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临床试验/NCT04251468
NCT04251468已完成不适用

Clinical Potassium Pilot Study

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2020年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
ECG QRS duration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

ECG QRS duration

时间窗: Pre- (t1) and immediately post-dialysis (t2)

Comparison of the relative change of K+ECG at t2 versus t1

ECG maximum R wave height

时间窗: Pre- (t1) and immediately post-dialysis (t2)

Comparison of the relative change of K+ECG at t2 versus t1

ECG P wave height

时间窗: Pre- (t1) and immediately post-dialysis (t2)

Comparison of the relative change of K+ECG at t2 versus t1

ECG PR interval

时间窗: Pre- (t1) and immediately post-dialysis (t2)

Comparison of the relative change of K+ECG at t2 versus t1

ECG QT interval

时间窗: 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

时间窗: Pre- (t1) and immediately post-dialysis (t2)

Assess the performance of K+Sa compared to K+Pl

ECG ST segment depression

时间窗: Pre- (t1) and immediately post-dialysis (t2)

Comparison of the relative change of K+ECG at t2 versus t1

ECG maximum T wave height

时间窗: Pre- (t1) and immediately post-dialysis (t2)

Comparison of the relative change of K+ECG at t2 versus t1

次要结局

  • 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))
  • 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))
  • 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))

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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