To determine the value of cystatine-c based renal function assessment in adults with spina bifida when compared to the golden standard of 24-hours urine collection.
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation coefficient of GFR as determined by cystatine-c compared to GFR
according to the golden standard.
Secondary outcome
None.
Background summary
The current method to assess renal function in spina bifida patients is serum
creatinine with an estimated GFR. However, it is known that this method is not
reliable in those with a reduced lean body mass, for instance because of
neuromuscular disorders. Cystatine-c could be a more reliable alternative for
rapid determination of renal functioning in this specific subset of patients.
Besides, it is easy to determine and quite cheap when compared to the current
golden standard methods (e.g. 24-hours urine collection).
Study objective
To determine the value of cystatine-c based renal function assessment in adults
with spina bifida when compared to the golden standard of 24-hours urine
collection.
Study design
Prospecitve, diagnostic, non-therapeutical.
Study burden and risks
There is a very small risk of urinary tract infection and irritative symptoms
due to the urinary catheter.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
* Patients with OSD (open spinal dyraphism; myelomeningocele or meningocele), or CSD (closed spinal dysraphism; all varieties of occult spina bifida including, for instance, caudal regression syndrome).
* Age > 18 years;
* Adequate cognitive functioning;
* Patient's willingness to participate;
Exclusion criteria
* Severe mental retardation;
* Hemodialyse of peritoneaaldialyse.
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 | NL43022.041.12 |