Evidence map›Paper›PMID 27529464›Full record

Trial reportInvestigative radiology2017

Gadobutrol in Renally Impaired Patients: Results of the GRIP Study.

Henrik J Michaely, Manuela Aschauer, Hannes Deutschmann, Georg Bongartz, Matthias Gutberlet, Ramona Woitek, Birgit Ertl-Wagner, Walter Kucharczyk, Renate Hammerstingl, Francesco De Cobelli and 3 more

Abstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Investigative radiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
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  5. Review
  6. Article
  7. Article
  8. Development of Ln(III) Derivatives asInorganic chemistry · 2024
    Article
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  15. Stability of MRI contrast agents in high-energy radiation of a 1.5T MR-Linac.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2021
    Article
  16. Clinical application and technical considerations of TThe British journal of radiology · 2018
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Henrik J MichaelyFrom the *Institute of Clinical Radiology and Nuclear Medicine, University Hospital Mannheim, Mannheim, Germany; †Clinical Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University Graz, Graz, Austria; ‡Department of Radiology and Nuclear Medicine, University of Basel Hospital, Basel, Switzerland; §Department of Diagnostic and Interventional Radiology, University Leipzig-Heart Center, Leipzig, Germany; ∥Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria; ¶Institute for Clinical Radiology, Ludwig-Maximilian University of Munich-Grosshadern Hospital, Munich, Germany; #Department of Medical Imaging, University Health Network and University of Toronto, Toronto, Ontario, Canada; **Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Frankfurt am Main, Germany; ††Department of Radiology Experimental Imaging Center, San Raffaele Hospital, Vita-Salute University, Milan, Italy; ‡‡Bayer Pharmaceuticals, Radiology, Whippany, NJ; §§Bayer Pharma AG, Radiology, Berlin, Germany; and ∥∥Department of Gynecology, Obstetrics, and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.
Manuela Aschauer
Hannes Deutschmann
Georg Bongartz
Matthias Gutberlet
Ramona Woitek
Birgit Ertl-Wagner
Walter Kucharczyk
Renate Hammerstingl
Francesco De Cobelli
Martin Rosenberg
Thomas Balzer
Jan Endrikat

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to assess the potential risk of gadobutrol-enhanced magnetic resonance imaging (MRI) in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF). MATERIALS AND

methodsWe performed a prospective, international, multicenter, open-label study in 55 centers. Patients with moderate to severe renal impairment scheduled for any gadobutrol-enhanced MRI were included. All patients received a single intravenous bolus injection of gadobutrol at a dose of 0.1 mmol/kg body weight. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period.

resultsA total of 908 patients were enrolled, including 586 with moderate and 284 with severe renal impairment who are at highest risk for developing NSF. The mean time since renal disease diagnosis was 1.83 and 5.49 years in the moderate and severe renal impairment cohort, respectively. Overall, 184 patients (20.3%) underwent further contrast-enhanced MRI with other gadolinium-based contrast agents within the 2-year follow-up. No patient developed symptoms conclusive of NSF.

conclusionsNo safety concerns with gadobutrol in patients with moderate to severe renal impairment were identified. There were no NSF cases.

Indexed as

AdultAgedAged, 80 and overContrast MediaFemaleHumansInjections, IntravenousMagnetic Resonance ImagingMaleMiddle AgedNephrogenic Fibrosing DermopathyOrganometallic CompoundsProspective StudiesRenal InsufficiencyYoung AdultContrast MediagadobutrolOrganometallic Compounds

Identifiers

PMID27529464
PMCPMC5145251

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.