An interventional study of Sodium determination in Nocturia, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Basic science
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.
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.
134 studies on the registry are indexed under Nocturia; 22 are open to participants now.
This study's enrollment of 100 is above the median of 71 across 108 interventional studies indexed under Nocturia.
Browse Nocturia studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
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
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
Time frame: 1 hour
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Sep 2021, 4 months.
Of 34 interventional studies with no phase under Nocturia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 4 months is below that.
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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