Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02671656 |
| Other study ID # |
UC1501 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2016 |
| Est. completion date |
April 2016 |
Study information
| Verified date |
June 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Lowering the level of uric acid in the serum under 6mg/dL on the long term is a key factor of
gout management success. Monitoring of uricemia in gout patients is therefore important and
is presently done in the laboratory on serum samples obtained after venous puncture. This
study aims at assessing the reliability of immediate uricemia measurement in a blood sample
obtained by a mere fingertip puncture, by the HumaSensplus system, which is commercially
available in the EU. Results obtained by the Humasens device will be compared to those of the
standard measurement technique in serum and with a reference technique (liquid chromatography
and mass spectroscopy). If the device appears reliable, it will allow self-measurement of
uric acid by the gouty patient, in a similar way as diabetic patients measure their glycaemia
following a fingertip puncture. This should improve patient monitoring and management
effects.
Description:
The aim of this study is
- to assess the validity of the capillary measure of uric acid level by the HumaSens plus
system by comparing the measurement of total blood uric acid level by the HumaSens plus
system with the routine measurement of serum uric acid by a standard and validated
automated colorimetric method (primary objective).
- to look for a systematic bias and confounding factors (secondary objectives)
Methods
Design : This is a mono-centric prospective study. Patients will be recruited from the
diabetology day hospital of hospital Lariboisière, Paris
Data collection : For each patient included at the Lariboisière Diabetology day hospital and
included in this study, serum uric acid levels will be measured once from venous blood
samples in the biochemistry laboratory using standard automated colorimetric methods, as
presently routinely done and by liquid chromatography coupled with mass spectroscopy. In,
addition, uric acid levels will also be simultaneously measured from capillary blood with the
HumaSensplus system.
Hematocrit, glucose, cholesterol and triglycerides will be measured as well from venous blood
samples and taken medications will be listed.
Planned analysis :
Planned sample size:
To obtain an estimated intraclass correlation of 0,800, with a two-sided 95% confidence
interval with a width of 0,100, if the uric acid level is measured twice for each subject, we
calculated that we needed a random sample of 204 subjects.
Statistical analyses:
Primary aim This study aims at studying the reliability of measurements of acid uric level by
HumanSensplus against laboratory and measurements by liquid chromatography coupled with mass
spectroscopy on serum from venous blood. There is no structure to the replicate measurements
in the sense that nothing ties the first or second measurement on one patient to the first or
second on another. The study thus conforms to a one-way random effect model. The data will be
analyzed using a one-way random-effects ANOVA model.
The estimator of the intraclass correlation coefficient will be
With BMS=between-subject mean square, WMS=within-subject mean square and k0 = number of
replicates. In this study k0=2.
The intraclass correlation coefficient will be calculated and the two-sided 95%CI will be
provided for each comparison.
In addition differences between measurements will be plotted against mean of measurements in
accordance with Bland and Altman.
Secondary aims The search for systematic bias and effect of confounding factors (hematocrit,
glycemia, lipid concentrations and concomitant medications) will use different models of
multiple regression
Logistic aspects
Ethical aspects:
Agreement will be sought from the local Ethics committee. All patients will be fully informed
and will be provided with an information form. The data will be entered into an excel
database and will be analysed anonymously. Fingertip glycaemia is presently systematically
obtained in all these day hospital patients, and the addition of fingertip uricaemia in view
of substituting this measurement to the systematic serum uric acid measurement presently done
from a venous system in the biochemistry laboratory can be considered as a mere attempt to
improve routine patient care.
Inclusion procedure:
The study will target 200 patients seen in diabetology day hospitalisation and fulfilling the
inclusion criteria. As 15 patients are seen in the diabetology day hospitalisation ward every
day, we estimate that the necessary patients sample size could be obtained within 6 weeks.
