NCT05414279

Brief Summary

Prospective interventional study to determine sodium levels in capillary blood via finger prick. The goal is to determine if this technique is suitable and equal to a standard venous blood collection for the analysis of blood sodium levels.The purpose is to compare both sodium levels to determine if they are equal so the technique can be used in a clinical setting for people who need regular blood collections for the determination of sodium, for example after the start of desmopressin use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 7, 2022

Last Update Submit

June 7, 2022

Conditions

Nocturia

Keywords

nocturiaDesmopressinHyponatremiaBlood chemical analysis

Outcome Measures

Primary Outcomes (1)

  • Difference in sodium level between capillary and venous blood samples

    the agreement between capillary and venous sodium measurements, measured by the intra-class correlation coefficient

    1 hour

Study Arms (1)

Capillary and venous sodium

OTHER

From each patient a capillary and venous blood sample will be taken in order to determine the sodium level

Diagnostic Test: Sodium determination

Interventions

Sodium determinationDIAGNOSTIC_TEST

Through a single finger prick 10 drops of capillary blood will be drawn. The venous blood sample will be taken through a standard venipuncture. Both samples will be send to the lab for indirect sodium determination

Capillary and venous sodium

Eligibility Criteria

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

You may qualify if:

  • Above 18 years or older
  • admitted to the urology ward

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, East-Fanders, 9000, Belgium

Location

MeSH Terms

Conditions

NocturiaHyponatremia

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 10, 2022

Study Start

April 30, 2021

Primary Completion

September 29, 2021

Study Completion

October 5, 2021

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)