Clinical trial NCT03756402: External Validation of IRRIV Test Relationship With Renal Functional Reserve
Official title: The Relationship Between IRRIV and RFR Under Normal Conditions: External Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
ColorDoppler
IRRIV test
Renal functional reserve
Renal resistive index
Ultrasound
Lead sponsor: Ospedale San Bortolo di Vicenza
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects undergoing a protein loading and IRRIV test evaluation

Brief summary: The assessment of renal functional reserve (RFR) has been proposed for the risk stratification of patients undergoing potentially nephrotoxic procedures. The investigators hypothesized that there is a correlation between IRRIV and RFR under normal conditions. For this purpose, externally validation of IRRIV test is performed in a validation cohort of healthy subjects.

Detailed description: Normal subjects display a significant capacity to increase in baseline GFR under physiological needs (e.g. pregnancy) or pathological states (e.g. solitary kidney). This capacity is known as renal functional reserve (RFR), and it is calculated as the difference between the measured maximum GFR achieved through a renal stress test and the baseline GFR measured in rest conditions.In clinical practice, the most common renal stress test is performed as a standardized protein loading test. In a pilot study, the investigators demonstrated a significant correlation between RFR and the intra-parenchymal renal resistive index variation (IRRIV) during an echo renal stress test in a cohort of healthy volunteers. IRRIV test has proven to be rapid, safe, bedside and easy to perform and it might represent a preliminary test in screening patients' RFR. For this purpose, externally validation of IRRIV test is performed in a validation cohort of healthy subjects.

Eligibility criteria: Inclusion criteria were:

* Age more than 18 years old;
* Baseline estimated GFR, calculated using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation, greater than or equal to 60 ml/min/1.73 m2.

Exclusion criteria were:

* Age less than 18 years old;
* Comorbidities potentially affecting renal function (i.e. arterial hypertension, diabetes, vasculopathy, etc.;
* Chronic administration of drugs able to modify renal blood flow and/or GFR (angiotensin converting enzyme-inhibitors (ACEI), angiotensin receptor blockers (ARB), calcium channel blockers, loop diuretics etc.);
* Pregnancy;
* Ultrasound evidence of morphological kidney abnormalities and/or renal artery stenosis;
* Nonsteroidal anti-inflammatory drugs (NSAIDs) or contrast media in the 2 days before the tests.

Primary outcomes:
measure: Externally validate IRRIV test
timeFrame: Change from baseline to 60 minutes
Secondary outcomes:
measure: Correlation between IRRIV test and RFR
timeFrame: Change from baseline to 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Ospedale San Bortolo di Vicenza
name: Claudio Ronco, MD
role: STUDY_DIRECTOR
References:
citation: Samoni S, Nalesso F, Meola M, Villa G, De Cal M, De Rosa S, Petrucci I, Brendolan A, Rosner MH, Ronco C. Intra-Parenchymal Renal Resistive Index Variation (IRRIV) Describes Renal Functional Reserve (RFR): Pilot Study in Healthy Volunteers. Front Physiol. 2016 Jul 6;7:286. doi: 10.3389/fphys.2016.00286. eCollection 2016.