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, multicenter, randomized, double-blind, placebo-controlled study aims to assess how baxdrostat affects seated blood pressure and the normalization of the Renin Angiotensin Aldosterone System (RAAS). The trial includes participants with or without prior treatment using Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Participants will receive either baxdrostat or a matching placebo tablet taken orally once daily. The dose may be increased after two weeks depending on how the participant responds and tolerates the treatment. The study is planned to take place globally across about 90 centers in 12 countries. Treatments will be compared over the course of the study to evaluate their effects on blood pressure and RAAS normalization. During the study, participants will have regular assessments including measurements of seated systolic blood pressure and monitoring of RAAS system function at week 8 and week 52. Blood potassium and aldosterone levels will also be tracked. Safety and tolerability will be monitored throughout the study. The total participation period includes initial treatment and follow-up assessments to observe changes and any side effects over time.

Researchers are evaluating veverimer for adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis in this 26-week study. The main goal is to assess whether veverimer can safely improve serum bicarbonate levels and physical performance in this population. This Phase 3 trial is led by Renibus Therapeutics, Inc. and uses a randomized, double-blind design to compare veverimer with placebo. Participants are randomly assigned to receive either 9 grams of veverimer twice daily or a matching placebo for 26 weeks. The study includes detailed monitoring of physical function using tests like the Sit-to-Stand 5 times test and the 6-minute walk test. Additional assessments include quality of life surveys, patient global impressions, and cardiopulmonary exercise testing. Safety is closely monitored through recording adverse events during the study period. During the trial, participants will have regular visits from screening through Day 168 to measure changes in serum bicarbonate and physical performance. They will undergo various tests including blood tests, exercise tests, and questionnaires to evaluate kidney function and quality of life. Researchers will also track safety by noting any side effects or health changes. The total participation time is 26 weeks, with assessments scheduled throughout to capture treatment effects and tolerability.

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 patient's serum urea levels to keep the dialysate urea concentration slightly lower than the patient's 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 study's 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 software's 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 studying sodium zirconium cyclosilicate (SZC) to evaluate its safety, effectiveness, and tolerability for treating hyperkalaemia in children under 18 years old. This phase 3, international, open-label study will enroll about 140 children in multiple age groups, starting with those aged 6 to under 12 years and 12 to under 18 years, with plans to include younger children based on safety data. The study aims to see how well SZC can correct and maintain normal potassium levels in children with this condition. Treatment includes three phases: a Correction Phase (CP), a Maintenance Phase (MP), and a Long-Term Maintenance Phase (LTMP). In the CP, participants receive a fixed oral dose of SZC three times daily for up to 3 days until potassium levels normalize. Doses are adjusted by body weight and may increase based on safety monitoring. Those who achieve normal potassium enter the MP, receiving daily SZC for 28 days with dose adjustments as needed. Participants may continue into the LTMP for ongoing treatment and monthly visits if they meet certain criteria. Participants will have regular assessments including blood tests for potassium and other electrolytes, urine tests, ECG monitoring, and evaluation of safety and tolerability throughout all study phases. Researchers will track potassium levels to assess correction and maintenance, as well as measure related hormones and kidney function markers. The total study duration is about 28 weeks, including a 1-week safety follow-up after the last dose. The study is conducted at approximately 46 sites across several countries.