will be used as balancing measures: 1. There will be no increase in the number of floor-to-PICU transfers during hospitalization from baseline. 2. There will be no increase in the number of serum sodium lab results obtained from baseline. 3. There will be no increase in adverse events prompting a change in clinical management from baseline: hypertension or edema requiring a diuretic, hypertension requiring anti-hypertensive medication, and acute kidney injury (AKI) requiring renal replacement therapy (RRT)/dialysis.

NCT ID: NCT03202667 Completed - Hyponatremia Clinical Trials

Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study

SANDx
Start date: December 15, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia. Especially chronic (>72h) SIADH is difficult to treat as standard therapeutic options (water restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making additional therapy necessary. Empagliflozin is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a well-tolerated treatment option for type 2 diabetes mellitus. The inhibition of SGLT2 in the proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with chronic SIADH, as it resembles the aquaretic effect of urea. The aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium levels of patients with chronic SIADH.

NCT ID: NCT03048747 Completed - Clinical trials for Syndrome of Inappropriate Antidiuretic Hormone Secretion

A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH

Start date: March 2, 2017
Phase: Phase 3
Study type: Interventional

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 patients with hyponatremia in the SIADH.

NCT ID: NCT02874807 Completed - SIADH Clinical Trials

Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study

SAND
Start date: September 5, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia. The therapeutic options, aside from treating the underlying disease, depend upon the onset and severity of the symptoms and involve usually fluid restriction or hypertonic saline infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable number of patients which do not sufficiently respond, making additional therapy necessary. Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in SIADH. The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the serum sodium levels of patients with SIADH.

NCT ID: NCT02729766 Completed - Clinical trials for Inappropriate ADH Syndrome

Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study

DIVE
Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-Inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in the syndrome of inappropriate antidiuretic hormone (ADH) secretion (SIAD). Because patients with SIAD usually have several comorbidities and different medications, studies investigating the physiological effects are difficult to interpret. Therefore a model to study the possible physiological effect of SGLT2-inhibitors in hypotonic hyponatremia as in SIAD is needed. The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on serum sodium levels of healthy volunteers with induced hypotonic hyponatremia.

NCT ID: NCT02573077 Completed - Cancer Clinical Trials

An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy

ASSERT
Start date: October 2015
Phase:
Study type: Observational

This observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed treatment(s) according with the clinical practice regardless of the patient participation in the study. The purpose of this NIS is to collect additional scientific and clinical information that can help in describing the characteristics of cancer patients with hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to keep under control serum [Na+] and the guidelines for the management of this population in Italy.

NCT ID: NCT02548845 Completed - Hyponatremia Clinical Trials

An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain

ALGA
Start date: December 2015
Phase:
Study type: Observational

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. Since it is hypothesised that the adherence to the SEOM algorithm is not 100%, the current retrospective non-interventional study will investigate the perceived and actual adherence of participating centres to the SEOM algorithm and its impact on patient outcomes