To compare the accuracy of the measured GFR using bolus 51Cr-EDTA, and Gd DTPA, and estimated GFR using cystatin C and creatinine with the continuous 125I-labelled iothalamate infusion method.
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracies of GFR determination using 51Cr-EDTA, Gd-DTPA, cystatin C (using
the Hoek-formula) and creatinine (using the MDRD - and Cockcroft and Gault
formula) will be compared to continuous 125I-labelled iothalamate/
131I-labelled hippuran infusion as gold standard.
Secondary outcome
1. Gd-DTPA, cystatin C (using the Hoek-formula) and creatinine (using the MDRD
- and Cockcroft and Gault formula) will be compared to 51Cr-EDTA.
2. Subanalysis of these parameters in the four different patients groups.
Background summary
In patients at risk of developing renal failure, adequate measurement of
glomerular filtration rate (GFR) is of utmost importance. In case of
deterioration of renal function, treatment if possible of the underlying cause
must be initiated without delay; treatment in an early stage of kidney failure
is most effective.
Many attempts have been made to find an ideal method to determine GFR. GFR can
be measured or can be calculated. So far, inuline clearance or infusion with
radio-active substances are considered gold standard, but they are. expensive
and cumbersome. There is a need for easier and cheaper methods.
Gd DTPA is a newly developed method to determine renal function after the a
single injection with gadolineum. Cystatin C is a relatively new endogenous
marker to asses renal function. If Gd-DTPA and/or Cystatin C show a good
correlation with the 'gold standard' using 125I-labelled iothalamate in a
continuous infusion method or bolus infusion of
51-chromium-ethylenediaminetetraacetic acid (51Cr-EDTA), they could replace
these methods in the future.
Study objective
To compare the accuracy of the measured GFR using bolus 51Cr-EDTA, and Gd DTPA,
and estimated GFR using cystatin C and creatinine with the continuous
125I-labelled iothalamate infusion method.
Study design
Crossectional study in patients at risk of developing renal failure. GFR will
be determined using 125I-labeled iothalamate, 51Cr-EDTA, Gd DTPA, a cystatin
C-based formula and a creatinine-based formula.
Study burden and risks
The persons participating in the study have to come to the hospital for one
extra day. On this day they will undergo several investigations which in total
will last about 5 hours. They will be given an intravenous catheter in the
right and left ante-cubital vein through which gadolineum and radio-active
chromium will be administered and blood will be drawn. Allergic reactions after
adminstration of gadolineum and chromium have been reported (rare). After the
administration of gadolineum in a 20x higher dose, nephrogenic systemic
fibrosis has been reported, and only in patients with end-stage renal disease.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- > 18 years
-Patients have to belong to one of the following categories: those with Fabry disease, those with HIV, those with a status after renal transplantation or those that are willing to donate a kidney.
-Patients (from the outpatient clinic of metabolic diseases and infectious diseases) in whom renal function was measured with 125I-labeled iothalamate/131I-labeled hippuran GFR in the previous year (i.e patients with Fabry disease or with HIV).
-Stable renal function as estimated by a stable serum creatinine during the previous year.
Exclusion criteria
-Female patients who are pregnant or unwilling to use adequate contraception during the study.
-A known allergy to either 51Cr-EDTA or gadolineum DTPA (Magnevist).
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 | NL20756.018.08 |