The Relationship Between IRRIV and RFR Under Pathologic Conditions

NCT03756376 | Completed

• 1 other identifier: 35/14
• Study Type: observational
• Target: 31
• 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 present pilot study is designed to explore the correlation between IRRIV and RFR under pathologic conditions.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Concordance between IRRIV test and RFR in cardiac surgery patients

  Change from baseline to 60 minutes

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for cardiac surgery with cardiopulmonary bypass (coronary artery bypass, valve replacements, combined or other operations)

You may qualify if:

• 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).

You may not qualify if:

• 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.

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

• SSamoni ppt

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

  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 10, 2015
• Study Completion: January 13, 2016
• Last Updated: November 29, 2018

Record last verified: 2018-11