The Relationship Between IRRIV and RFR Under Pathologic Conditions

Acute Kidney Injury Clinical Trial

— IRRIV-RFR  

Official title:

The Relationship Between IRRIV and RFR Under Pathologic Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756376
• Other study ID #: 35/14
• Status: Completed
• Start date: September 2, 2015
• Est. completion date: January 13, 2016

Study information

• Verified date: November 2018
• Source: Ospedale San Bortolo di Vicenza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 13, 2016
• Est. primary completion date: November 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Bortolo di Vicenza

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between IRRIV test and RFR in cardiac surgery patients	IRRIV test and RFR will be determined and a relationship will be assessed	Change from baseline to 60 minutes
Secondary	Concordance between IRRIV test and RFR in cardiac surgery patients	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

External Links

•   SSamoni ppt