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American Journal of Roentgenology

American Journal of Roentgenology

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Published by: Patricia Guzman on Jul 07, 2010
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 AJR:181, December 2003
 his perspective will present allguidelines produced to date by theContrast Media Safety Committeeof the European Society of Urogenital Radiol-ogy, but attention is focused on the use of gad-olinium-based contrast media for radiographyand CT and the use of dialysis to remove con-trast media after injection in patients with end-stage renal failure.
Methods Used by the Committee
 Guidelines can be produced by opinion-based methods, in which a group of expertssimply reach consensus on a protocol, or byevidence-based methods that rely on carefulanalysis of scientific evidence to determinewhich principles should be considered [1, 2].The Contrast Media Safety Committee of theEuropean Society of Urogenital Radiology(ESUR) have used both the so-called Delphiprocess and consensus after review of the liter-ature, as well as a combination of the two. Twomembers of the committee make the firstdrafts independent of the background of thematerial (answers to questionnaire, review of literature). The draft is harmonized into theESUR style by the chairman and the secretaryof the committee before presentation to allmembers. The committee meets and discussesthe text in principle and the guidelines in de-tail. Then the document is presented to the par-ticipants at one of the European Symposia onUrogenital Radiology, after which the finaldocument is released. More than 300 doctorsare involved in the process. An important issueduring the entire process is that the resultingguidelines should be easy to implement indaily practice.
Renal Adverse Reactions
 Contrast medium–induced nephrotoxicity isdefined as an impairment in renal function (anincrease in serum creatinine by > 25% or 0.5mg/dL [44
 mol/L]) occurring within 3 days af-ter the intravascular administration of contrastmedia and the absence of an alternative cause[3]. It is considered an important cause of noso-comial renal failure. Diagnostic and interven-tional procedures using contrast media areperformed with increasing frequency. In addi-tion, the patient population subjected to theseprocedures is progressively older and has morecomorbid conditions [4]. Prevention of this iat-rogenic condition is important to avoid the sub-stantial morbidity and even mortality that cansometimes be associated with contrast me-dium–induced nephrotoxicity. Even a small de-crease in renal function may exacerbate themorbidity and mortality caused by coexistingconditions such as acquired sepsis, bleeding,coma, and respiratory failure that are morefrequent in patients with acute renal failure[5]. Therefore, several measures have beentried to reduce the frequency of contrast me-dium–induced nephropathy. No measure hasyet resulted in avoidance of its occurrence inall patients.Several measures have been recommendedto reduce the incidence of contrast medium–induced nephropathy [6]. They include volumeexpansion; hydration with IV administrationof normal saline solution (NaCl, 0.9%) or ahalf-strength saline solution (NaCl, 0.45%);infusion of mannitol; administration of atrialnatriuretic peptide, loop diuretics, calciumantagonists, theophylline, dopamine, dopa-mine-1 receptor antagonist fenoldopam, andacetylcysteine; use of low-osmolar nonioniccontrast media instead of high-osmolar ioniccontrast media; use of isoosmolar contrast me-dia instead of low-osmolar contrast media; useof gadolinium-based contrast media instead of iodine-based contrast media for radiographyand CT; hemodialysis soon after contrast ad-ministration; injection of a small volume of contrast medium; and avoiding short intervals(< 48 hr) between procedures requiring intra-vascular administration of contrast media.
Guidelines for Contrast Media from the EuropeanSociety of Urogenital Radiology
 Henrik S. Thomsen
 Received April 24, 2003; accepted after revision July 2, 2003.
 Department of Diagnostic Radiology, Copenhagen University Hospital at Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark. Address correspondence to H. S. Thomsen(heth@herlevhosp.kbhamt.dk).
