We want to prove wheter the A1M/creatinine ratio in the urine is a good marker to diagnose an APN, or not. The study design has been made of a prospective observational cohort, controlled by a DMSA-scan.Our aim is to use the A1M/creatinine marker in…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We want to prove the diagnostic value of alpha-1-microglobulin/creatinine ratio
in urine in comparisson to the best diagnostic option at this moment to prove
an APN, a DMSA-scan.
Secondary outcome
none
Background summary
At this moment it is not easy for a pediatrician to diagnose an acute
pyelonephritis (APN). An APN is a serious problem, requesting accurate therapy
and follow up. The pediatrician uses a couple of diagnostic options: his own
clinical findings, urine-screening and sometimes, when he is not sure, a 99Tc
dimercaptosuccin acid scan (DMSA-scan). The DMSA-scan seems to be the best
diagnostic option, in comparisson to histopathological finding, in case of an
APN.
In a couple of non-prospective studies a protein called Alpha-1-microglobuline
seems to be a good option to make an APN sure. The A1M concentration has to be
measured out of the urine. The quantity is being exspressed in mg/g creatinine
in the urine. When there is a bacterial focus in the pyelum of the nephron, the
ratio increases significantly. This ratio does not increase in case of a lower
urinary tract infection nor it does when the inflammatoiry focus is situated
outside the urinary tract. The measurement of A1M/creatinine is in comparisson
to other diagnostics cheap, quick and probably it has got enough power to make
an APN sure or to exclude it.
Study objective
We want to prove wheter the A1M/creatinine ratio in the urine is a good marker
to diagnose an APN, or not. The study design has been made of a prospective
observational cohort, controlled by a DMSA-scan.
Our aim is to use the A1M/creatinine marker in the future as a quick, cheap,
good marker to diagnose an APN without an intervention. And to prevent the
patient from invasive examens or profylactic antibiotics.
Study design
In this study we are proving the diagnostic value of the A1M/creatinine ratio
in urine in comparisson to the DMSA-scan. When the urine has sedimental
changes, the patient surely has a urinary tract infection; the inflammatory
focus may be presented as an APN or a lower urinary tract infection (LUTI). A
DMSA-scan will procedured in all patients with an abnormal urine sediment and
fever. We will compare our results to normal urine sediment patients with fever
or/and patients with abnormal urinesediment without fever. In these patients
there won't be a DMSA-scan made.
Two weeks after lowering fever we want measure the A1M/creatinine ratio again
in all patients included.
Study burden and risks
neglectable
Langendijk 75
4819 EV Breda
Nederland
Langendijk 75
4819 EV Breda
Nederland
Listed location countries
Age
Inclusion criteria
fever of unknown origine or with symptoms of the urinary tract
Exclusion criteria
preexistent nephropathy, hypertension, artery renalis stenosis, diabetes mellitus, sepsis, immunosuppressive drugs
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL14095.101.06 |