Acute Kidney InjuryIRRIV-RFRNCT03756402
External Validation of IRRIV Test Relationship With Renal Functional Reserve
An observational study of Acute Kidney Injury, run by Ospedale San Bortolo di Vicenza.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- Type of treatment
- Pill or oral medicine
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2015to 10 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects undergoing a protein loading and IRRIV test evaluation
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, ColorDoppler, IRRIV test, Renal functional reserve, Renal resistive index, Ultrasound
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 60 minutes
Secondary outcomes (1)
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.
Measured: Change from baseline to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start2 Sep 2015
- Primary completion30 Nov 2015
- Study completion10 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Bortolo di Vicenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Samoni, Ospedale San Bortolo di Vicenza
- Investigators
- Claudio Ronco, MD, Study director, Ospedale San Bortolo di Vicenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756402
- Sponsor's protocol ID
- 0103/15
- Acronym
- IRRIV-RFR
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27458386
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between IRRIV and RFR Under Normal Conditions: External Validation
- ClinicalTrials.gov ID
- NCT03756402
- Acronym / sponsor ID
- IRRIV-RFR / 0103/15
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, ColorDoppler, IRRIV test, Renal functional reserve, Renal resistive index, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Ospedale San Bortolo di VicenzaUniversity, hospital or other
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 10 Jan 2016 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects undergoing a protein loading and IRRIV test evaluation
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation between IRRIV test and RFR
Time frame: Change from baseline to 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Results publication: PubMed 27458386Samoni 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.
- PPT SSamomiLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Ronco, MD study director
Ospedale San Bortolo di Vicenza
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Ospedale San Bortolo di Vicenza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Externally validate IRRIV test (time frame: Change from baseline to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03756402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.