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Eur Radiol. 2013 May;23(5):1250-9. doi: 10.1007/s00330-012-2705-x. Epub 2012 Dec 5.

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

Author information

1
Department of Nephrology, Pitié Salpétrière Hospital, Bat G. Cordier, 47-83 Bd de l'hôpital, 75651 Paris cedex 13, France. gilbert.deray@psl.ap-hop-paris.fr

Abstract

OBJECTIVE:

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.

METHODS:

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 μmol/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.

RESULTS:

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 [Δ = -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.

CONCLUSION:

Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD.

KEY POINTS:

• 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.

PMID:
23212275
PMCID:
PMC3622739
DOI:
10.1007/s00330-012-2705-x
[Indexed for MEDLINE]
Free PMC Article

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