The objective of this study is to determine the accuracy of the Cockcroft-Gault and the MDRD formula as estimators of GFR in geriatric patients. Some other new methods for daily practice will be investigated as well (see primairy parameters).
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Following referencetest is applied to every participant as the primairy
parameter.
· Inutest *single-shot* method, to measure sinistrin clearance, in ml/min.
Next methods are secondary parameters and will be compared with the reference
method:
· Cockcroft-Gault formula in ml/min.
· MDRD formula in ml/min/173m²
• MCQ-formula in ml/min
• Virga-formula in ml/min
• Jelliffe-formula in ml/min
• Salazar-Corcoran-formula in ml/min
• Martin-formula in ml/min
• Wright-formula in ml/min
• Larsson-formula in ml/min
• Hoek-formula in ml/min
· Creatinine clearance estimation form 2-hour urine sample, in ml/min.
· Cystatine C plasma concentration, in mg/l
To estimate GFR with the formulas, following variables must be collected :
· Serum creatinine concentration
· Serum ureum concentration
· Serum albumin concentration
· Serum Cystatine C concentration
· Gender
· Race
· Date of birth
· Body Mass Index (BMI)
Secondary outcome
Following participant features will be collected for baseline table:
- primairy diagnosis
- co-morbidities
- drugs used
Background summary
The estimation of renal function is an important tool for physicians who work
with elderly or geriatric patients. Elderly patients have a high incidence of
impaired renal function and are prone to adverse drug reactions and acute
illness. Within the pharmaco-therapeutic proces, glomerular filtration rate
(GFR) estimation can therefore be used as a motivator for drug dose adjustments.
Recently new methods for GFR estimation have been introduced for daily clinical
practice. Two formulas, the Cockcroft-Gault and the Modification of Diet in
Renal Disease (MDRD) formula, have gained a lot more popularity than the old
method of plasma creatinine measurement on its own. Besides the plasma
creatinine, these formulas are also based on variables such race, age and
weight. Most guidelines, recommend the use of these formulas for GFR
estimation, but the evidence is based on validations in adult populations. Only
little evidence is known for the accuracy of formulaic GFR estimation in
geriatric medicine. Studies who investigated the accuracy of the formulas in
geriatric patients, are inconsistent with the use of their reference method and
have different outcomes as well.
Study objective
The objective of this study is to determine the accuracy of the Cockcroft-Gault
and the MDRD formula as estimators of GFR in geriatric patients. Some other new
methods for daily practice will be investigated as well (see primairy
parameters).
Study design
To determine the accuracy of different formulas and methods, a comparison with
a reference test will be made. Different reference methods for GFR measurement
are known, but the inulin clearance is recommended by evidence based guidelines
as the golden standard.
In this study, the inuline clearance will be measured by the use of Inutest.
Inutest contains the totally passive substance of sinistrin. Sinistrin is an
improved version of inulin. Participants will get a injection of sinistrin
solution. After the injection, multiple blood samples will be gathered. This
procedure will take one day and is done on our geriatric ward. At the same
time, GFR will be estimated with the formulas and be compared with the golden
standard Inutest.
Study burden and risks
Inutest contains a solution of sinistrin, which is a totally passive fructose
for the human body. It is not bonded to plasma proteines and fully cleared by
the kidneys. There are no adverse drug reactions or interactions with other
drugs known. There is a very small chance of allergic reaction to sinistrin.
Participants will get one intraveneus injection of sinistrin and one
intraveneus device for multiple blood collection. There will be a 2-hour urine
collection gathered with non-invasive methods.
heidelberglaan 100
3584CX Utrecht
Nederland
heidelberglaan 100
3584CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Decision-making competence, aged > or = 70, MDRD < or = 60 ml/min, clinical and outward patients, stable clinical condition
Exclusion criteria
Decision-making incompetence;Terminal stadium of disease
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 | NL19442.041.07 |