External Validation of IRRIV Test Relationship With Renal Functional Reserve

Acute Kidney Injury Clinical Trial

— IRRIV-RFR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756402
• Other study ID #: 0103/15
• Status: Completed
• Start date: September 2, 2015
• Est. completion date: January 10, 2016

Study information

• Verified date: November 2018
• Source: Ospedale San Bortolo di Vicenza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 10, 2016
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Bortolo di Vicenza

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Externally validate IRRIV test	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.	Change from baseline to 60 minutes
Secondary	Correlation between IRRIV test and RFR	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.	Change from baseline to 60 minutes

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