Electrolyte Disorder

The global population of older adults is rapidly growing, with a significant increase in those aged 65 and over, especially in China. Frailty, a condition marked by reduced strength and function across multiple body systems, is common among the elderly and can lead to serious health issues such as falls, disability, hospitalization, and increased mortality. This trial aims to explore the characteristics and influencing factors of frailty in community-dwelling older adults in China, as well as to evaluate how nutritional and combined nutrition-exercise interventions affect frailty progression and management in this population. Participants will be randomly assigned to one of three groups for a 3-month intervention period followed by a 9-month follow-up. The first group receives a multifaceted nutrition intervention including anti-inflammatory dietary plans, personalized nutritional management with daily dietary tracking via WeChat, and biweekly health education sessions for participants and caregivers. The second group receives the same nutrition intervention combined with a structured exercise program conducted three times a week, featuring warm-up, aerobic, resistance strength, and relaxation training overseen by professional coaches. The control group will continue with routine community health management including chronic disease education, counseling, and health examinations. During the study, participants will undergo evaluations at baseline, after the 3-month intervention, and at 3, 6, and 12 months follow-up to assess physical performance using the Short Physical Performance Battery SPPB and frailty scores. Additional measures include assessments of frailty trajectories, nutritional risk, intrinsic capacity, quality of life, cognitive function, sleep quality, serum protein and inflammatory markers, and adverse events. Data will be collected via validated questionnaires, clinical exams, and laboratory tests to understand the sustainability and impact of the interventions over time.

Methanol poisoning is a serious health problem, especially in low- and middle-income countries, where outbreaks can cause severe harm to communities. Diagnosing methanol poisoning is difficult because its symptoms resemble other conditions, and traditional tests require costly laboratory equipment. This research aims to evaluate a new bedside test that uses a single drop of blood to detect formate, a substance only present in methanol poisoning, to improve diagnosis speed and accuracy. The research includes two parts first, an observational study comparing the new point-of-care formate test to standard laboratory tests to check its accuracy. If the new test shows good sensitivity, a second study will follow, which is a feasibility trial where hospitals are randomly assigned to different diagnostic approaches. This trial will investigate whether using the bedside test can lead to faster diagnosis and treatment, reduce unnecessary treatments, and evaluate clinical and cost outcomes. Participants suspected of methanol poisoning or unexplained metabolic acidosis at large hospitals in Bangladesh and India will be involved. During the studies, timing from patient arrival to diagnosis and treatment will be measured, along with clinical outcomes such as death rates and treatment needs. The research will also assess how well hospitals can be recruited for this type of trial and aims to raise awareness about methanol poisoning and improve care practices over the study period ending in 2028.

Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in adults aged 18 years and older with Primary Aldosteronism PA. This Phase III, global study involves approximately 250 participants and aims to reduce seated blood pressure and normalize the Renin Angiotensin Aldosterone System RAAS. Participants may have prior treatment with Mineralocorticoid Receptor Antagonists MRAs or potassium-sparing diuretics. Participants will be randomly assigned to receive either baxdrostat or a matching placebo, both given orally once daily. The dose may be increased after two weeks depending on the participants clinical response and how well they tolerate the medication. The study is conducted across about 90 centers in 12 countries and involves parallel groups. Throughout the study, participants will have their seated systolic blood pressure and RAAS activity measured at week 8 to assess changes from baseline. Additional assessments include monitoring potassium levels, urine aldosterone, and albumin levels up to week 52. Safety and treatment effects will be regularly evaluated during visits. Total participation spans from screening through treatment and follow-up visits as scheduled.

Researchers are evaluating the use of veverimer in adults with moderate-to-severe chronic kidney disease CKD who also have metabolic acidosis. This Phase 3 study aims to assess both the effectiveness and safety of veverimer for treating this condition. The study is sponsored by Renibus Therapeutics, Inc. and involves random assignment of participants to different treatment groups. Participants receive either veverimer or a placebo, both given at a dose of 9 grams twice daily. The study uses a parallel design and is quadruple masked to ensure unbiased results. The primary treatment period lasts up to 168 days, during which participants are monitored closely. The study assesses changes in serum bicarbonate concentration and physical performance, among other health measures. Throughout the study, participants will have blood tests and physical performance assessments, such as the Sit-to-Stand 5 times test. Researchers will track safety by monitoring adverse events and evaluate frailty and muscle mass. Participants are expected to maintain consistent food intake and stable use of other medications during the study. The entire participation period includes screening and follow-up visits to carefully measure treatment effects and safety.

