Active clinical trials for "Dehydration"

The investigators want to understand the impact of the body losing and gaining water on brain function. Participants will restrict fluids consumed and exercise to lose 5% of body mass. Participants will then be provided fluid equal to the volume lost to consume over 2 hours (recovery). A series of brain function tests will be performed at baseline, following weight loss, and following recovery.

The present study aims to measure the impact of consuming a lower sugar flavored water compared to an equal amount of plain water during exercise on selected rehydration markers in healthy children. Participants will complete two experimental visits designed to examine the differentiating effects of one of two selected beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration markers and related perceptual variables during repeated bouts of exercise in a warm environment to induce mild dehydration.

English Synopsis I. Title of Study: A trial of BUN/Cr-based hydration therapy to reduce stroke-in-evolution and improve short-term functional outcomes for dehydrated patients with acute ischemic stroke-version 2. II. Indication: We use blood urea nitrogen (BUN)/blood creatinine (Cr) ratio≧15 as a dehydration biomarker. This clinical trial aims to determine if more aggressive intravenous fluid supplement instead of present treatment would yield a better outcome in patients with acute ischemic stroke and a BUN/Cr ratio≧15. III. Phase of Development: Phase III, randomized double-blind control trial. IV. Study Rationale: We have recently reported a novel finding that the blood urea nitrogen (BUN)/creatinine (Cr) ratio, a marker of hydration status, was an independent predictor of early neurological deterioration among patients who had suffered acute ischemic stroke. Pilot study was then designed to determine if providing hydration therapy, specifically intravenous saline infusion, to patients with a blood urea nitrogen/creatinine ratio (BUN/Cr) ≥15 improves outcomes after acute ischemic stroke. The results showed that patients with a presenting BUN/Cr ≥ 15 who received saline hydration therapy experienced a better functional outcome compared with similar patients who received standard therapy. V. Study Objectives: Primary objective: To compare the effectiveness of BUN/Cr-based hydration therapy with standard treatment in early neurological improvement (ENI) rate at 72 hours for dehydrated subjects with acute ischemic stroke Secondary objectives: To compare the benefit of BUN/Cr-based hydration therapy with standard treatment after three months using measure of modified Rankin scale (mRS) VI. Study Design: Duration of Treatment: 12 hours Number of Planned Patients: 288 subjects Investigational Product: normal saline Endpoints: Primary endpoint: To compare the ENI rate between group at 72 hours. ENI is defined as the improvement of the NIHSS score by 2 or more points or a score of 1 or 0 at 72 hours after the onset of stroke. Secondary endpoints: To compare the rate of favorable functional outcome at 3 months. Scores <=1 on the mRS are considered to indicate a favorable outcome. Criteria for Evaluation Inclusion criteria: Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist. has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS) the time between the onset of neurological symptoms and starting therapy are less than 24 hours admission BUN/Cr≧15 Exclusion criteria: no informed consent obtained initial NIHSS >10 prepared for or received fibrinolytic therapy prepared for or received surgical intervention with 14 days congestive heart failure according to past history or Framingham criteria history of liver cirrhosis or severe liver dysfunction (ALT or AST > x 3 upper normal limit) admission blood Cr >2 mg/dl initial blood pressure SBP<90 mmHg fever with core temperature >=38°C indication of diuretics for fluid overload any conditions needed more aggressive hydration or blood transfusion cancer under treatment life expectancy or any reasons for follow-up < 3 months Statistical Methods: The primary objective is efficacy using the binary endpoint of ENI. Descriptive statistics on continuous measurements will include means, medians, standard deviations, and ranges, while categorical data will be summarized using frequency counts and percentages. For the primary endpoint of ENI rate, the proportion of subjects with ENI response will be summarized by treatment group. The proportions of ENI will be compared between BUN/Cr-based hydration therapy (Arm A) and Standard therapy (Arm B) using two proportion Z test. The secondary objectives of this study are to evaluate the benefit of BUN/Cr-based hydration therapy after three months using measure of modified Rankin scale. For the secondary endpoint comparisons between groups, independent t-test will be considered. Duration of the Study: 3 years (or From 01/09/2020 to 31/08/2023) End of Study : When total 288 participants are enrolled or meet the criteria of early termination.

