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

NCT02288663 | Unknown

• 1 other identifier: 5744
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Function

Outcome Measures

Primary Outcomes (1)

• SCr and LBM estimated from DXA

  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.

  Each participant is followed for one day.

Secondary Outcomes (7)

• 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.

Study Arms (1)

Freage group

OTHER

only one group in this trial. All the participants will follow all the listed interventions.

Other: measurement of morphological parameters; Biological: a blood sample; Biological: albumin or blood in urine; Device: Dual X-ray absorptiometry (DXA); Device: Bioelectric Impedance Spectroscopy (BIS); Biological: 51Cr-EDTA plasma clearance

Interventions

measurement of morphological parameters OTHER

measurement of morphological parameters : thigh perimeter, leg perimeter, arm perimeter.

Freage group

a blood sample BIOLOGICAL

One single blood sample to assay SCr (enzymatic), BUN (blood urea nitrogen), cystatin C, CRP, Na, K, Cl, albuminemia.

Freage group

albumin or blood in urine BIOLOGICAL

dipstick analysis for albumin or blood in urine

Freage group

Dual X-ray absorptiometry (DXA) DEVICE

measurement of lean body mass by whole-body DXA

Freage group

Bioelectric Impedance Spectroscopy (BIS) DEVICE

measurement of lean body mass by BIS

Freage group

51Cr-EDTA plasma clearance BIOLOGICAL

measurement of 51Cr-EDTA plasma clearance to determine GFR

Freage group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• age of 75 years of more
• origin from Western Europe or North Africa
• covered by social health insurance
• general health condition allowing transportation and ambulatory procedures during one day

You may not qualify if:

• ascitis, oedema or third compartment
• fast change in body weight (more than 5% in less than one week)
• eGFR \< 30 mL/min/1.73 m² (using MDRD formula)
• legal concerns: prisoners, guardianship, lack of health insurance, failure to consent
• intake of drugs that interfere with creatinine tubular secretion
• cimetidine
• trimethoprim
• intake of drugs that interfere with creatinine assay
• calcium dobesilate
• hydroxocobalamin
• N-ethylglycine
• phenindione
• lidocaine
• inability to lie during 10 minutes without moving
• patients who are bedridden, hemiplegic or highly dependent on others

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Interventions

Albumins; Blood Specimen Collection; Urination; Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical

Central Study Contacts

Emmanuel DURAND, Professor

CONTACT

3 69 55 04 58; durandem@club-internet.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: November 11, 2014
• Study Start: November 3, 2014
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

FR (1)