Clinical Potassium Pilot Study
- Conditions
- Hyperkalemia
- Interventions
- Device: GEPIIDevice: Ion-selective electrodes
- Registration Number
- NCT04251468
- Lead Sponsor
- Medical University of Graz
- Brief Summary
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.
- Detailed Description
Cardiovascular diseases are among the leading causes of death in industrialized countries. Medical therapy for these diseases has seen significant progress, much of which is based on agents interfering with the renin-angiotensin-aldosterone system (angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, mineralocorticoid receptor antagonists, neprilysin inhibitors). However, these agents bear the side effect of reducing renal potassium (K+) excretion and may thus lead to elevation of blood K+ Levels (hyperkalemia). Hyperkalemia is a potentially life-threatening condition, which in its most severe forms requires immediate medical attention, since there is imminent danger of dangerous arrhythmias and sudden cardiac death. Therefore, hyperkalemia is a leading reason to withdraw potentially lifesaving therapy in a significant number of patients, which is considered to have a negative impact on patient outcomes. Recently, novel intestinal potassium binders have been shown to be efficient in reducing incidence and severity of hyperkalemia These compounds have very recently been shown to allow extending the benefits of antihypertensive therapy with spironolactone to patients with chronic kidney disease with refractory hypertension . Yet due to preanalytical problems as well as time and cost-restraints, out-patient monitoring of serum or plasma potassium levels has proven problematic.
The plasma potassium level and kinetics at two timepoints before and after a hemodialysis session as determined by either standard of care (i.e. ion selective electrode) will be compared to the potassium level measured in (i) saliva (salivary potassium \[K+Sa\]) or (ii) determined based on electrocardiogram (K+ECG). Patients suffering from end-stage renal disease undergoing hemodialysis (HD) frequently present with severe hyperkalemia prior to a HD session. During HD treatment, K+ levels undergo unphysiologically rapid changes due to K+ removal via HD as well as due to changes in acid-base status. Thus, HD patients represent a unique population in whom significant K+ derangements and rapid K+ Level changes predictably occur and where these phenomena can be investigated in a safe environment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 18 to 90 years of age
- End stage-renal disease or acute kidney injury patient undergoing hemodialysis
- Ability to provide oral and written informed consent
- Ability and willingness to comply with study procedures
- Willingness to not consume foods or drinks other than water during dialysis session
- Intraventricular conduction abnormalities (left- or right bundle branch block, trifascicular block) which interfere with K+ECG determination
- Active inflammation or infection of the oral mucous membranes or dentition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GEPII Ion-selective electrodes All patients who completed the study. GEPII GEPII All patients who completed the study.
- Primary Outcome Measures
Name Time Method ECG QRS duration Pre- (t1) and immediately post-dialysis (t2) Comparison of the relative change of K+ECG at t2 versus t1
ECG maximum R wave height Pre- (t1) and immediately post-dialysis (t2) Comparison of the relative change of K+ECG at t2 versus t1
ECG P wave height Pre- (t1) and immediately post-dialysis (t2) Comparison of the relative change of K+ECG at t2 versus t1
ECG PR interval Pre- (t1) and immediately post-dialysis (t2) Comparison of the relative change of K+ECG at t2 versus t1
ECG QT interval Pre- (t1) and immediately post-dialysis (t2) Comparison of the relative change of K+ECG at t2 versus t1
Relative difference in change of K+Sa at t2 versus t1 Pre- (t1) and immediately post-dialysis (t2) Assess the performance of K+Sa compared to K+Pl
ECG ST segment depression Pre- (t1) and immediately post-dialysis (t2) Comparison of the relative change of K+ECG at t2 versus t1
ECG maximum T wave height Pre- (t1) and immediately post-dialysis (t2) Comparison of the relative change of K+ECG at t2 versus t1
- Secondary Outcome Measures
Name Time Method Percentage of false negative measurement, i.e. percentage where severe hyperkalemia [K+>6.0 mmol/L] was not detected by means of K+ECG, which was present in K+Pl Pre- (t1) and immediately post-dialysis (t2) Assess the performance of K+ECG compared to K+Pl
Percentage of false positive measurements, i.e. percentage where severe hyperkalemia [K+>6.0 mmol/L] was detected by means of K+ECG, which was not present in K+Pl Pre- (t1) and immediately post-dialysis (t2) Assess the performance of K+ECG compared to K+Pl
Severe hyperkalemia [K+Pl ≥ 6.5 mmol/L] detection rate using K+ECG: comparison of automated detection using the K+ECG algorithm vs experienced electrophysiologist. Pre- (t1) and immediately post-dialysis (t2) Assess the performance of K+ECG algorithm vs experienced electrophysiologist.
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Austria