Jun 12, · Purpose of review: Use of gadolinium-based contrast agents (GBCA) in renal impairment is controversial, with physician and patient apprehension in acute kidney injury (AKI), chronic kidney disease (CKD), and dialysis because of concerns regarding nephrogenic systemic fibrosis (NSF) Kidney stone disease, also known as nephrolithiasis or urolithiasis, is when a solid piece of material (kidney stone) develops in the urinary tract. Kidney stones typically form in the kidney and leave the body in the urine stream. A small stone may pass without causing symptoms. If a stone grows to more than 5 millimeters ( in), it can cause blockage of the ureter, resulting in sharp and Feb 22, · Douglas C, Murtagh FE, Chambers EJ, et al. Symptom management for the adult patient dying with advanced chronic kidney disease: a review of the literature and development of evidence-based guidelines by a United Kingdom Expert Consensus Group. Palliat Med. ; 23 (2) [Google Scholar]
Kidney stone disease - Wikipedia
Try out PMC Labs and tell us what you think. Learn More, literature review kidney disease. Language: English French. Use of gadolinium-based contrast agents GBCA in renal impairment is controversial, with physician and patient apprehension in acute kidney injury AKIchronic kidney disease CKDand dialysis because of concerns regarding nephrogenic systemic fibrosis NSF. This review and clinical practice guideline addresses the discrepancy between existing Canadian guidelines regarding use of GBCA in renal impairment and NSF.
Published literature including clinical trials, retrospective cohort series, review articles, literature review kidney disease, and case reportsonline registries, literature review kidney disease, and direct manufacturer databases were searched for reported cases of NSF by class and specific GBCA and exposed patient population. A comprehensive review was conducted identifying cases of NSF and their association to class of GBCA, specific GBCA used, patient, and dose when this information was available.
Based on the available literature, consensus guidelines were developed by an expert panel of radiologists and nephrologists. Standard GBCA dosing should be used; half or quarter dosing is not recommended and repeat injections should be avoided.
Dialysis-dependent patients should receive dialysis; however, initiating dialysis or switching from peritoneal to hemodialysis to reduce literature review kidney disease risk of NSF is unproven. Use of a macrocyclic ionic instead of macrocyclic nonionic GBCA or macrocyclic instead of newer linear GBCA to further prevent NSF is unproven.
Gadopentetate dimeglumine, gadodiamide, and gadoversetamide remain absolutely contraindicated in patients with AKI, those with category G4 or G5 CKD, or those on dialysis. The panel agreed that screening for renal disease is important but less critical when using macrocyclic and newer linear GBCA. Monitoring for and reporting of potential cases of NSF in patients with AKI or CKD who have received GBCA is recommended.
Limited available literature number of injections and use in renal impairment regarding the use of gadoxetate disodium. Limited, but growing and generally high-quality, number of clinical trials evaluating GBCA administration in renal impairment.
Limited data regarding the topic of Gadolinium deposition in the brain, particularly as it related to patients with renal impairment. Les patients dépendants de la literature review kidney disease devraient poursuivre leur traitement.
NSF is strongly associated with administration of GBCA in patients with category G4 or G5 CKD or on dialysis. Avoidance of GBCA in patients with renal impairment may be unnecessary due to important differences in incidence of NSF with macrocyclic and newer linear GBCA.
This guideline acknowledges that NSF is exceedingly uncommon literature review kidney disease macrocyclic or newer linear GBCA are used in patients with category G4 or G5 CKD improves access to GBCA-enhanced MRI when medically necessary and in immediate and anticipated reductions in outpatient screening of renal function prior to GBCA-enhanced MRI.
Gadolinium-based contrast agents GBCA have been in clinical use for decades and have an integral role in magnetic resonance imaging MRI examinations, literature review kidney disease. In general, GBCA have an excellent safety profile 1 - 7 ; however, they have been identified as the causative agent in literature review kidney disease systemic fibrosis NSF. To address a disparity in Canadian guidelines regarding NSF and more recent literature evaluating NSF in macrocyclic and newer linear ionic agents, updated guidelines were developed by a joint working group involving members of the Canadian Association of Radiology CAR and the Canadian Society of Nephrology CSN.
The purpose of these guidelines was not to exhaustively review the mechanisms of NSF, or the biochemistry of gadolinium chelates in general, or to address the recently-described phenomenon of gadolinium deposition in the brain which is being reviewed with guidelines formulated by a separate working group commissioned by the CAR ; however, these concepts were considered and are addressed briefly herein.
