The Relationship Between IRRIV and RFR Under Pathologic Conditions

NCT ID: NCT03756376

Last Updated: 2018-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-02

Study Completion Date

2016-01-13

Brief Summary

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The assessment of renal functional reserve (RFR) has been proposed for the risk stratification of patients undergoing potentially nephrotoxic procedures. The present pilot study is designed to explore the correlation between IRRIV and RFR under pathologic conditions.

Detailed Description

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Renal functional reserve (RFR) represents the capacity of the kidney to increase glomerular filtration rate (GFR) in response to certain physiological or pathological stimuli or conditions.

RFR 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. Recently, 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.The present pilot study is designed to explore the correlation between IRRIV and RFR under pathologic conditions.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IRRIV and RFR

Enrolled patients will receive IRRIV test and RFR assessment. RFR will be evaluated through a protein loading test. (1.2 g of protein/Kg of body weight) performed with cooked beef. The RFR was then defined as the difference between the highest CrCl obtained after the protein load and the baseline CrCl measured on rest conditions. Concerning the IRRIV test, a weight of 10% of the patient's body weight is applied on the abdominal wall. RRIs is recorded in a middle interlobular artery, every minute for 10 minutes during the echo-renal stress test. The lowest RRI reached is taken as reference (stress RRI). The IRRIV is defined as the percentage difference between baseline RRI and stress RRI

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Estimated GFR (CKD-EPI) greater than or equal to 60 mL/min/1.73 m2
* Scheduled cardiac surgery with cardiopulmonary bypass (coronary artery bypass, valve replacements, combined or other operations).

Exclusion Criteria

* Age less than 18 years old
* Pregnancy
* Ultrasound evidence of morphological kidney abnormalities and/or renal artery stenosis
* Nonsteroidal anti-inflammatory drugs (NSAIDs)
* Contrast media in the 2 days before the tests.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Bortolo di Vicenza

OTHER

Sponsor Role lead

Responsible Party

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Sara Samoni

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Ronco

Role: STUDY_DIRECTOR

Ospedale San Bortolo di Vicenza

References

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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.

Reference Type RESULT
PMID: 27458386 (View on PubMed)

Related Links

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Other Identifiers

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35/14

Identifier Type: -

Identifier Source: org_study_id

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