Rationale and Objectives
The Food and Drug Administration recommends renal function estimation using laboratory testing for patients at risk for chronically reduced kidney function before the administration of gadolinium-based contrast agents (GBCAs). Point-of-care (POC) estimated glomerular filtration rate (eGFR) testing was added to the pre-magnetic resonance (MR) questionnaire at our institution in June 2008 for all patients undergoing a contrast-enhanced MR exam. This study was done to evaluate the effectiveness of a pre-MR screening questionnaire about kidney disease and to assess POC eGFR detection of additional patients at risk for nephrogenic systemic fibrosis.
Materials and Methods
This retrospective study was approved by our institutional review board and determined to be Health Insurance Portability and Accountability Act compliant. Medical records, laboratory data, and pre-MR questionnaires of all patients who presented for contrast-enhanced MR scans during October 2008 were reviewed. The National Kidney Disease Education Program isotope-dilution mass spectrometry-traceable Modification of Diet in Renal Disease equation was used to calculate eGFRs using the POC creatinine laboratory value, age, race, and gender. Sensitivity and specificity were calculated using 2 × 2 tables, and 95% confidence intervals were calculated with exact binomial confidence intervals.
Results
A total of 1167 individuals presented for contrast-enhanced MR scans. Of 13 individuals on dialysis, 2 did not report renal disease. Of 1154 individuals not on dialysis, 25 had an eGFR <30 mL/min/1.73 m 2 (95% CI 1.41%–3.18%). Of these 25, 13 did and 12 did not report renal disease. The sensitivity of the questionnaire for identifying patients with an eGFR <30 mL/min/1.73 m 2 was 63.2%. POC eGFR estimations identified a prevalence of 2.17% (95% CI: 1.41%–3.18%) of the total individuals not on dialysis, with an eGFR <30 mL/min/1.73 m 2 . Patients who denied kidney dysfunction had a 1.08% (95% CI: 0.56%–1.88%) posttest probability of having an eGFR <30 mL/min/1.73 m 2 .
Conclusions
POC eGFR testing identified a significant number of individuals with renal dysfunction not found by the pre-MR imaging questionnaire alone.
Nephrogenic systemic fibrosis (NSF) was first recognized in 1997 and first reported in the literature in 2000 . NSF is a systemic-fibrosing disorder that may occur days to months following a magnetic resonance (MR) examination with contrast in those with renal dysfunction . Clinically, patients describe swelling and tightening of the skin, which contributes to pain and loss of mobility . Although originally thought to be limited to the skin, the fibrosing process also occurs systemically . Consequently, scarring of internal organs may impair vital function and lead to death . In 2006, its association with gadolinium-based contrast agents (GBCAs) was suggested in the literature . In 2007, the Food and Drug Administration (FDA) requested a boxed warning for GBCAs to include the risk of developing NSF in those with severe kidney insufficiency who receive a GBCA . NSF occurs in patients with end-stage renal disease (ESRD), on dialysis, or with acute kidney injury. The risk associated with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m 2 has been variably reported as 1%–7% after GBCA administration . However, one study by Rydahl and colleagues have shown that the incidence of NSF can be as high as 18% in patients with stage 5 chronic kidney disease in which eGFR <15 mL/min/1.73 m 2 .
In an attempt to avoid new cases of NSF in June 2008, point-of-care (POC) estimated glomerular filtration rate (eGFR) testing was routinely performed at our institution in addition to the existing screening questionnaire for all patients before anticipated contrast-enhanced MRI. Because many hospitals use questionnaires to assess NSF risk , the purpose of this study was to evaluate the effectiveness of our pre-MR imaging screening questionnaire with respect to kidney disease and to determine if POC eGFR testing detects additional patients at risk for NSF. Our hypothesis was that POC eGFR testing will be more sensitive in the detection of renal disease than our pre-MR imaging questionnaire.
Materials and methods
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Table 1
Demographic Characteristics of Study Population
Data Element Number (n = 1168) Percentage (n = 1168) Gender Females 628 53.77 Male 540 46.23 Age (y) 0–19 13 1.11 20–29 76 6.51 30–39 146 12.50 40–49 216 18.49 50–59 248 21.23 60–69 247 21.15 70–79 157 13.44 80–89 56 4.79 90–99 8 0.68 Ethnicity Asian 21 1.80 Black or African American 187 16.01 Declined to answer 68 5.82 Hispanic or Latino 76 6.51 Unable to answer 99 8.48 White or Caucasian 716 61.30 Gadolinium-based contrast agent administered Gadopentetate dimeglumine (Magnevist) 866 74.14 Gadobenate dimeglumine (Multihance) 210 17.98 No contrast agent given 81 6.93
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Results
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Table 2
Estimated Glomerular Filtration Rate (eGFR) and Patient Self-report of Kidney Disease Demographics
Variable Number Percentage Point-of-care eGFR results (mL/min) 0–9 10 0.9 10–19 11 0.9 20–29 17 1.5 30–39 30 2.6 40–49 83 7.1 50–59 124 10.6 >60 892 76.4 Patients with no self-report of kidney disease 1113 95.4 eGFR 0–9 0 0.0 10–19 6 0.5 20–29 8 0.7 30–39 24 2.2 40–49 70 6.3 50–59 118 10.6 >60 887 79.7 Patients with a self-report of kidney disease 54 4.6 eGFR 0–9 10 18.5 10–19 5 9.3 20–29 9 16.7 30–39 6 11.1 40–49 13 24.1 50–59 6 11.1 >60 5 9.3
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Table 3
Dialysis, Estimated Glomerular Filtration Rate (eGFR), and Patient Self-report of Kidney Disease Demographics
Variable Number Percentage On dialysis 13 1.1 Self-reported kidney disease 11 84.6 eGFR values 0–15 11 100.0 15–30 0 0.0 No self-reported kidney disease 2 15.4 eGFR values 0–15 0 0.0 15–30 2 100.0 Not on dialysis 1154 98.9 Self-reported kidney disease 43 3.7 eGFR values 0–14 3 7.0 15–29 10 23.3 30–59 25 58.1 60+ 5 11.6 No self-reported kidney disease 1111 96.3 eGFR values 0–14 2 0.2 15–29 10 0.9 30–59 212 19.1 60+ 887 79.8
Table 4
Effectiveness of Patient Self-report of Renal Function Compared to Estimated Glomerular Filtration Rate (eGFR) Values after Excluding Hemodialysis Patients
Calculation eGFR <60 eGFR <30 eGFR <15 Sensitivity 0.145 0.520 0.600 95% confidence interval 0.105–0.194 0.313–0.722 0.147–0.947 Specificity 0.994 0.973 0.965 95% confidence interval 0.987–0.998 0.962–0.982 0.953–0.975 Positive predictive value 0.884 0.302 0.070 95% confidence interval 0.749–0.961 0.172–0.461 0.015–0.191 Negative predictive value 0.798 0.989 0.998 95% confidence interval 0.774–0.822 0.981–0.994 0.994–0.999
95% confidence intervals calculated at http://statpages.org/confint.html using the exact binomial confidence interval.
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Discussion
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