NCT04907773

Brief Summary

This is an open, prospective, and interventional study investigating the potassium measurement with the CardioRenal device in capillary blood. It will be conducted at one investigational site. Each subject will have capillary blood collections. Additionally as a reference a venous blood collection will be conducted

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

November 1, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

May 21, 2021

Last Update Submit

October 25, 2021

Conditions

Potassium Measurement

Keywords

hemolysiscapillary collection

Outcome Measures

Primary Outcomes (1)

  • Correlation between venous whole blood potassium with available point of care device and capillary potassium with CardioRenal device

    through study completion, an average of 1 month

Secondary Outcomes (4)

  • Correlation between capillary potassium with available point of care device and capillary potassium with Cardiorenal device

    through study completion, an average of 1 month

  • Correlation between plasma potassium from venous puncture with lab test and capillary potassium with Cardiorenal device

    through study completion, an average of 1 month

  • Correlation between venous whole blood potassium and capillary potassium measurement with available point of care device

    through study completion, an average of 1 month

  • Correlation between plasma potassium from venous puncture with lab test and plasma potassium from venous puncture with Cardiorenal device

    through study completion, an average of 1 month

Other Outcomes (2)

  • Correlation from capillary freeHb and capillary potassium

    through study completion, an average of 1 month

  • Degree of haemolysis in capillary blood tests compared to venous blood test

    through study completion, an average of 1 month

Study Arms (1)

Potassium measurement

OTHER
Other: Capillary blood samplingOther: Venous blood samplingOther: Arterio-venous blood sampling

Interventions

Capillary blood samplingOTHER

Each subject will have one to two capillary blood collections.

Potassium measurement
Venous blood samplingOTHER

Each healthy subject will also have a reference venous blood collection.

Potassium measurement
Arterio-venous blood samplingOTHER

Each hemodialysed subject will also have a reference arterio-venous blood collection.

Potassium measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (Age Over 18 yo)
  • Healthy volunteers
  • Chronic Hemodialysed patients
  • Pre-dialysis patient, taken off after the long interdialytic interval (\> 2 days)
  • AND with a K+ \> 5.0 mmol/L just before starting the dialysis session (screening checked on venous or arterio-venous blood sample)
  • Post-dialysis, in patients treated with a 2 mmol/l dialysis bath
  • AND with a K+ \< 3.5 mmol/L at the end of the dialysis session (screening checked on venous or arterio-venous blood sample)

You may not qualify if:

  • No consent
  • Age \<18 yo
  • Medical history of crisis (epilepsy)
  • Known inherited hemolytic anemia
  • Autoimmune hemolytic anemia
  • Infectious Hemolytic anemia
  • Prosthetic Cardiac valves
  • Hemolytic uremic syndrome
  • Peripheral edema
  • Dehydration
  • Peripheral Arterial Obstructive Disease (PAOD)
  • Raynaud syndrome
  • Known evolutive cancers
  • Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

MeSH Terms

Conditions

Hemolysis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Damien Gruson, Prof

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Potassium measurement
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2021

First Posted

June 1, 2021

Study Start

July 1, 2021

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

November 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)