Hyperkalemia

Eligible participants with hyperkalemia will first be randomized in a 5:1 ratio to receive oral WS016 (12g) or placebo three times daily, for a total of six doses over 48 hours. After the 48-hour corrective treatment, participants whose serum potassium is within the normal range will be re-randomized in a 1:1:1:1 ratio to receive oral WS016 (6g, 12g, or 18g) or placebo once daily for 28 consecutive days. Participants who complete the 28-day maintenance phase or prematurely discontinue from it due to hyperkalemia or hypokalemia, and who meet the eligibility criteria, will be eligible to enter Part B. In Part B, participants will receive WS016 for 11 months, starting at 12g once daily, with subsequent dose adjustments based on serum potassium levels.

Acutelines is a prospective biobank including patients with a broad spectrum of acute conditions. Its aim is to facilitate interdisciplinary research on the etiology and development of acute diseases with the aid of systematically collected biomaterials and medical data over various timepoints, both during the course of the patient's disease and after recovery. Clinical data, imaging data and biomaterial (i.e. blood, urine, feces, hair) are collected for patients presenting to the Emergency Department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy), is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure in place and the software used ensures automated capturing of all bed-side monitoring data (i.e. electrophysiological waveforms, vital parameters), and the secure importation of data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration, health insurance companies and pharmacy. Follow up data are collected for all included patients during the first 72-hours of their hospitalization and 3-months, 1-year, 2-years and 5 years after their ED visit. Data and materials to be collected includes: * Demographic and health data (i.e. \[experiences\] health, quality of life, functional status) * Medical history (i.e. co-morbidity, intoxications, medication use) * Admission reason to emergency department * Physical examination and vital parameters * Clinical diagnostic data (i.e. \[point-of-care\] ultrasound, X-ray, CT-scan, laboratory results) * Electrophysiological waveforms (i.e. electrocardiogram \[ECG\], plethysmography) * Biomaterials * Treatment (i.e. medication use, non-pharmacological treatment, treatment decisions, length-of-stay in hospital, admission to intensive care unit \[ICU\])

Ure-Na 15 gram tablets would be used to add to the dialysis fluid How much urea to add would be a simple calculation based on the 45X dialysis system and the patients serum urea concentration. The dialysate fluid urea concentration would be made to be about 15-40 mg/dL lower than the serum concentration. The patients labs/vitals and symptoms would be closely monitored throughout the dialysis treatment.

The AK+ Guard™ application is an investigational Software as a Medical Device (SaMD) developed by AccurKardia, Inc. (New York, USA). It is designed to aid in the diagnosis of moderate to severe hyperkalemia (serum potassium ≥ 6.5 mmol/L) in adults using artificial intelligence analysis of Lead I electrocardiogram (ECG) data. The software is intended as a clinical decision support tool for adults at risk of hyperkalemia, including but not limited to those with end-stage renal disease (ESRD), chronic kidney disease (CKD) on renin-angiotensin-aldosterone system inhibitors, heart failure, adrenal disorders, and patients taking aldosterone synthase inhibitors. The AK+ Guard™ application analyzes only Lead I ECG signals, which may be obtained from standard 12-lead ECGs, clinical-grade ECG devices with Lead I capability, or consumer wearable devices (e.g., Apple Watch). This pilot study is designed to generate preliminary real-world evidence on both the diagnostic performance of the application and its usability in daily life. The study includes two arms: Arm 2A - Outpatient Diagnostic Accuracy: * Estimate sensitivity, specificity, PPV, and NPV of AK+ Guard™ in ambulatory CKD stages III-IV * Evaluate interoperability across selected Lead I ECG capture devices (Apple Watch, HeartBeam, and 12 lead reference) * Characterize system reliability metrics (upload success, algorithm runtime) in the outpatient setting Arm 2B - Remote Patient Monitoring * Quantify participant compliance, data completeness, and attrition during four week remote monitoring * Evaluate user experience using System Usability Scale (SUS) score, Net Promoter Score (NPS), and semi structured feedback * Capture technical performance metrics in a real world, unsupervised context

