View clinical trials related to Hyperkalemia.
Filter by:In this pilot study, 30 prevalent hemodialysis patients will undergo three regular hemodialysis sessions during which various potassium assessments will be performed. Pre- (t1) and post-dialysis (t2) plasma potassium levels (K+Pl) will be measured using standard ion-selective electrodes. These values will be correlated to K+ determine in saliva probes (K+Sa) using genetically encoded potassium ion indicators (GEPIIs). Additionally, continuous ECG will be recorded during each hemodialysis treatment and potassium assessment (K+ECG) will be performed upon ECG-based parameters and correlated to K+Pl.
Renin-angiotensin-aldosterone system inhibitors (RAASi) have transformed prognosis of patients with heart failure with reduced ejection fraction, diabetic nephropathy and chronic kidney disease. However, in everyday clinical practice patients often receive suboptimal doses of RAASi. The development of hyperkalaemia is one of the reasons for dose reduction or complete withdrawal of RAASi and this in turn is likely to have an adverse impact on patient outcomes. Yet it remains unknown precisely how often hyperkalaemia leads to changes to RAASi doses, if it is the sole reason, or whether this occurs in combination with other clinical situations such as worsened renal function and hypotension. It is also unclear what influences the decision-making process of healthcare professionals in managing patients with hyperkalaemia who take RAASi and if this is influenced by specialty, experience or indications for RAASi. In order to improve our understanding of the problem we are taking forward a research study (made up of 3 complimentary studies). These data are needed to help achieve our ultimate goal of improving the care of patients with prognostic indication for RAASi.
The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic haemodialysis.
This is a descriptive single arm open-label interventional trial lasting 6 weeks aiming to test if a low protein healthy K-rich diet with fruits, vegetables, whole grains, and nuts with concomitant use of new potassium binder (SZC) can be safely prescribed to patients with chronic kidney disease (CKD) stages 4 and 5 with hyperkalemia. Thirty adult CKD patients with hyperkalemia will be included. In the first 3 weeks of the study the plasma K will be normalized with the use of SZC and then the participants will receive a fruit basket during 3 weeks. SZC will be continued thru out the study. Primary end points will be changes in patient satisfaction with treatment, patient symptom list, and intake of energy and protein before and after the stabilization and healthy diet phase. Secondary outcomes will include changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins.
- Participant centres and researchers: 20 National Public Health System hospitals. Cardiology specialist physicians - Clinical Research Ethics Committee (CREC): Hospital 12 de Octubre, Madrid - Main goal: To estimate prevalence and, in medium term basis (12 months), incidence of hyperkalaemia in heart failure (HF) outpatients with reduced ejection fraction (REF) and its relationship with non-optimal HF therapy and clinical outcomes (mortality and hospital admission). - Study design: National multicentric prospective observational study that includes 12 months follow-up of consecutive cases of HF outpatients with REF. Inclusion baseline visit and follow -up visits at 12 months will be scheduled for collecting clinical and blood sample data of patients. - Study population: The expected number of patients recruited in 20 Spanish research centres is 600.
To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.
Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure. Globally, the reported incidence of hyperkalemia varies from 1.1 to 10 per 100 hospitalizations, depending on the patient cohort and comorbidities. Hyperkalemia is a potentially life-threatening electrolyte disturbance that can be fatal if left untreated. Several studies have established the association between hyperkalemia and all-cause mortality. Because of the deleterious cardiac effects of hyperkalemia, its management is an emergency intervention. However, robust evidence is lacking to guide the emergency management of patients with hyperkalemia. Emergency treatment approaches are largely based on small studies, anecdotal experience, and traditionally accepted practice patterns within institutions. Therefore, a rigorous evaluation of the first-line treatments of hyperkalemia in emergency departments is needed and a large scale randomized clinical trial is warranted before robust recommendations for clinical practice can be made. Our clinical trial will improve the safety of patients with acute hyperkalemia and will help clinicians in their day by day practice to choose the treatment that significantly reduces morbidity and mortality during acute hyperkalemia management. Our results will be delivered in a timely fashion, owing to the high prevalence of hyperkalemia in the emergency department setting and to the commitment of the INI-CRCT network of Excellence, along with ED specialists used to work jointly. the primary objective of our trial is to compare insulin/dextrose intravenous infusion, nebulized salbutamol or combination of nebulized salbutamol and insulin/dextrose intravenous infusion to reduce serum potassium concentration at 60 minutes, as first-line treatment, in emergency departments.
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
This study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 mEq/L) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower incidence of cardiac arrhythmias in patients with an ICD. Patients will be randomized to this treatment or a control arm, where patients will receive usual guideline recommended follow-up.
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. Approximately 140 participants will enter CP at approximately 46 sites in locations including but not limited to Europe and North America for this study. Treatment will include 3 phases: the CP, MP, and LTMP. 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. 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. 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.