External Validation of IRRIV Test Relationship With Renal Functional Reserve (IRRIV-RFR)

November 27, 2018 updated by: Sara Samoni, Ospedale San Bortolo di Vicenza

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects undergoing a protein loading and IRRIV test evaluation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Externally validate IRRIV test
Time Frame: 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.
Change from baseline to 60 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between IRRIV test and RFR
Time Frame: 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.
Change from baseline to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ospedale San Bortolo di Vicenza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Claudio Ronco, MD, Ospedale San Bortolo di Vicenza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0103/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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