External Validation of IRRIV Test Relationship With Renal Functional Reserve

NCT03756402 | Completed

• 1 other identifier: 0103/15
• Study Type: observational
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between IRRIV test and RFR

  Change from baseline to 60 minutes

Study Arms (1)

Healthy Subjects

All subjects underwent protein loading test and IRRIV test on the same day. The renal resistive index (RRI) measurements were performed by one trained sonographer using a multi-frequency convex probe through a manual RRI calculations. The RRIs were measured on three interlobular arteries (superior, middle and inferior) in each kidney, and expressed as a mean value. RFR was measured using an oral protein loading test and was then defined as the difference between the highest CrCl obtained after the protein load and the baseline CrCl measured on rest conditions. Urinary creatinine and sCr were measured by the enzymatic method (IL testTM Instrumentation(R), Laboratory SpA, Milano, Italy) and by ILab650 (Instrumentation Laboratory, Werfen Group, Barcelona, Spain).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects undergoing a protein loading and IRRIV test evaluation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale San Bortolo di Vicenza: lead

Related 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. 2016 Jul 6;7:286. doi: 10.3389/fphys.2016.00286. eCollection 2016.

  PMID: 27458386 RESULT

Related Links

• PPT SSamomi

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Claudio Ronco, MD

  Ospedale San Bortolo di Vicenza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: September 2, 2015
• Primary Completion: November 30, 2015
• Study Completion: January 10, 2016
• Last Updated: November 29, 2018

Record last verified: 2018-11