Data on the risk of GBCA allergic adverse events are not reviewed and are beyond the scope of this guideline but have been described elsewhere. GBCAs have been used in conjunction with MRI since the s and have an overall excellent cumulative safety record, literature review kidney disease.
GBCAs are derived and administered in a chelated form to minimize the amount of free gadolinium in the body. Although the overall stability of a given GBCA is unique for each molecular structure and other factors that may influence stability that are beyond the scope of this article, 17 in general a macrocyclic structure confers greater stability than a linear structure, literature review kidney disease, and to a lesser extent, ionic GBCAs have greater stability than nonionic structure.
NSF is a serious late adverse reaction associated with exposure to GBCAs that can occur in patients with literature review kidney disease renal impairment and for which there is currently no known specific or consistently effective treatment. Acute kidney injury is also considered a risk factor for NSF, literature review kidney disease. Risk for NSF is also generally considered to be related to the molecular structure and stability of the GBCA used, literature review kidney disease.
The majority of unconfounded cases of NSF that have been reported are associated with 3 GBCAs: gadodiamide, gadopentetate dimeglumine, and gadoversetamide see Table 1 and subsequent sections for a description of different GBCAs currently used clinically.
Structure, literature review kidney disease, Stability, Estimated Number of Global Injections, Number of Confounded and Unconfounded Reports of NSF, Classification by the European Medicines Agency, literature review kidney disease, US Food and Drug Administration FDA and American College of Literature review kidney disease, and Health Canada Guidelines for Patients With Severe Chronic Kidney Disease and Acute Kidney Injury Among Currently Approved Gadolinium-Based Contrast Agents for Clinical Use in Canada.
The incidence of NSF using newer linear and macrocyclic agents has decreased considerably. It is difficult to accurately estimate the prevalence of NSF, but it is now considered a rare entity. There is a long-standing recognition that gadolinium can replace calcium in the hydroxyapatite of bone 19 and more recently, there are increasing concerns about GBCA deposition in the brain.
There are presently 8 GBCA approved for clinical use in Canada 9 ; these are summarized in Figure 1 and Table 1. The following section describes these agents in detail as they pertain to risk of NSF, literature review kidney disease.
The GBCAs are divided into 3 classes: 1 older linear agents associated with the highest number of unconfounded cases of NSF gadodiamide, gadopentetate dimeglumine, and gadoversetamide2 newer linear agents associated with zero unconfounded cases of NSF gadobenate dimeglumine and gadoxetate disodiumand 3 macrocyclic agents associated with an exceedingly low number of unconfounded cases of NSF.
The American College of Radiology ACR manual on contrast media v Depiction of the current gadolinium-based contrast agents approved for clinical use in Canada. Gadodiamide, marketed by GE Healthcare Chicago, Illinois as Omniscan, a linear nonionic GBCA thermodynamic stability of In cases of NSF confounded by the use of multiple agents, when 1 of these 3 agents had been administered 90 confounded cases of NSF with gadodiamide, confounded cases with gadopentetic acid and 11 confounded cases with gadoversetamide 12it is generally assumed that 1 of these agents was likely the causative GBCA which led to the development of disease, although it is not possible to prove which agent was ultimately responsible for causing NSF when multiple agents had been administered to the same patient.
These agents are considered as high risk for causing Literature review kidney disease in at-risk populations by the European Medicines Agency 11 and categorized as Class I agents by the American College of Radiology Manual on Contrast Media v Gadobenate dimeglumine, marketed as MultiHance by Bracco Pharmaceuticals Milan, Italyis a linear, ionic contrast agent.
Gadobenate dimeglumine has a thermodynamic stability constant of According to a literature review performed by Bracco Pharmaceuticals, as of 31 Octoberthere are no medically confirmed, unconfounded cases of NSF following the sole administration of gadobenate dimeglumine. This document reports 32 confounded cases of NSF that arose following the administration of MultiHance and other GBCA, most often gadodiamide and gadopentetate dimeglumine.
There are no known confounded cases of NSF where a patient received only gadobenate dimeglumine and gadoteridol in combination. Gadoxetate disodium marketed as Primovist in Europe and Canada and Eovist in the United States; Bayer Pharmaceuticals is a linear ionic GBCA 39 distributed in Canada sinceafter receiving approval from Health Canada.
The thermodynamic stability constant of gadoxetate disodium is The number of studies assessing the safety of gadoxetate disodium is very limited. In a prospective multicenter study, literature review kidney disease, in renally impaired patients scheduled for a liver imaging examination, Lauenstein et al reported no NSF events in 85 patients with category G4 or G5 CKD, including 39 on dialysis, who received gadoxetate disodium at full dose 0.