Acute decompensated heart failure (ADHF) is a complex clinical syndrome caused by cardiac abnormalities compromising the ability of the heart to provide a blood supply adequate to the metabolic needs of peripheral tissues. ADHF is characterized by systemic and pulmonary fluid retention, with weight gain, peripheral edema, needing diuretic therapy. Moreover, ADHF is associated with neurohormonal hyper-activation with enhanced sympathetic nervous and renin-angiotensin-aldosterone systems stimulation, that sustain the vicious circle of cardiac dysfunction and fluid retention. The administration of high doses of diuretics, usually required in ADHF treatment, can induce hypovolemia-induced neurohormonal activation and transient deterioration of kidney function, that, in turn, counteracts the effect of diuretics and limits recovery from fluid overload. The investigators hypothesized that, in patients with ADHF, a more controlled and physiologically-oriented dehydration may blunt diuretic-associated neurohormonal activation, thus providing a safer and more sustained clinical benefit. This controlled dehydration can be achieved by combining furosemide with the RenalGuard System (see The RenalGuard™ System Operator's Manual for specific instructions in setting up and running the device). To date, no data have been provided regarding the potential beneficial effect of this therapeutic strategy in patients with ADHF and fluid overload. Much of the evidences on the use of the RenalGuard system comes from the clinical setting of acute kidney injury (AKI) prevention in patients undergoing intravascular contrast exposure. In this specific field, furosemide-induced high-volume diuresis with concurrent maintenance of intravascular volume through matched hydration, by the RenalGuard System, is now considered by current Guidelines a recommended strategy for AKI prevention in patients with chronic renal failure undergoing coronary interventional procedures. Based on this experience, the investigators will assess the safety and efficacy of this known system capable of delivering intravenous fluid in an amount exactly pre-determined, considering the volume of urine produced by the patient and precisely weighed by the system. This could prevent hypovolemia that may occur in response to high-volume diuresis induced by furosemide. The researchers will perform a spontaneous, prospective, randomized trial aiming at investigating the effect of combined furosemide-induced diuresis and automated matched dehydration, compared with standard furosemide administration in ADHF patients with fluid overload.

Dehydrated stomatocytosis is a genetic disorder characterized by chronic hemolysis, variable anemia and erythrocyte dehydration. Causative mutations have been identified in either the Gardos (KCNN4) channel or the mechanosensitive channel PIEZO1. Senicapoc is a selective blocker of the Gardos channel that has been extensively studied in sickle cell disease and shown to be safe with limited side-effects. However, senicapoc did not meet the designated clinical endpoints in a pivotal phase 3 trial. The present study is an explanatory, proof-of-concept study of Senicapoc administered once daily in patients with familial dehydrated stomatocytosis caused by autosomal dominant V282 mutations in the Gardos (KCNN4) channel.

Since nitrous oxide/oxygen mixture is effective to reduce pain and anxiety induced by various painful procedures in children, the investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children. The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.

The aim of this study is to evaluate the efficacy of an optimal-massive intervention (OMI) based on increasing shear viscosity of fluids, nutritional support with oral nutritional supplements (ONS) and triple adaptation of food (rheological and textural, caloric and protein and organoleptic) and oral hygiene improvement on the incidence of respiratory infections in older patients with OD. We have designed a randomized clinical trial, with two parallel arms and 6 months follow-up. The study population will be constituted by older patients of 70 years or more with OD hospitalized at Hospital de Mataró by an acute process that will be identified by using the volume-viscosity swallow clinical test. We will consecutively recruit 500 subjects during admission (Geriatrics, Internal medicine, etc.) at the Hospital de Mataró. Patients included will be randomly assigned to one of both interventional groups: a) study intervention: multifactorial intervention based on fluid viscosity adaptation (with a xanthan gum thickener -> Nutilis Clear®), nutritional support with a triple adaptation of food (texture, caloric and protein content, organoleptic) + pre-thickened ONS and evaluation and treatment of oral hygiene (tooth brushing + antiseptic mouthwashes + professional dental cleaning), or b) control intervention: standard clinical practice (fluid adaptation with Nutilis Powder and simple texture adaptation for solids). Main outcome measures: respiratory infection incidence during the 6-month period follow-up. Secondary outcomes: mortality at 6 months, general hospital readmissions and readmissions due to respiratory infections, nutritional status, hydration status, quality of life, functional status, oral hygiene and dysphagia severity and its relationship with other study variables.

This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.

Buoy is an all-natural, organic, FDA compliant dietary electrolyte supplement that can be dissolved in 8-12oz water (or other liquid) and provide electrolytes in servings of 1/3 teaspoon. This study will evaluate Buoy in hydrating active adults.

The central hypothesis is that improving hydration through increased water consumption will change the relative abundance of mucolytic bacteria found in the stool. Therefore the specific aims are 1) to quantify intervention effects on fecal microbiota relative abundance and plasma lipopolysaccharide binding protein, 2) observe the effects of the intervention on bowel frequency and signs/symptoms of gastrointestinal stress, and 3) to investigate relations between executive function and hydration status.