The Relationship Between IRRIV and RFR Under Pathologic Conditions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03756376

Acronym

IRRIV-RFR

Enrollment

Registered

2018-11-28

Start date

2015-09-02

Completion date

2016-01-13

Last updated

2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Concordance between IRRIV test and RFR in cardiac surgery patients	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.

Outcome results