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Clinical Trials/NCT02288663
NCT02288663
Unknown
Not Applicable

Renal Function Assessment in the Elderly Using Plasma Creatinine Assay and Lean Body Mass Measurement

University Hospital, Strasbourg, France1 site in 1 country220 target enrollmentNovember 3, 2014
ConditionsRenal Function

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Function
Sponsor
University Hospital, Strasbourg, France
Enrollment
220
Locations
1
Primary Endpoint
SCr and LBM estimated from DXA
Last Updated
4 years ago

Overview

Brief Summary

Glomerular filtration rate (GFR) is the recommended parameter to assess renal function. The reference technique to measure GFR (clearance of a glomerular agent) is not commonly used. Instead, estimations (eGFR) are routinely taken from serum creatinine (SCr) with several published formulae: Cockcroft and Gault, MDRD, CKD-EPI. Basically, all these formulae aim at predicting the endogenous creatinine production by morphological parameters (age, body weight...) However, in the elderly, muscular mass is extremely variable and sarcopenia is quite commonly encountered (frequently linked to Alzheimer disease). This is probably the main reason why the aforementioned formulae are not valid in this population: for a given renal function, a lower muscular mass induces a lower creatinine production and, henceforth, a lower SCr value, which gives an overestimation of eGFR.

Muscular mass is closely linked to lean body mass (LBM), which can be properly assessed by whole-body dual X-ray absorptiometry (DXA). Alternatively, Bioelectric Impedance Spectroscopy (BIS) can also be used.

Investigators postulate that it is possible to estimate GFR in the elderly from both SCr and LBM estimation from DXA. Proof of concept has already been made by others but until now, no specific formula for the elderly has been devised and properly validated.

Investigators'aim is thus to propose a new formula to predict GFR from both SCr and LBM (estimated from DXA) in the elderly. This formula will be elaborated from a first series of 100 patients and validated on a second series of 100 other patients.

Registry
clinicaltrials.gov
Start Date
November 3, 2014
End Date
November 2, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

SCr and LBM estimated from DXA

Time Frame: Each participant is followed for one day.

The formula that will be designed (using SCr and LBM estimated from DXA) from the first 100 patient data, will match measured GFR (as given by 51Cr-EDTA clearance) with less than 10 mL/min/1.73 m² absolute error in more than 90% of the other 100 patients.

Secondary Outcomes

  • SCr and lean body mass ( by DXA)(Each participant is followed for one day.)
  • SCr and lean body mass (by BIS)(Each participant is followed for one day.)
  • SCr and morphological parameters(Each participant is followed for one day.)
  • Accuracy of new formulae(Each participant is followed for one day.)
  • Precision of new formulae(Each participant is followed for one day.)
  • Sensitivity of new formulae(Each participant is followed for one day.)
  • Specificity of new formulae(Each participant is followed for one day.)

Study Sites (1)

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