HyperkalemiaNCT04251468
Clinical Potassium Pilot Study
A study testing GEPII and Ion-selective electrodes in people with Hyperkalemia, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- GEPII and Ion-selective electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 29 Apr 2020to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperkalemia
- Being tested
- GEPII, Ion-selective electrodes
- Keywords
- plasma potassium measurement, saliva potassium measurement, hemodialysis, fluorescence assay, ECG-based potassium estimation, Förster resonance energy transfer
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEPIIDevice
Saliva probes (K+Sa) will be measured using genetically encoded potassium ion indicators (GEPIIs)
Ion-selective electrodesDevice
Plasma potassium levels (K+Pl) will be measured using standard ion-selective electrodes.
| Study group | Role | What they receive |
|---|---|---|
| GEPII | Other | All patients who completed the study. Receives: Device: GEPII; Device: Ion-selective electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative difference in change of K+Sa at t2 versus t1
Assess the performance of K+Sa compared to K+Pl
Measured: Pre- (t1) and immediately post-dialysis (t2)
ECG P wave height
Comparison of the relative change of K+ECG at t2 versus t1
Measured: Pre- (t1) and immediately post-dialysis (t2)
ECG PR interval
Comparison of the relative change of K+ECG at t2 versus t1
Measured: Pre- (t1) and immediately post-dialysis (t2)
ECG QRS duration
Comparison of the relative change of K+ECG at t2 versus t1
Measured: Pre- (t1) and immediately post-dialysis (t2)
ECG maximum R wave height
Comparison of the relative change of K+ECG at t2 versus t1
Measured: Pre- (t1) and immediately post-dialysis (t2)
ECG QT interval
Comparison of the relative change of K+ECG at t2 versus t1
Measured: Pre- (t1) and immediately post-dialysis (t2)
ECG ST segment depression
Comparison of the relative change of K+ECG at t2 versus t1
Measured: Pre- (t1) and immediately post-dialysis (t2)
ECG maximum T wave height
Comparison of the relative change of K+ECG at t2 versus t1
Measured: Pre- (t1) and immediately post-dialysis (t2)
Secondary outcomes (3)
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
Assess the performance of K+ECG compared to K+Pl
Measured: Pre- (t1) and immediately post-dialysis (t2)
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
Assess the performance of K+ECG compared to K+Pl
Measured: 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.
Assess the performance of K+ECG algorithm vs experienced electrophysiologist.
Measured: Pre- (t1) and immediately post-dialysis (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start29 Apr 2020
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- NGFI Next Generation Fluorescence Imaging GmbH
- Responsible party
- Sponsor
- Investigators
- Alexander H. Kirsch, MD, Principal investigator, Medical University of GrazAndras T. Deak, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251468
- Sponsor's protocol ID
- CPPS
- Status last verified
- Sep 2020
- First submitted
- 27 Jan 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Potassium Pilot Study
- ClinicalTrials.gov ID
- NCT04251468
- Acronym / sponsor ID
- CPPS
- Conditions
- Hyperkalemia
- Keywords
- plasma potassium measurement, saliva potassium measurement, hemodialysis, fluorescence assay, ECG-based potassium estimation, Förster resonance energy transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- NGFI Next Generation Fluorescence Imaging GmbH
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GEPII | Other | Device: GEPII, Device: Ion-selective electrodesAll patients who completed the study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEPIISaliva probes (K+Sa) will be measured using genetically encoded potassium ion indicators (GEPIIs) | Device | GEPII |
| Ion-selective electrodesPlasma potassium levels (K+Pl) will be measured using standard ion-selective electrodes. | Device | GEPII |
Primary outcome
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
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander H. Kirsch, MD principal investigator
Medical University of Graz
Andras T. Deak, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEPII and Ion-selective electrodes in people with Hyperkalemia, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative difference in change of K+Sa at t2 versus t1 (time frame: Pre- (t1) and immediately post-dialysis (t2)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.