Protocol title: An open-label study to assess safety and efficacy of SZC in paediatric patients with hyperkalaemia Rationale: Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children \<18 years of age Primary Objective: Correction phase (CP) primary objective: 1. To evaluate the ability to achieve normokalaemia during the CP when initiating treatment with SZC of different dose levels (DLs) in children with hyperkalaemia 28-day Maintenance Phase (MP) primary objective: 2. To evaluate the ability to maintain normokalaemia during the MP when continuing SZC treatment in children achieving normokalaemia Secondary Objectives: All phases secondary objective: 3. To evaluate the change in S-K+ in children treated with SZC MP secondary objectives: 4. To evaluate change in serum aldosterone levels in children treated with SZC during the MP 5. To evaluate change in serum electrolytes (including bicarbonate), spot urinary pH and urinary electrolytes levels in children treated with SZC during the MP Long-term MP (LTMP) secondary objectives: 6. To evaluate the ability of maintaining normokalaemia in children treated with SZC during the LTMP Safety Objective: 7. To evaluate the safety and tolerability of SZC in the 3 phases (CP, MP, and LTMP) Tertiary/Exploratory: 8. To evaluate the acceptability and palatability of SZC through the study Overall design: This is a Phase 3, international, multi-centre, open-label study assessing different doses of SZC. The population to be studied is hyperkalaemic children \< 18 years. Dosing will mirror the regimen approved for adults using body weight equivalent doses. Enrolment will start in 2 cohorts, ages 6 to \< 12 years and 12 to \< 18 years. After review of accumulated data, the independent Data Monitoring Committee (iDMC) will recommend whether to open enrolment in the ages 2 to \< 6 years cohort and later in the ages 0 to \< 2 years cohort. The study will be conducted in approximately 11 countries and 46 sites. All eligible participants with hyperkalaemia will enter an open-label Correction Phase (CP) receiving a fixed dose of SZC three times daily (TID) for up to 3 days until normokalaemia is achieved. Within each age cohorts 2 to \< 18 years, initial participants will be allocated to the dose level (DL) based on body weight equivalent to an adult 5 g TID. After recommendation of higher DLs by the iDMC, subsequent participants may be allocated in the CP to on body weight equivalent to an adult 10 g TID and then potentially on body weight equivalent to an adult 15 g TID. All participants in the ages 0 to \< 2 years cohort will be assigned to the same DL which will be decided based on data from older age cohorts. Participants who successfully achieve normokalaemia in the CP will enter a 28-day open-label Maintenance Phase (MP), which will be initiated with once daily administration of the dose received TID in the CP. During MP, the Investigator is able to titrate the dose up or down in the range 2.5 g to 15 g body weight equivalent to maintain normokalaemia. The MP is followed by the option for participants to continue the study in a long-term maintenance phase (LTMP) where the same titration regimen is used as in MP, but with monthly visits. Study period: Estimated date of first participant enter the CP Q4 2018. Estimated date of last participant completed 27 December 2024. Number of participants: This study aims to enter into CP a total of approximately 140 participants with hyperkalaemia. Of these, approximately 85 participants are expected to have moderate to severe hyperkalaemia. Enrolment will continue until at least 54 participants with moderate to severe hyperkalaemia have entered the MP and 45 participants with moderate to severe hyperkalaemia have completed the MP. A maximum of 55 participants with mild hyperkalaemia will enter the CP. In addition, there are minimum requirements for participants in each age cohort Duration: Study duration is approximately 28 weeks including up to 3 days of correction treatment, followed by maintenance treatment for 28 days, a LTMP for up to 22 weeks, and a safety follow-up visit 1 week after the last dose. Treatments and treatment duration: Treatment will include 3 phases: the CP, MP, and LTMP. All age cohorts are eligible to participate in all phases of the study. The 3 treatment phases are specified below: Correction phase (CP): All eligible participants with hyperkalaemia will enter an open-label Correction Phase (CP) receiving a fixed dose of SZC three times daily (TID) for up to 3 days until normokalaemia is achieved. Within each age cohorts 2 to \< 18 years, initial participants will be allocated to the dose level (DL) 5 g TID. After recommendation of higher DLs by the iDMC, subsequent participants may be allocated in the CP to 10 g TID and then potentially 15 g TID. All participants in the ages 0 to \< 2 years cohort will be assigned to the same DL which will be decided based on data from older age cohorts. Maintenance phase (MP): Participants who successfully achieve normokalaemia in the CP will enter a 28-day open-label Maintenance Phase (MP), which will be initiated with once daily administration of the dose received TID in the CP. During MP, the Investigator is able to titrate the dose up or down in the range 2.5 g to 15 g body weight equivalent to maintain normokalaemia. Long term Maintenance Phase (LTMP): For participants who, at the end of MP, are normokalaemic or hyperkalaemic without being on maximum dose, the MP is followed by the option to continue the study in a long term maintenance phase (LTMP) where the same titration regimen is used as in MP. Data Monitoring Committee: The iDMC will recommend on the opening of dose levels during the CP after reviewing all available data. Additionally, iDMC will recommend whether and when enrolment in the ages 0 to \< 6 years cohorts will begin, and will also evaluate emerging safety data during all phases of the study. Statistical methods: Objectives will be evaluated based on analysis populations corresponding to each study phase. Analysis sets are defined for each phase as the set of all participants who transitioned from previous phase and who received at least one dose of SZC during the phase. Primary assessments of the primary objectives, the probability to achieve and maintain normokalaemia when treated with SZC, will be based on point estimates together with 95% confidence intervals (CIs) from generalised linear models (repeated measures model for the MP). The secondary objective of change in S-K+ over time will be evaluated using a repeated measures linear model. Additional analyses, including analyses for other secondary objectives, will be done descriptively. In general, data will be analysed in the total analysis population, within each age cohort and, for the CP, within adult body weight equivalent dose-level, as appropriate. An interim read-out may be conducted.

In this study, the ECG and echocardiography (ECHO) findings in patients with chronic kidney failure who present to the Etlik City Hospital Emergency Medicine Department will be recorded and compared with literature. Echocardiography is a rapid, reliable, and non-invasive examination widely used by physicians for the monitoring of critically ill patients in emergency departments and intensive care units worldwide. For patients with known chronic kidney failure brought to the emergency department, a blood sample (blood gas and/or biochemistry) will be taken for potassium measurement. Subsequently, an ECG, which is a quick and non-invasive test, will be performed, followed by an ECHO, also a quick and non-invasive test, conducted by an experienced physician. The physician performing the ECHO will not be involved in the treatment process. ECG and ECHO findings will be recorded and compared before and after treatment. Patient mortality will be monitored at 24 hours, 7 days, and 30 days, and other causes of mortality will be excluded. The relationship between ECG and ECHO findings and mortality will be statistically investigated. Based on the premise that hyperkalemia can cause cardiac arrest during diastole, it is hypothesized that there may be right ventricular enlargement in patients with ECG findings indicative of hyperkalemia. In animal studies, echocardiography results during resuscitation have shown right ventricular enlargement in animals with hyperkalemia. Based on this information, we believe that echocardiography findings in hyperkalemic patients may be associated with mortality, and that the combined use of echocardiography and ECG may be effective in predicting mortality

The kidney is a primary site of potassium regulation in the body. Hyperkalemia, elevated serum potassium, occurs in approximately 10% of patients with chronic kidney disease (CKD) and is associated with elevated all-cause mortality. To minimize the risk of hyperkalemia, individuals with CKD are told to restrict dietary potassium. This recommendation is based on very-low quality evidence. Dietary potassium restrictions can negatively impact quality of life, and may put participants at risk of nutritional deficiencies so they should be based on good quality evidence. There is a need for high quality randomized controlled trials investigating the impact of dietary potassium modification on serum potassium concentrations in people with CKD. This trial will evaluate the impact and safety of dietary potassium liberalization using fruit and vegetables on serum potassium concentrations in people with CKD. In this 16-week study, the investigators will test if changing the amount of potassium people with CKD are eating with fruits and vegetables changes the amount of potassium in their blood. The investigators will do this by providing people with fruits and vegetables that are either high or low in potassium for a period of 6 weeks. Then these same participants will be provided with fruits and vegetables that they didn't receive in the first 6 weeks, for an additional 6 weeks in what is called a randomized crossover design. In a randomized crossover design everyone gets both treatments, but the order they get them in is chosen at random, like a coin toss. Thirty participants will be recruited to this study. The investigators will measure blood potassium during the study and see if it changes due to the change in potassium in the fruit and vegetables provided. The investigators think that changing the amount of potassium that participants eat through fruit and vegetables will not lead to a different level of potassium in the participants blood, and that having higher potassium fruit and vegetables in the diet may lead to an increase in the participants quality of life. This study's results could change the dietary recommendation given to people living CKD and potentially allow them to eat a greater variety of food.

