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Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study)

(2013) EUROPEAN RADIOLOGY. 23(5). p.1250-1259
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Abstract
To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients. Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 +/- 24 h after the MRI procedure, by at least 25 % or 44.2 mu mol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at -15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 +/- 24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up. Among the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [Delta = -1.4 %, 95%CI = (-7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P = 0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted. Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD. - Contrast-induced nephropathy (CIN) is a potential problem following gadolinium administration for MRI. - Meglumine gadoterate (Gd-DOTA) appears safe, even in patients with chronic kidney disease. - Gd-DOTA only caused a temporary creatinine level increase in 1/70 such patients. - No case or sign of NSF was detected at 3-month follow-up.
Keywords
Gd-DOTA, Gadolinium-based contrast agent-induced nephropathy, Meglumine gadoterate, MRI, Nephrogenic systemic fibrosis, GADOLINIUM-BASED CONTRAST, NEPHROGENIC SYSTEMIC FIBROSIS, CHRONIC RENAL-INSUFFICIENCY, MEDIA, RISK, NEPHROTOXICITY, ANGIOGRAPHY, FAILURE

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MLA
Deray, Gilbert, et al. “Safety of Meglumine Gadoterate (Gd-DOTA)-Enhanced MRI Compared to Unenhanced MRI in Patients with Chronic Kidney Disease (RESCUE Study).” EUROPEAN RADIOLOGY, vol. 23, no. 5, 2013, pp. 1250–59, doi:10.1007/s00330-012-2705-x.
APA
Deray, G., Rouviere, O., Bacigalupo, L., Maes, B., Hannedouche, T., Vrtovsnik, F., … Marti-Bonmati, L. (2013). Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study). EUROPEAN RADIOLOGY, 23(5), 1250–1259. https://doi.org/10.1007/s00330-012-2705-x
Chicago author-date
Deray, Gilbert, Olivier Rouviere, Lorenzo Bacigalupo, Bart Maes, Thierry Hannedouche, François Vrtovsnik, Claire Rigothier, et al. 2013. “Safety of Meglumine Gadoterate (Gd-DOTA)-Enhanced MRI Compared to Unenhanced MRI in Patients with Chronic Kidney Disease (RESCUE Study).” EUROPEAN RADIOLOGY 23 (5): 1250–59. https://doi.org/10.1007/s00330-012-2705-x.
Chicago author-date (all authors)
Deray, Gilbert, Olivier Rouviere, Lorenzo Bacigalupo, Bart Maes, Thierry Hannedouche, François Vrtovsnik, Claire Rigothier, Jean-Marie Billiouw, Paolo Campioni, Joaquin Ferreiros, Daniel Devos, Daniel Alison, François Glowacki, Jean-Jacques Boffa, and Luis Marti-Bonmati. 2013. “Safety of Meglumine Gadoterate (Gd-DOTA)-Enhanced MRI Compared to Unenhanced MRI in Patients with Chronic Kidney Disease (RESCUE Study).” EUROPEAN RADIOLOGY 23 (5): 1250–1259. doi:10.1007/s00330-012-2705-x.
Vancouver
1.
Deray G, Rouviere O, Bacigalupo L, Maes B, Hannedouche T, Vrtovsnik F, et al. Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study). EUROPEAN RADIOLOGY. 2013;23(5):1250–9.
IEEE
[1]
G. Deray et al., “Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study),” EUROPEAN RADIOLOGY, vol. 23, no. 5, pp. 1250–1259, 2013.
@article{3080317,
  abstract     = {{To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients. 
Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 +/- 24 h after the MRI procedure, by at least 25 % or 44.2 mu mol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at -15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 +/- 24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up. 
Among the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [Delta = -1.4 %, 95%CI = (-7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P = 0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted. 
Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD. 
- Contrast-induced nephropathy (CIN) is a potential problem following gadolinium administration for MRI. 
- Meglumine gadoterate (Gd-DOTA) appears safe, even in patients with chronic kidney disease. 
- Gd-DOTA only caused a temporary creatinine level increase in 1/70 such patients. 
- No case or sign of NSF was detected at 3-month follow-up.}},
  author       = {{Deray, Gilbert and Rouviere, Olivier and Bacigalupo, Lorenzo and Maes, Bart and Hannedouche, Thierry and Vrtovsnik, François and Rigothier, Claire and Billiouw, Jean-Marie and Campioni, Paolo and Ferreiros, Joaquin and Devos, Daniel and Alison, Daniel and Glowacki, François and Boffa, Jean-Jacques and Marti-Bonmati, Luis}},
  issn         = {{0938-7994}},
  journal      = {{EUROPEAN RADIOLOGY}},
  keywords     = {{Gd-DOTA,Gadolinium-based contrast agent-induced nephropathy,Meglumine gadoterate,MRI,Nephrogenic systemic fibrosis,GADOLINIUM-BASED CONTRAST,NEPHROGENIC SYSTEMIC FIBROSIS,CHRONIC RENAL-INSUFFICIENCY,MEDIA,RISK,NEPHROTOXICITY,ANGIOGRAPHY,FAILURE}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{1250--1259}},
  title        = {{Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study)}},
  url          = {{http://doi.org/10.1007/s00330-012-2705-x}},
  volume       = {{23}},
  year         = {{2013}},
}

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