This study is aimed at the development of a noninvasive method which leads to a more accurate and precise estimation of the creatinine clearance when compared with the Cockroft-Gault, MDRD or Nankivell formulas and taking the 24-hour urineā¦
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Estimation of the creatinine clearance using different methods
Secondary outcome
None
Background summary
The creatinine clearance is commonly accepted as the best parameter to asses
the kidney function. There are many different mathematical formulas to make an
estimation of the creatinine clearance. Most of them are based on the
measurement the serum creatinine concentration. The evaluation and availability
of various formulas taken with the fact that none of these formulas is adequate
for all patient populations can lead to confusion and misunderstanding in daily
practice when estimating kidney function.
In renal transplant recipients formulas that predict creatinine clearance (such
as the Cockcroft-Gault) derived from patients with chronic renal failure and
standardized against measured creatinine clearance are not accurate.
In these patients the relationship between serum creatinine and creatinine
clearance is more variable and dependent on factors (e.g. disease states) that
alter muscle mass and muscle catabolic rate.
Preceding research has shown that variables as age, sex, ethnicity, height and
weight explain a significant part of the variability of the kidney function.
It*s has been commonly accepted that these variables have a direct influence on
kidney function and are used combined with serum creatinine to estimate the
creatinine clearance. However these variables are also predictors of skeletal
muscle mass, the biggest source of creatinine, the clearance of which is used
to estimate the creatinine clearance .
Skeletal muscle mass can be predicted by the use of demographic variables but a
more accurate estimation method uses bioelectrical impedance analysis (BIA).
BIA is an easy non-invasive and convenient method to assess a patient*s total
body composition, including muscle mass. By measuring the total body
composition an accurate estimation of the muscle mass can be made
Study objective
This study is aimed at the development of a noninvasive method which leads to a
more accurate and precise estimation of the creatinine clearance when compared
with the Cockroft-Gault, MDRD or Nankivell formulas and taking the 24-hour
urine creatinine clearance as a reference in renal transplant recipients.
Using the formulas mentioned above (also see Methods) combined with bio
impedance measurements, we hypothesize that bio impedance will prove to have
additional value as a predictor of the muscle mass of a patient. This may lead
to a better prediction of the creatinine clearance than with currently used
methods.
Study design
Observational study
Study burden and risks
participants will have 4 electrodes (2 to hand, 2 to foot) placed for every BIA
measurement, after which a read-out takes place. The burden and risks can be
considered to be very small.
Postbus 22660
1100 DD Amsterdam
Nederland
Postbus 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- age 18 years and older
- medical history after renal transplantation carried out in the AMC
- admitted to the renal transplant unit (F5NS) or visiting the out-patient department of the AMC
- collecting 24-hour urine for the routine assessment of renal graft function
- giving written informed consent for participation to this study
Exclusion criteria
None
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 | NL23029.018.08 |