This is a multi-center, prospective, single-arm interventional study to evaluate the impact on the implementation of standardized hyperkalemia management in CKD patients. Essentially, this is a quality improvement study to determine whether quality improvement intervention can improve medical care process and clinical outcomes. The intervention of this study is standard hyperkalemia management implementation. Intervention methods include standard disease management and quality audit. * Key contents of HK disease management will be standard clinical pathway for management of HK disease based on GDMT (including sK+ \> 5.0mmol/L as diagnose criteria; HK long term management; RAASi targeted dose treatment and sK+ test at least once/ 3 months and high-risk patients# once/month). Also track sK+ test frequency and RAASi optimization. Quality audit results as feedback for additional medical education. Medical trainings act as ways to educate HK disease management on both HCPs and patients' level. Education for HCPs include GDMT training\*5 times at both study level and individual site level, added at individual site level if quality audit off target (added ≤ 1 time/site quarterly during 0-48 weeks after the first patient enrolled at this site, totally added ≤ 6 times/site). Education for patients include onsite training\*6 times during 0-96 weeks and patient self-learning. (# High risk HK patients: CKD with DKD; CKD with HF; CKD with RAASi initiation or up titration.) * Quality audit includes tracking HCP's perception and action of standardized HK management (quarterly from the first patient enrolled at this site) and patient's adherence to medication and sK+ monitoring (remote visit every 4 weeks \[Q4W\] and review patient daily checklist every 12 weeks \[Q12W\]). * Patient enrolment will begin after the comprehensive GDMT training (both study level and individual site level) for HCPs. Approximately 1,000 adult Chinese patients with renal insufficiency and hyperkalemia will be enrolled from around 50 sites in China. Enrolled patients will be provided with treatment choice and HK management plan determined by HCPs, such as disease education, self management materials, prescription of RAASi use, sK+ test or potassium lowering therapy, etc. * The follow-up duration will be up to 96 weeks. There will be 6 onsite visits for each patient after baseline visit and data collection, arranged on week 12, week 24, week 36, week 48, week 72 and week 96 after enrolment. Patients who withdraw/discontinue early from the study will have an "early withdrawl" visit. * There will be remote visit for patients every 4 weeks if no onsite visit after enrolment.

InSaKa trial is a therapeutic, controlled, open label, with parallel groups of treatment in a 1:1:1 ratio, multi-centre, national and randomized clinical trial to compare insulin/dextrose intravenous infusion, nebulized salbutamol or combination of salbutamol and insulin/dextrose to reduce serum potassium levels at 60 minutes. Eligible patients will be recruited in the emergency department and included in the study after testing for inclusion and non-inclusion criteria. Patients will be eligible for the randomization if they had a serum potassium concentration superior or equal to 6 mmol per liter. Randomization, which will be performed centrally, will be stratified 1) according to the serum potassium level at baseline of the initial treatment phase (6 to \< 6.5 mmol per liter \[moderate hyperkalemia\] AND superior or equal to 6.5 mmol per liter \[severe hyperkalemia\]), and 2) according to the prescription or not of intravenous diuretics during the 6 previous hours. The protocol will be approved by the ethical committee (random allocation) of the IRB. All patients will provide written informed consent and the study will be performed in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice. All electrocardiograms will be read at a core electrocardiographic laboratory. At the time of screening, patients who meet all the inclusion and do not have non-inclusion criteria will be assigned to one of the 3 groups of treatment. The serum potassium will be then measured at 60 minutes. If the patient still has hyperkalemia at 60 minutes, the patient will be re-administered a treatment, left at the discretion of the physician in charge. This treatment might include insulin/dextrose intravenous infusion, nebulized salbutamol, the combination of nebulized salbutamol and insulin/dextrose intravenous infusion, bicarbonate, diuretics or dialysis. Especially, bicarbonate should be prescribed in case of metabolic acidosis or hypovolemic shock, and diuretics in case of acute heart failure. Importantly, if the patient has a major cardiovascular event before 60 minutes, all these treatments might be prescribed at the discretion of the physician in charge, if the clinical situation requires one or more of these therapeutic options, and based on up-to-date clinical practice guidelines and recommendations. Serum potassium levels will be measured at local laboratories at baseline and 60, 180 minutes and 24 hours. They will perform a visual inspection and a validated semi-quantitative test on each blood sample as an assessment for hemolysis. An independent adjudication committee will adjudicate all major cardiovascular events. The trial will be monitored by a Data Safety Monitoring Board.

Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. According to the suggestions from 2018 Ministry of Health and Welfare in Taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. In our own data, the average daily vegetables intake was only 2.1 servings among patients with CKD stages 3 to 5 not yet on dialysis. Therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with CKD stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.