Validation of Capillary Serum Sodium Levels

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.

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Key information

Conditions

Nocturia Hyponatremia Lower Urinary Tract Symptoms Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, East-Fanders, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Above 18 years or older
admitted to the urology ward

Exclusion criteria

none

Treatment and study plan

Sodium determination

Diagnostic 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

Primary outcomes

Difference in sodium level between capillary and venous blood samples

Time frame: 1 hour

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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Jun 10, 2022
Registry last updated: Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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