Using Highly Concentrated Gadobutrol as an MR Contrast Agent in Patients Also Requiring Hemodialysis (original) (raw)
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European radiology, 2016
To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting. GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events. Median gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutr...
Decreased native renal T 1 up to one week after gadobutrol administration in healthy volunteers
Journal of Magnetic Resonance Imaging, 2019
Background: Gadolinium-based contrast agents (GBCAs) are widely used in MRI, despite safety concerns regarding deposition in brain and other organs. In animal studies gadolinium was detected for weeks after administration in the kidneys, but this has not yet been demonstrated in humans. Purpose: To find evidence for the prolonged presence of gadobutrol in the kidneys in healthy volunteers. Study Type: Combined retrospective and prospective analysis of a repeatability study. Population: Twenty-three healthy volunteers with normal renal function (12 women, age range 40-76 years), of whom 21 were used for analysis. Field Strength/Sequence: Inversion recovery-based T 1 map at 3T. Assessment: T 1 maps were obtained twice with a median interval of 7 (range: 4-16) days. The T 1 difference (ΔT 1) between both scans was compared between the gadolinium group (n = 16, 0.05 mmol/kg gadobutrol administered after T 1 mapping during both scan sessions) and the control group (n = 5, no gadobutrol). T 1 maps were analyzed separately for cortex and medulla. Statistical Tests: Mann-Whitney U-tests to detect differences in ΔT 1 between groups and linear regression to relate time between scans and estimated glomerular filtration rate (eGFR) to ΔT 1. Results: ΔT 1 differed significantly between the gadolinium and control group: median ΔT 1 cortex-98 vs. 7 msec (P < 0.001) and medulla-68 msec vs. 19 msec (P = 0.001), respectively. The bias corresponds to renal gadobutrol concentrations of 8 nmol/g tissue (cortex) and 4 nmol/g tissue (medulla), ie,~2.4 μmol for both kidneys (0.05% of original dose). ΔT 1 correlated in the gadolinium group with duration between acquisitions for both cortex (regression coefficient (β) 16.5 msec/day, R 2 0.50, P < 0.001) and medulla (β 11.5 msec/day, R 2 0.32, P < 0.001). Medullary ΔT 1 correlated with eGFR (β 1.13 msec/(ml/min) R 2 0.25, P = 0.008). Data Conclusion: We found evidence of delayed renal gadobutrol excretion after a single contrast agent administration in subjects with normal renal function. Even within this healthy population, elimination delay increased with decreasing kidney function. Level of Evidence: 3 Technical Efficacy: Stage 3
A Comparison of Low-Dose and Normal-Dose Gadobutrol in MR Renography and Renal Angiography
Korean Journal of Radiology, 2008
Objective: It has been advocated that a reduced injection volume with highly concentrated (1 M) contrast material can produce a sharper bolus peak and an increased intravascular first-pass gadolinium concentration when compared with the use of a lower concentration (0.5 M). A higher concentration would also cause a reduction in dose. The purpose of our study was to test the use of a low dose (0.05 mmol/kg) of gadobutrol in magnetic resonance renography and angiography and compare the findings with a dose of 0.1 mmol/kg.
The Use of Gadolinium for Arterial Interventions
Annals of Vascular Surgery, 2011
Background: Gadolinium (Gd) has been traditionally used as a non-nephrotoxic alternative to iodinated contrast for digital subtraction angiography (DSA) in patients with chronic renal insufficiency. However, its use has been questioned on the basis of reports of nephrotoxicity and its recent association with nephrogenic systemic fibrosis (NSF), a potentially lethal complication. Recently available data are conflicting with respect to the true safety profile of intra-arterial Gd. The purpose of this study was to examine the risk of contrast nephropathy and NSF after Gd exposure in a large population of azotemic patients undergoing DSA. Methods: A comprehensive database encompassing data on all patients who underwent DSA between June 2003 and December 2007 at the New York Presbyterian Hospital was retrospectively reviewed. Patients receiving Gd either alone or in combination with iodinated contrast during DSA were identified and further analyzed. Acute renal failure (ARF) was defined as an elevation in serum creatinine (Cr) by >0.5 mg/dL within 48 hours of exposure. Clinical followup was conducted through chart reviewing as well as telephonic interviews with patients and their primary care physicians. Results: A total of 153 patients underwent 179 exposures to Gd either alone (33%) or in combination (67%) with iodinated contrast. Mean follow-up duration was 27.1 months. The mean Cr level was 1.94 ± 0.78 mg/dL and 1.96 ± 1.1 mg/dL before and after DSA, respectively. There were 20 (11.2%) instances of ARF. The mean Cr level before DSA was higher in patients who developed ARF versus those in the non-ARF group (2.7 ± 1.1 mg/dL vs. 1.9 ± 0.7 mg/dL, p ¼ 0.004). In the ARF group, 12 patients had a return to baseline renal function, four experienced irreversible renal deterioration, and four needed dialysis (4.5% incidence of irreversible renal failure). There were 19 deaths at the time of this study (12.4%). The highest risk for the development of ARF after Gd exposure occurred in patients with Cr levels of >3.0 mg/dL before DSA and in those receiving >0.4 mmol/kg of Gd. For patients who received iodinated contrast in combination with Gd, there was a trend toward a higher risk for developing ARF as compared with those receiving only Gd. Finally, there were no instances of NSF identified in any of the patients who received intra-arterial Gd. Conclusions: Although Gd has the potential to cause kidney injury similar to iodinated contrast, the risk of irreversible renal failure and the requirement for dialysis is low. Life-or limbthreatening interventions should not be avoided in this patient cohort because of preexisting elevations in Cr. These data should help guide the use of Gd in patients with chronic renal insufficiency.