With the half-dose MRI, there was reduced hepatic enhancement in all but the arterial phase; however, there was no difference in diagnostic quality between the 2 doses or in any cases of NSF. Literature review kidney disease no unconfounded or confounded cases of NSF have been reported using gadoxetate disodium, a literature review kidney disease to evaluating its safety profile with respect to NSF is that, as a newer agent with specific indications, there have been substantially fewer injections of gadoxetate disodium as compared with other GBCAs.
The use of gadoxetate disodium in clinical practice is generally restricted to the assessment of colorectal cancer liver metastases CRCLMdifferentiating hepatic focal nodular hyperplasia FNH from hepatocellular adenoma HCAand evaluating for biliary leaks. CRCLM detection is particularly crucial for surgical planning ie, metastasectomyand although alternative studies contrast-enhanced computed tomography [CT] and positron emission tomography [PET] are available, there is a higher detection rate using gadoxetate disodium—enhanced MRI compared with both CT and PET.
Therefore, a clinical situation where gadoxetate disodium is required to evaluate for FNH versus HCA in AKI or severe renal impairment is unlikely. The use of gadoxetate disodium in cirrhotic patients for diagnosis of hepatocellular carcinoma is under active investigation and not currently considered the reference standard compared with extracellular GBCAs.
Gadoterate meglumine, marketed as Dotarem by Guerbet Pharmaceuticals Villepinte, France is a macrocyclic, ionic agent. It is classified as a group II agent by the FDA, who approved it in 55 and by the ACR.
The vast majority of events involving gadoterate meglumine are summarized in a article reviewing data from clinical study and patient safety databases, as well as postmarketing safety studies. Upon further review, only 7 of these cases were deemed confirmed or consistent with NSF, and these were all confounded cases.
Other important studies evaluating the safety of gadoterate meglumine with respect to NSF are summarized in Appendix C. Gadoteridol marketed as ProHance; Bracco Pharmaceuticals is a macrocyclic, nonionic agent, which was first approved by the FDA in and later by Health Canada in Currently, it is the only agent approved by the FDA for a cumulative dose of 0, literature review kidney disease. As ofa literature review of regulatory databases literature review kidney disease 22 of histologically proven cases of NSF with either gadobenate dimeglumine or gadoteridol; however, all 22 cases involving these agents were confounded.
A different study cites that multiagent NSF cases involving gadoteridol were confounded by prior administration of either gadodiamide or gadopentetate dimglumine 61 ; however, it is unclear whether the patients from the latter study were included in the literature literature review kidney disease. A review from identified only 2 unconfounded cases of NSF with gadoteridol; however, we could not find the source for this to confirm.
There have been both retrospective and prospective, multicenter studies focused on gadoteridol use in relation to CKD and NSF development. Even with some patients receiving higher doses for magnetic resonance angiography studies, there have been no reports of NSF developing within 2 years of observation post-injection for patients with category G CKD.
Gadobutrol, marketed by Bayer Healthcare Pharmaceuticals Berlin, Germany as Gadovist a macrocyclic, nonionic GBCA was approved by Health Canada in and by the FDA in It is classified as a group II by the ACR 38 and has a thermodynamic stability constant of Several clinical trials and postmarketing surveillance studies have indicated that gadobutrol is well-tolerated among diverse patient populations.
As of Decembermore than 5. One patient when first exposed to gadobutrol apparently had category G3 CKD limitations pertaining to the reported stage of renal disease in this literature review kidney disease are discussed in the guideline section of the article ; another had insulin-dependent diabetes and was on hemodialysis when exposed to gadobutrol, 72 and the third patient had end-stage renal failure when exposed to gadobutrol for literature review kidney disease first time, 73 although it is unclear whether this was a true case of NSF.
Similar to other studies, no incidences of NSF were reported. The documented increased risk for development of NSF following GBCA administration in patients with AKI, with severe CKD, and on dialysis 247677 makes screening for renal disease important prior to GBCA administration.
Traditionally, screening for renal dysfunction prior to GBCA administration was considered of paramount importance to reduce literature review kidney disease incidence of NSF by identifying at-risk patients.
The eGFR, which can be calculated from serum creatinine concentration, age, ethnicity, and gender, is a better measure literature review kidney disease renal function compared with serum creatinine alone, literature review kidney disease.
