Renal Function Assessment in the Elderly Using Plasma Creatinine Assay and Lean Body Mass Measurement
NCT ID: NCT02288663
Last Updated: 2021-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
220 participants
INTERVENTIONAL
2014-11-03
2022-11-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With a GFR Below 60 mL/Min/1.73 m²
NCT07042698
Accuracy of Glomerular Filtration Rate (GFR) Estimation Using Creatinine and Cystatin C and Albuminuria
NCT02433002
Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast
NCT04597892
Bariatric Surgery for Obese Patients With Chronic Renal Insufficiency
NCT02612831
Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30
NCT04598516
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Freage group
only one group in this trial. All the participants will follow all the listed interventions.
measurement of morphological parameters
measurement of morphological parameters : thigh perimeter, leg perimeter, arm perimeter.
a blood sample
One single blood sample to assay SCr (enzymatic), BUN (blood urea nitrogen), cystatin C, CRP, Na, K, Cl, albuminemia.
albumin or blood in urine
dipstick analysis for albumin or blood in urine
Dual X-ray absorptiometry (DXA)
measurement of lean body mass by whole-body DXA
Bioelectric Impedance Spectroscopy (BIS)
measurement of lean body mass by BIS
51Cr-EDTA plasma clearance
measurement of 51Cr-EDTA plasma clearance to determine GFR
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
measurement of morphological parameters
measurement of morphological parameters : thigh perimeter, leg perimeter, arm perimeter.
a blood sample
One single blood sample to assay SCr (enzymatic), BUN (blood urea nitrogen), cystatin C, CRP, Na, K, Cl, albuminemia.
albumin or blood in urine
dipstick analysis for albumin or blood in urine
Dual X-ray absorptiometry (DXA)
measurement of lean body mass by whole-body DXA
Bioelectric Impedance Spectroscopy (BIS)
measurement of lean body mass by BIS
51Cr-EDTA plasma clearance
measurement of 51Cr-EDTA plasma clearance to determine GFR
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* origin from Western Europe or North Africa
* covered by social health insurance
* general health condition allowing transportation and ambulatory procedures during one day
Exclusion Criteria
* 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
* any health condition that, in the investigator's opinion, could rapidly (\< 1 week) vary the extracellular volume or GFR (these is voluntarily left open to the investigator because it is hardly possible to make an exhaustive list here)
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Strasbourg, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5744
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.