Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With a GFR Below 60 mL/Min/1.73 m²

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Glomerular filtration rate (GFR), which is the main biomarker used in clinical practice to assess kidney function, is usually estimated from the serum concentration of endogenous markers such as creatinine and/or cystatin C. GFR estimation equations all share the disadvantage of imperfect accuracy due to non-GFR-related determinants of creatinine and cystatin C. When knowing the exact GFR value is necessary for clinical decision-making, measurement by clearance of an exogenous tracer is required. Various tracers are available, some of which are radioactive tracers (99mTc-DTPA and 51Cr-EDTA), while others are iodinated contrast agents (iohexol, iothalamate). GFR measurement procedures are time-consuming and require significant human resources (4 to 5 hours, or even 24 hours for plasma clearances at very low GFR values).Urinary clearance methods may be inaccurate in cases of inadequate voiding. Plasma clearance results may be inaccurate in cases of increased (overestimation) or decreased (underestimation) extracellular volume, low GFR (unless late sampling is performed), or glomerular hyperfiltration. Measuring tracers requires either warm labs for measuring radioactive markers or labs with HPLC (High Performance Liquid Chromatography) chains for iohexol, which are part of an external quality assurance program. The complexity and/or length of GFR measurement procedures, their cost, and laboratory constraints explain why measured GFR is underused in routine clinical practice. There is a critical need to develop GFR measurement methods that are simpler to implement, reliable across the entire GFR spectrum, and widely available. We have demonstrated that it is possible to measure GFR using 4-phase CT urography performed as part of the care of living kidney donor candidates (healthy individuals with normal GFR). The examination takes 10 minutes, requires no biological sampling, and is not subject to potential inaccuracies due to sodium overload or poor bladder emptying.

Eligibility criteria

Qualifiers

Patients older than 18 years of age

Having given written consent to participate in the study

Patient referred to the medical imaging department of the Henri Mondor University Hospital for a 3-phase or 4-phase abdominal CT scan

With an estimated GFR according to CKD-EPIcreat2009 < 60 ml/min/1.73m²

Disqualifiers

Patients with hip implants, due to artifacts that make quantification of the contrast agent in the bladder unreliable

Lack of health insurance

Patients under legal protection.

Trial design

Treatments tested in this trial

  • Glomerular Filtration Rate measurement with iohexol clearance

Treatment groups

70 Participants
are divided into 1 treatment group