Gadobutrol in India—A Comprehensive Review of Safety and Efficacy
Magnetic Resonance Insights
Gadobutrol is a gadolinium (Gd)-based contrast agent for magnetic resonance imaging (MRI). In India, gadobutrol is approved for MRI of the central nervous system (CNS), liver, kidneys, breast and for MR angiography for patients 2 years and older. The standard dose for all age groups is 0.1 mmol/kg body weight. The safety profile has been demonstrated in 42 clinical phase 2 to 4 studies (>6800 patients), 7 observational studies, and by assessing pharmacovigilance data of 29 million applications. Furthermore, studies in children, adults, and elderly and in patients with impaired liver or kidney function did not show any increased adverse event rate. Diagnostic efficacy was demonstrated in numerous studies and various indications, such as diseases of the CNS, peripheral and supra-aortic vessels, kidneys, liver, and breast.
Nanomedicine: Nanotechnology, Biology and Medicine, 2010
Many forms of organocomplexed gadolinium (Gd) contrast agents have recently been linked to a debilitating and a potentially fatal skin disease called nephrogenic systemic fibrosis (NSF) in patients with renal failure. Free Gd released from these complexes via transmetallation is believed to be the most important trigger for NSF. In this work, nanostructure silica materials that have been functionalized with 1-hydroxy-2-pyridinone (1,2-HOPO-SAMMS) have been evaluated for selective and effective removal of both free and chelated Gd (gadopentetate dimeglumine and gadodiamide) from dialysate and blood. 1,2-HOPO SAMMS has high affinity, rapid removal rate, and large sorption capacity for both free and chelated Gd, properties that are far superior to those of activated carbon and zirconium phosphate currently used in the state-of-the-art sorbent dialysis and hemoperfusion systems. The SAMMS-based sorbent dialysis and hemoperfusion will potentially provide an effective and predicable strategy for removing the Gd from patients with impaired renal function after Gd exposure, thus allowing for the continued use of Gd-based contrast magnetic resonance imaging while removing the risk of NSF. From the Clinical Editor: Chelated gadolinium (Gd) contrast agents have been linked to a debilitating disease called nephrogenic systemic fibrosis (NSF) in patients with renal failure. Free Gd+ 3 released from the contrast agents is believed to be the trigger for NSF. In this work, functionalized nanostructured silica materials were evaluated for removal of both free and chelated gadolinium both from dialysate and blood. The new method demonstrated a rapid removal rate and large sorption capacity, and overall was far superior to currently used state-of-the-art sorbent dialysis and hemoperfusion systems.
Nephrology Dialysis Transplantation, 2004
To determine whether gadolinium-based contrast media (CM) could be used safely for angiographies in patients with renal dysfunction we investigated renal function after gadobutrol exposure and compared the results with standard iodinated CM (iohexol) in a randomized clinical study. Methods. Twenty-one patients (aged 67±11 years, nine female and 12 male) with severely impaired renal function [mean serum creatinine 3.2±1.3 mg/dl, mean glomerular filtration rate (GFR) 31±16 ml/ min/1.73 m 2 ] who needed to have angiography because of severe peripheral vascular disease, renal artery stenosis or aortic aneurysms were randomized to receive in a blinded manner either gadobutrol (Gadovist Õ 1.0 mmol/ml) or iohexol (Omnipaque Õ 350) as contrast agents. GFR was measured by CM clearance (Renalyzer Õ ) at baseline and 48 h after CM administration. The primary end point was the mean change of GFR from baseline at 48 h, the secondary one the incidence of CM-induced acute renal failure, defined as a decrease in GFR of >50% from baseline within 48 h of CM administration. Results. In the gadobutrol group (n ¼ 10) we observed a statistically significant decrease in GFR of 10.6± 13.8 ml/min/1.73 m 2 within 48 h after CM administration (P<0.05, paired t test). The incidence of CMinduced ARF amounted to 50%. In comparison, the iohexol group (n ¼ 11) also showed a statistically significant GFR reduction of 8.7±8.8 ml/min/1.73 m 2 (P<0.05, paired t test), and of ARF by 45%. The percentile of differences of GFR decreases between the two groups was not significant (P ¼ 0.70). No patient demonstrated other adverse effects of gadobutrol or iohexol administration, apart from GFR reduction.