Clinical Potassium Pilot Study

NCT04251468 | Completed

• 1 other identifier: CPPS
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia

Keywords

plasma potassium measurement; saliva potassium measurement; hemodialysis; fluorescence assay; ECG-based potassium estimation; Förster resonance energy transfer

Outcome Measures

Primary Outcomes (8)

• Relative difference in change of K+Sa at t2 versus t1

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

  Pre- (t1) and immediately post-dialysis (t2)

• ECG P wave height

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

  Pre- (t1) and immediately post-dialysis (t2)

• ECG PR interval

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

  Pre- (t1) and immediately post-dialysis (t2)

• ECG QRS duration

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

  Pre- (t1) and immediately post-dialysis (t2)

• ECG maximum R wave height

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

  Pre- (t1) and immediately post-dialysis (t2)

• ECG QT interval

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

  Pre- (t1) and immediately post-dialysis (t2)

• ECG ST segment depression

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

  Pre- (t1) and immediately post-dialysis (t2)

• ECG maximum T wave height

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

  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

  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

  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)

Study Arms (1)

GEPII

OTHER

All patients who completed the study.

Device: GEPII; Device: Ion-selective electrodes

Interventions

GEPII DEVICE

Saliva probes (K+Sa) will be measured using genetically encoded potassium ion indicators (GEPIIs)

GEPII

Ion-selective electrodes DEVICE

Plasma potassium levels (K+Pl) will be measured using standard ion-selective electrodes.

GEPII

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• NGFI Next Generation Fluorescence Imaging GmbH: collaborator

Study Sites (1)

Medical University of Graz

Graz, Austria

Location

MeSH Terms

Conditions

Hyperkalemia

Interventions

Ion-Selective Electrodes

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Alexander H. Kirsch, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Andras T. Deak, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: April 29, 2020
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)