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NCT Number: NCT03756376

The Relationship Between IRRIV and RFR Under Pathologic Conditions

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation between IRRIV test and RFR in cardiac surgery patients

    Time frame: Change from baseline to 60 minutes

    IRRIV test and RFR will be determined and a relationship will be assessed

Secondary outcomes

  1. Concordance between IRRIV test and RFR in cardiac surgery patients

    Time frame: Change from baseline to 60 minutes

    Concordance between presence of RFR (i.e. a RFR≥15ml/min/1.73m2) and a positive/uncertain/negative IRRIV is evaluated.

Sponsors and collaborators

Lead sponsor

Ospedale San Bortolo di Vicenza

Other

Registry information

Acronym: IRRIV-RFR

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 28, 2018
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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