Researchers are evaluating the drug WS016 in adults with hyperkalemia, a condition characterized by elevated potassium levels in the blood. This Phase 3 clinical trial aims to study the effectiveness and safety of WS016 through a two-part design including a corrective phase to quickly reduce potassium levels and a maintenance phase to keep potassium normal. An open-label extension phase is also included to assess longer-term treatment effects. In Part A, participants are first randomized to receive either oral WS016 12g or placebo three times daily for 48 hours during the corrective phase. Those who achieve normal potassium levels are then re-randomized to receive WS016 at doses of 6g, 12g, or 18g, or placebo once daily for 28 days in the maintenance phase. Part B is an open-label extension lasting 11 months, where participants receive WS016 starting at 12g daily, with dose adjustments based on potassium levels. Participants will have regular blood tests to monitor serum potassium and other health measures throughout the study. Researchers will track potassium levels during the maintenance phase and corrective phase to assess drug effects. Safety and tolerability will be monitored, and participants completing or discontinuing the maintenance phase may continue treatment in the extension phase. Overall participation can last up to nearly a year depending on enrollment in Part B.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Patients with advanced kidney failure often face serious issues like high potassium levels, severe acidosis, and very high blood urea nitrogen BUN levels. These patients require aggressive dialysis to manage these problems, but rapid lowering of BUN can cause a dangerous condition called disequilibrium syndrome. This research explores adding urea to the dialysis fluid to prevent this rapid BUN decrease while still addressing potassium and acidosis concerns. The study uses Ure-Na 15 gram tablets to add urea to the dialysis fluid. The amount of urea added is carefully calculated based on the dialysis system and the patients serum urea levels to keep the dialysate urea concentration slightly lower than the patients serum level. This intervention is applied during the first one to three dialysis treatments as needed, and patients who receive this urea-added dialysate are closely monitored. Participants will have their laboratory values, vital signs, and symptoms checked frequently during and after dialysis. Key outcomes measured include the occurrence of disequilibrium syndrome within 24 hours after dialysis, serum potassium and CO2 levels every six hours for 24 hours post-dialysis, and serum BUN levels twice daily for three days. This monitoring ensures the safety and effectiveness of the urea addition approach throughout the study duration.

Cardiovascular diseases are a leading cause of death worldwide, with increasing concerns about metabolic dysfunction and type 2 diabetes. Research suggests that the hormone arginine vasopressin AVP, which regulates body fluid balance, may be linked to diabetes risk when water intake is low. This study aims to explore whether increasing water intake with plain water or non-sugar-sweetened beverages can improve hydration, glucose regulation, and cardiovascular health in normal-weight and obese adults. The study involves two groups of adults classified by body mass index BMI as normal weight or obese. Participants will follow an 8-week crossover design with periods of habitual fluid intake, low, moderate, and adequate fluid intake using either plain water or non-sugar-sweetened beverages. Fluid intake is controlled by providing drinks and smart water bottles that record intake and send reminders. The study includes a washout period and weekly lab visits for assessments. Participants will attend weekly lab visits after fasting for at least 10 hours. Assessments include hydration biomarkers from urine samples, body composition, blood pressure, cognitive tests, resting metabolic rate, endothelial function via ultrasound, and oral glucose tolerance tests with multiple blood draws. Continuous glucose monitoring will occur throughout the intervention. Mood, sleep quality, diet, and physical activity will also be monitored using questionnaires and wearable devices. The studys main outcomes include measures of vascular function and glucose regulation over the 8 weeks.

Researchers are evaluating the AK Guard21 software, an investigational medical device designed to detect moderate to severe hyperkalemia high potassium levels in adults with chronic kidney disease CKD stages III-IV. This observational pilot study aims to assess the diagnostic accuracy of the software in an outpatient setting and its usability and reliability during daily remote monitoring. The study focuses on adults at risk of hyperkalemia, including those on specific kidney-related therapies, by analyzing Lead I ECG data from standard or wearable devices. The study includes two arms Arm 2A involves participants scheduled for routine outpatient potassium blood tests who will have ECGs recorded using three devices 12-lead ECG, Apple Watch, HeartBeam. The softwares diagnostic performance for detecting high potassium is compared to lab results. Arm 2B includes a subset of these participants who agree to use the Apple Watch and study app for daily ECG recordings at home for up to four weeks. Participants also complete weekly surveys and may return for confirmatory lab tests if high potassium is indicated. Participants will have ECGs collected and compared to blood potassium levels to evaluate sensitivity, specificity, and other diagnostic measures. During the remote monitoring phase, researchers will track daily compliance, data completeness, and system reliability, including app performance and user experience through surveys. The study measures include diagnostic accuracy at baseline and usability scores after four weeks. The total participation duration varies with the arm, including up to four weeks of remote monitoring.

Researchers are evaluating sodium zirconium cyclosilicate SZC to treat hyperkalaemia in children under 18 years old. This Phase 3, international, open-label study aims to assess the effectiveness, safety, and tolerability of SZC. The study enrolls about 140 children from multiple countries, starting with age groups 6 to under 12 years and 12 to under 18 years. Later, younger age groups may be included based on data reviews. The goal is to see how well SZC controls potassium levels in children with this condition. The study includes three treatment phases Correction Phase CP, Maintenance Phase MP, and Long-Term Maintenance Phase LTMP. In the CP, participants receive fixed doses of SZC orally three times daily for up to 3 days until potassium levels normalize. Doses are adjusted based on body weight and age groups, with possible dose increases after safety reviews. Those who achieve normal potassium enter the 28-day MP with once daily SZC, where doses can be adjusted to maintain potassium levels. Participants may continue in the LTMP using the same dosing approach with monthly visits. Participants undergo regular monitoring including blood tests, urine tests, and ECGs to assess potassium levels, electrolytes, and heart rhythm. Researchers track safety, tolerability, potassium control, and other biochemical changes throughout the phases. The study lasts about 28 weeks, including treatment and a safety follow-up visit one week after the last dose. Data collected will help evaluate SZCs role in managing hyperkalaemia in children.