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Clinical Potassium Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251468
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
NGFI Next Generation Fluorescence Imaging GmbH
Information provided by (Responsible Party):
Medical University of Graz

Tracking Information
First Submitted Date  ICMJE January 27, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE April 29, 2020
Actual Primary Completion Date September 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • Relative difference in change of K+Sa at t2 versus t1 [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Assess the performance of K+Sa compared to K+Pl
  • ECG P wave height [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG PR interval [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG QRS duration [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG maximum R wave height [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG QT interval [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG ST segment depression [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG maximum T wave height [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Comparison of the relative difference in change of K+Sa at t2 versus t1 [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Assess the performance of K+Sa compared to K+Pl
  • ECG P wave height [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG PR interval [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG QRS duration [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG maximum R wave height [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG QT interval [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG ST segment depression [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
  • ECG maximum T wave height [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Comparison of the relative change of K+ECG at t2 versus t1
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • 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 [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Assess the performance of K+ECG compared to K+Pl
  • 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 [ Time Frame: 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. [ Time Frame: Pre- (t1) and immediately post-dialysis (t2) ]
    Assess the performance of K+ECG algorithm vs experienced electrophysiologist.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Potassium Pilot Study
Official Title  ICMJE Clinical Potassium Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hyperkalemia
Intervention  ICMJE
  • Device: GEPII
    Saliva probes (K+Sa) will be measured using genetically encoded potassium ion indicators (GEPIIs)
  • Device: Ion-selective electrodes
    Plasma potassium levels (K+Pl) will be measured using standard ion-selective electrodes.
Study Arms  ICMJE GEPII
All patients who completed the study.
Interventions:
  • Device: GEPII
  • Device: Ion-selective electrodes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
30
Actual Study Completion Date  ICMJE September 9, 2020
Actual Primary Completion Date September 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251468
Other Study ID Numbers  ICMJE CPPS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE NGFI Next Generation Fluorescence Imaging GmbH
Investigators  ICMJE
Principal Investigator: Alexander H. Kirsch, MD Medical University of Graz
Principal Investigator: Andras T. Deak, MD Medical University of Graz
PRS Account Medical University of Graz
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP