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Dehydration clinical trials

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NCT ID: NCT05285371 Active, not recruiting - Fluid Therapy Clinical Trials

Boluses of Ringer's in Surgical Kids (BRiSK Study)

BRiSK
Start date: February 22, 2022
Phase: Early Phase 1
Study type: Interventional

Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar. The basic tenets include: (1) Continuous intravenous fluid administration; (2) Total fluid volume based on the "4:2:1" rule; (3) Use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (NaCl) + 20 milliequivalents per liter (mEq/L) potassium chloride (KCl); and (4) Inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.

NCT ID: NCT05174793 Completed - Dehydration Clinical Trials

Using Urine Color as a Marker of Hydration Status

Start date: March 15, 2020
Phase: N/A
Study type: Interventional

The purpose of this study was to determine if rapid changes in hydration status could be determined by urine color expressed in CIE color space

NCT ID: NCT05129358 Completed - Dehydration Clinical Trials

Testing of an Electronic Patch During Mild Dehydration

Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.

NCT ID: NCT05121389 Recruiting - Ischemic Stroke Clinical Trials

BUN/Cr-based Hydration Therapy to Improve Outcome of Patients With Acute Ischemic Stroke

Start date: January 7, 2021
Phase: Phase 3
Study type: Interventional

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: 1. 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. 2. 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: 1. Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist. 2. has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS) 3. the time between the onset of neurological symptoms and starting therapy are less than 24 hours 4. admission BUN/Cr≧15 Exclusion criteria: 1. no informed consent obtained 2. initial NIHSS >10 3. prepared for or received fibrinolytic therapy 4. prepared for or received surgical intervention with 14 days 5. congestive heart failure according to past history or Framingham criteria 6. history of liver cirrhosis or severe liver dysfunction (ALT or AST > x 3 upper normal limit) 7. admission blood Cr >2 mg/dl 8. initial blood pressure SBP<90 mmHg 9. fever with core temperature >=38°C 10. indication of diuretics for fluid overload 11. any conditions needed more aggressive hydration or blood transfusion 12. cancer under treatment 13. 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.

NCT ID: NCT05111392 Completed - Dehydration Clinical Trials

Hydration Dynamics and Influence of Beverage Composition

Start date: September 3, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The study examines interactions between fluid availability in the gut and fluid retention in the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. Healthy, euhydrated adults will be studied. The results will help establish formulations of beverages that sustain if not promote acute euhydration.

NCT ID: NCT05092854 Completed - Heat Stress Clinical Trials

The Effect of AMP Human Sodium Bicarbonate Lotion on Dehydrated Heat Stress

AMP2
Start date: September 3, 2021
Phase: N/A
Study type: Interventional

The primary purpose of the proposed study is to evaluate the effects of a topical sodium bicarbonate lotion (PR Lotion, AMP Human, Park City, UT) on measures of hydration status and fluid balance in humans when exposed to the heat while resting and during light/moderate aerobic exercise. A secondary purpose is to examine these same effects with two differing dosage patterns of the lotion. A tertiary purpose is to investigate the effect of an amino acid rehydration beverage in comparison to a placebo on measurements of hydration, subjective assessments of stress, and vestibular as well as musculoskeletal measures of fatigue for up to 24-hours after the completion of both passive and exertional heat stress within a dehydrated state.

NCT ID: NCT05033665 Completed - Mood Clinical Trials

The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men

WEXMO
Start date: May 26, 2021
Phase: N/A
Study type: Interventional

Dehydration is defined as the state of water deficit due to excessive water losses and/or small water intake. Underhydration is the result of inadequate water intake leading to activation of water hormonal homeostasis, characterized by elevated vasopressin, lower urinary output, and concentrated urine without any measurable changes in total body water. It is well established that dehydration (water deficit) decreases exercise performance and worsens mood, mainly in women. However, the impact of increased water intake in underhydrated individuals on their exercise capacity and mood is not known. The aim of the proposed study is to investigate the impact of increased water intake in underhydrated individuals on aerobic exercise performance and mood in both women and men.

NCT ID: NCT04997031 Completed - Dehydration Clinical Trials

Tap Water Intake and Perceptions in US Latinx Adults

TWIPLA
Start date: September 1, 2021
Phase:
Study type: Observational

The purpose of this exploratory cross-sectional investigation is to evaluate associations between tap water perceptions, water consumption behaviors, and hydration status in Latinx adults (18 - 65 y). The objective is to identify perceptual determinants that explain the associations between tap water avoidance and plain water intake and hydration status in Latinx adults. Aim 1: Characterize the degree to which individual- and community-level factors uniquely predict the perception that tap water is not safe in Latinx adults. Aim 2: Evaluate household income, education level, and US nativity as potential moderators of the associations between predictors and perceptions of tap water safety. Aim 3: Evaluate the influence of tap water safety perceptions on plain water intake and 24-h hydration status, after adjustment for predictors of tap water safety perceptions, in a sub-sample of Latinx adults.

NCT ID: NCT04874584 Completed - Quality of Life Clinical Trials

Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Start date: October 27, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to see whether or not a telephone/ text message intervention, delivered by a registered nurse, is helpful in managing symptoms and can also prevent dehydration caused by chemotherapy treatment when given together for patients with metastatic breast, colon, lung or prostate cancer.

NCT ID: NCT04781361 Completed - Fluid Therapy Clinical Trials

Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study

NEOFLUID
Start date: December 30, 2020
Phase:
Study type: Observational

Considering the physiological changes in fluid and electrolyte balance and providing proper support are one of the important aspects of neonatal intensive care. Maintenance intravenous fluids are designed to maintain homeostasis when a patient is unable to uptake required water, electrolytes, and energy. Hypotonic fluids are still the most commonly prescribed IV fluids for pediatric hospitalized patients. However, previous studies, including children older than one month of age revealed that traditionally used hypotonic fluids may lead to hyponatremia. Because of the absence of evidence-based data, there is currently no clear consensus on the optimal composition of maintenance intravenous fluid therapy in newborns, leading to wide practice variation. The National Clinical Guideline Center (NICE) 2015 recommends the use of isotonic fluids in term newborn infants and some newborn centers has begun to use isotonic fluids since guidelines recommendations. Since the publication of the NICE guideline, no studies have addressed this topic. In this prospective, observational , multicentric study, conventional hypotonic fluids containing sodium chloride (NaCl) < 130 mmol/L compared with isotonic fluids (containing NaCl between 131-154 mmol/L) in terms of the risk of hyponatremia, hypernatremia, plasma sodium (pNa) level change, treatment morbidities, hospitalization duration and mortality.