External Validation of IRRIV Test Relationship With Renal Functional Reserve

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT03756402
• Lead Sponsor: Ospedale San Bortolo di Vicenza

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.

Study Timeline

• Study Start: 2015-09-02
• Primary Completion: 2015-11-30
• Study Completion: 2016-01-10
• Status Verified: 2018-11
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-27
• Study First Posted: 2018-11-28
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.