Validation of Capillary Serum Sodium Levels

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT05414279

Collaborator

(none)

100

Enrollment

Location

Arm

5.2

Actual Duration (Months)

19.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nocturia	Diagnostic Test: Sodium determination	N/A

Detailed Description

Currently, serum sodium levels are determined by standard venous blood sampling. This method is invasive, painful and a relatively large amount of blood is drawn (5ml). Repeated blood draws are necessary in certain patient groups. If sodium values can be determined on a capillary blood sample instead of a classic venous blood sample, the total blood volume will be smaller. In addition, in the future, the aim is to perform capillary blood sampling at home and to send the sample by courier, thus saving the patient a trip to the doctor's office or a nurse at home.

The aim of this prospective interventional study is to validate the sodium values on a capillary blood sample obtained via fingerstick (250µL). To demonstrate that the obtained values are reliable and clinically useful they will be compared one-on-one with the sodium values determined on a standard venous blood sample. Since it is important to validate a broad range of sodium values, a heterogeneous study population is chosen to obtain sufficient variation.

Patients admitted to the Urology department at UZ Gent will be informed verbally and in writing about the content and purpose of the study. If they are interested in participating, they will be asked to sign the consent form. At the moment the already planned venous blood collection, a capillary blood sample will be taken as well via a finger prick. A number of blood drops (250 µL) are collected in a standard Lithium-Heparin tube and will be collected by lab Maenhout for further analysis. The venous blood sample, which is taken as part of the therapy/diagnosis (independent of the study, standard of care) during admission, is analyzed by the clinical lab of UZ Gent.

The sodium values from the capillary blood draw will be compared with the values from the venous blood draw, with each patient acting as their own control. There is no need to have the venous blood samples analyzed by Labo Maenhout, as the clinical lab of UZ Gent uses the same technique for sodium determination (indirect determination) as Labo Maenhout.

The sodium values obtained through capillary and venous blood sampling will be statistically analyzed using a Passing-Bablok regression model.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Validation of Serum Sodium Levels Through Capillary Blood Collection Via Finger Prick Compared to Standard Venous Blood Sampling

Actual Study Start Date :

Apr 30, 2021

Actual Primary Completion Date :

Sep 29, 2021

Actual Study Completion Date :

Oct 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Capillary and venous sodium From each patient a capillary and venous blood sample will be taken in order to determine the sodium level	Diagnostic Test: Sodium determination 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

Arm

Intervention/Treatment

Other: Capillary and venous sodium

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

Diagnostic Test: Sodium determination

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

Outcome Measures

Primary Outcome Measures

Difference in sodium level between capillary and venous blood samples [1 hour]
the agreement between capillary and venous sodium measurements, measured by the intra-class correlation coefficient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Above 18 years or older
admitted to the urology ward

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Ghent	East-Fanders	Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT05414279

Other Study ID Numbers:

BC-09422

First Posted:

Jun 10, 2022

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Ghent

nocturia

Desmopressin

Hyponatremia

Blood chemical analysis

Additional relevant MeSH terms:

Nocturia

Study Results

No Results Posted as of Jun 10, 2022