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Validation of Capillary Serum Sodium Levels

Primary Purpose

Nocturia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sodium determination
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nocturia focused on measuring nocturia, Desmopressin, Hyponatremia, Blood chemical analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Capillary and venous sodium

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 7, 2022
Last Updated
June 7, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05414279
Brief Title
Validation of Capillary Serum Sodium Levels
Official Title
Validation of Serum Sodium Levels Through Capillary Blood Collection Via Finger Prick Compared to Standard Venous Blood Sampling
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
October 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
nocturia, Desmopressin, Hyponatremia, Blood chemical analysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capillary and venous sodium
Arm Type
Other
Arm Description
From each patient a capillary and venous blood sample will be taken in order to determine the sodium level
Intervention Type
Diagnostic Test
Intervention Name(s)
Sodium determination
Intervention Description
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 Outcome Measure Information:
Title
Difference in sodium level between capillary and venous blood samples
Description
the agreement between capillary and venous sodium measurements, measured by the intra-class correlation coefficient
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Above 18 years or older admitted to the urology ward Exclusion Criteria: none
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
State/Province
East-Fanders
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Validation of Capillary Serum Sodium Levels

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