A questionnaire developed by Choyke et al 88 has been shown to effectively stratify patients by risk of NSF 89 and includes 6 questions Table 2. Choyke et al did not find age to be a significant predictor of renal function. Screening Questionnaire to Be Administered to the Outpatient Population to Identify Renal Disease at Time of MRI Scheduling for Institutions Using Macrocyclic Agents and Newer Linear GBCA and Also Immediately Before MRI for Institutions Which Use Gadodiamide, Gadopentetate Dimeglumine, and Gadoversetamide.
Pregadolinium screening questionnaire for identifying patients at risk of poor renal function, adapted from Choyke et al. Given the exceedingly low risk of NSF when using standard doses of macrocyclic and newer linear GBCA, the panel unanimously favored that in outpatients, screening for renal disease with the questionnaire at literature review kidney disease time of MRI scheduling only when using these agents was sufficient and that it was not necessary to repeat the questionnaire on the day of the test 1363679192 ; however, literature review kidney disease, the patient should be asked again at time of MRI scanning whether they are presently receiving dialysis.
At literature review kidney disease that continue to use high-risk agents gadodiamide, gadopentetate dimeglumine, and gadoversetamide42 the panel suggests using the pregadolinium screening questionnaire both at time of MRI scheduling and immediately prior to MRI scanning to maximize sensitivity for detection of renal impairment.
The panel suggests obtaining a serum creatinine, if literature review kidney disease available or older than 3 to 6 months from the date of administration of the screening questionnaire. For inpatients, literature review kidney disease, the panel endorses what has been recommended by the ACR, namely obtaining an eGFR within 48 hours of anticipated GBCA-enhanced MRI. Several helpful clinical tools include the Acute Kidney Injury Network AKIN and Kidney Disease Improving Global Outcomes KDIGO criteria.
For institutions using macrocyclic literature review kidney disease and newer linear GBCA, we do not consider screening with the questionnaire at time of MRI scheduling to be particularly onerous and plan to revisit the need for routine outpatient screening when reevaluating the guideline at our next audit. In conclusion, this document reviews the relevant literature review kidney disease regarding NSF in literature review kidney disease era of increased physician and patient awareness of disease and associated risk factors eg, literature review kidney disease, renal impairment, increased and repeated dosing of GBCA, and dialysis and specifically reevaluates the role of GBCA-enhanced MRI using newer macrocyclic and linear agents.
Guidelines were developed by a panel of radiologists representing the CAR and nephrologist members of the CSN based on the best available evidence and may provide a framework for use of GBCA in renal impairment in clinical practices in Canada. In summary, the risk of developing NSF in patients with AKI, with severe CKD, and on dialysis when macrocyclic or newer linear GBCAs are used is exceedingly low when standard dosages are prescribed and short-term repeat injections are avoided.
We recommend screening for renal impairment with the 6-question Choyke questionnaire at time of MRI scheduling in facilities using macrocyclic and newer linear agents and also advise that the questionnaire should be repeated at time of MRI for facilities using gadodiamide, literature review kidney disease, gadopentetate dimeglumine, and gadoversetamide.
In patients with AKI or severe CKD, alternate diagnostic tests should be considered first; however, if GBCA-enhanced MRI is considered medically necessary, it can be performed using macrocyclic or newer linear agents; gadodiamide, gadopentetate dimeglumine, and gadoversetamide remain absolutely contraindicated. Patient informed consent is recommended and can be obtained by a physician literature review kidney disease their delegate.
Dialysis should only be performed in patients who are already dialysis dependent, and there is no reliable literature review kidney disease to suggest that initiating dialysis, switching from peritoneal to hemodialysis, or altering dialysis regimens reduces the risk of developing NSF.
There is no evidence to suggest patients with mild renal impairment category G2 CKD are at increased risk of Literature review kidney disease, and no special precautions should be taken in these patients.
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Feb 22, · Douglas C, Murtagh FE, Chambers EJ, et al. Symptom management for the adult patient dying with advanced chronic kidney disease: a review of the literature and development of evidence-based guidelines by a United Kingdom Expert Consensus Group. Palliat Med. ; 23 (2) [Google Scholar] Jun 12, · Purpose of review: Use of gadolinium-based contrast agents (GBCA) in renal impairment is controversial, with physician and patient apprehension in acute kidney injury (AKI), chronic kidney disease (CKD), and dialysis because of concerns regarding nephrogenic systemic fibrosis (NSF) Kidney stone disease, also known as nephrolithiasis or urolithiasis, is when a solid piece of material (kidney stone) develops in the urinary tract. Kidney stones typically form in the kidney and leave the body in the urine stream. A small stone may pass without causing symptoms. If a stone grows to more than 5 millimeters ( in), it can cause blockage of the ureter, resulting in sharp and
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