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Hyperkalemia clinical trials

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NCT ID: NCT06366230 Not yet recruiting - ESRD Clinical Trials

Adding Urea to the Final Dialysis Fluid

Start date: July 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis.

NCT ID: NCT06365684 Not yet recruiting - Clinical trials for Chronic Kidney Disease

Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4

LIBRAL
Start date: April 29, 2024
Phase: Phase 4
Study type: Interventional

Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease. Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis [1]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD. Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi). Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium > 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed

NCT ID: NCT06256991 Not yet recruiting - Hypertension Clinical Trials

Potassium Correction for RAAS Optimization in Chronic Kidney Disease

PROMISE
Start date: April 2024
Phase: Phase 4
Study type: Interventional

The goal of this placebo-controlled, double-blinded cross-over trial is to test whether patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with chronic kidney disease stage 3b/4. The main questions it aims to answer are: - Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in albuminuria and blood pressure? - Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in blood pressure? The trial contains the following interventions: - Participants will be switched from their ACEi/ARB to a standardised dose of irbesartan (150 mg/d). - During two 12-week study periods, participants will receive either patiromer 8.4 g/d or placebo. The order of study periods is randomized. - At the start of each study period irbesartan will be up-titrated to 300 mg/d. - After 1 and 6 weeks, at both periods, plasma potassium will be measured and the irbesartan dose will be reduced to 150 mg/d in case plasma potassium exceeds 5.0 mmol/L. - At 12 weeks from the start of the study period, the endpoints will be assessed. - Between the two study periods, there is a 6-week washout. Irbesartan dose during the wash-out period will be 150mg/d. After washout, participants will switch from the patiromer arm to the placebo arm or vice versa.

NCT ID: NCT06120608 Not yet recruiting - Clinical trials for Hyperkalemia, Diminished Renal Excretion

Evidence for Potassium Restriction in Hemodialysis

EvoKe-HD
Start date: April 22, 2024
Phase: N/A
Study type: Interventional

EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia. Contrary to the traditional recommendations limiting the intake of high-potassium whole foods, such as fruits and vegetables, the investigators propose to switch the focus to foods containing potassium that is readily absorbed by the body (high bioavailability), such as potassium from additives, processed meats, milk, fruit juices and sugary drinks.

NCT ID: NCT05589441 Not yet recruiting - Clinical trials for Liver Transplantation

Nebulized Salbutamol Facilitate Management of Hyperkalemia Postreperfusion During Liver Transplantation

Start date: October 28, 2022
Phase: N/A
Study type: Interventional

The therapeutic effect of nebulized salbutamol on hyperkalemia during reperfusion in liver transplantation patients. Secondary research objectives: To observe the results of blood gas analysis, changes in urinary potassium and hemodynamic parameters, and the incidence of reperfusion syndrome in liver transplantation, and to observe the incidence of postoperative pulmonary complications during the 7-day follow-up. To explore the effect of aerosol inhalation of salbutamol on new liver reperfusion syndrome in patients with liver transplantation, and to provide a theoretical basis for clinical treatment.

NCT ID: NCT04727840 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial)

Start date: March 15, 2021
Phase: Phase 1
Study type: Interventional

This study hypothesizes that the administration of Sodium zirconium cyclosilicate in CKD patients with hyperkalemia while avoiding dietary potassium restriction will normalize their serum potassium levels. Additionally, we aim to assess the effects of a high potassium diet on renal function, endothelial function, acidosis, systemic inflammatory status and gut microbiota.