External Validation of IRRIV Test Relationship With Renal Functional Reserve

The Relationship Between IRRIV and RFR Under Normal Conditions: External Validation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03756402

Acronym

IRRIV-RFR

Enrollment

Registered

2018-11-28

Start date

2015-09-02

Completion date

2016-01-10

Last updated

2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, ColorDoppler, IRRIV test, Renal functional reserve, Renal resistive index, Ultrasound

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Externally validate IRRIV test	Change from baseline to 60 minutes	A weight of 10% of the patient's body weight was applied on the abdomen. RRIs were recorded in a middle interlobular artery, every minute for 10 minutes during the echo-renal stress test. The lowest RRI reached was taken as reference (stress RRI). The IRRIV was defined as the percentage difference between baseline RRI and stress RRI.

Secondary

Measure	Time frame	Description
Correlation between IRRIV test and RFR	Change from baseline to 60 minutes	Correlation between IRRIV and RFR is tested through a Pearson analysis. Concordance between presence of RFR (i.e. a RFR≥15ml/min/1.73m2) and a positive/uncertain/negative IRRIV is evaluated.

Outcome results