 2003;181:1463–1471 0361–803X/03/1816–1463 © American Roentgen Ray Society
 AJR:181, December 2003
 Of all these measures, extracellular volumeexpansion and the use of low-osmolar contrastmedia have been found to be most systemati-cally effective [3, 7, 8]. Patients with preexist-ing renal impairment or multiple myeloma [9]should receive adequate hydration before con-trast medium administration. This can beachieved with the IV injection of 100 mL/hr of 0.9% saline solution starting 4 hr before con-trast administration and continuing for 24 hrafterward [6]. In a hot climate, more fluidshould be given. This regime is suitable for pa-tients who are not in congestive heart failureand who are not allowed to drink or eat beforeundergoing an interventional or surgical proce-dure. If there is no contraindication to oral ad-ministration, free fluid intake should beencouraged. At least 500 mL of water or softdrinks orally before and 2,500 mL for 24 hr af-ter contrast administration should be recom-mended (Appendix 1). This fluid intake shouldsecure diuresis of at least 1 mL/min in a non-dehydrated patient. In addition, the concurrentadministration of nephrotoxic drugs such asgentamicin and nonsteroidal antiinflammatorydrugs should be avoided.The main factors in the pathophysiology areconsidered to be a reduction in renal perfusioncaused by a direct effect of contrast media onthe kidney and toxic effects on the tubular cells,although the latter effect is controversial [10].Experimental studies have indicated that the en-dogenous vasoactive peptide endothelin mayplay an important role in mediating theseevents. Therefore, it was expected that endothe-lin antagonists [11] would reduce the incidenceof contrast medium–induced nephropathy inman, but a clinical study has shown the oppositeeffect [12]: a nonselective endothelin receptorantagonist and IV hydration exacerbated con-trast medium–induced nephropathy comparedwith hydration alone. A similar discrepancy hasbeen reported with regard to atrial natriureticpeptide [13]. Calcium-channel antagonists andadenosine antagonists are also not advanta-geous. Dopamine protected against contrast-in-duced decrease in renal function in patients withbaseline serum creatinine greater than 1.9 mg/ dL (170
 mol/L) in one study [14], whereas inanother study it conferred no additional benefitcompared with saline solution alone in prevent-ing contrast medium–induced nephropathy[15]; dopamine had a deleterious effect on re-covery. In another study, the administration of 200 mg of theophylline was shown to have apreventive effect [16], but theophylline has sideeffects. Administration of the antioxidant ace-tylcysteine has also been shown both to be ef-fective in preventing contrast medium–inducednephropathy in some studies [17–19] and to bewithout any effect in others [8, 20]. Thedopamine-1 receptor antagonist fenoldopamhas been shown to reduce the incidence of contrast medium–induced nephropathy in pa-tients with baseline serum creatinine greaterthan 2.0 mg/dL (180
 mol/L) with or withoutdiabetes mellitus who are undergoing percuta-neous coronary intervention [21], whereas in arandomized trial it had no effect [8]. It is ap-propriate to conclude that the efficacy of thesedrugs in the prevention of contrast medium–in-duced nephropathy remains debatable. Furtherstudies are required. However, the administra-tion of frusemide and mannitol should beavoided [1, 6, 7].A recent multicenter study included 129 pa-tients who underwent angiography with eitheran isoosmolar dimer or a nonionic monomerafter randomization; those patients had serumcreatinine levels between 1.5 mg/dL (132
 mol/L) and 3.5 mg/dL (308
 mol/L) due todiabetes mellitus [22]. Contrast medium–in-duced nephropathy was seen in only 3% of thepatients after the dimer and in 26% after themonomer. Chalmers and Jackson [23] found,in patients with nephropathy of various causes,a 25% increase in 4% and 10% of patients afteran isoosmolar nonionic dimer or a low-osmolarnonionic monomer, respectively. Taking the his-tory of contrast medium–induced nephropathyinto account, we must await further studies be-fore a definitive conclusion can be reached.There is reason to believe that future studies of the dimer iodixanol will provide conflictingdata [24].
 Prophylactic Hemodialysis
 Hemodialysis and peritoneal dialysissafely remove both iodinated and gadolin-ium-based contrast media [25]. The effective-ness of hemodialysis depends on manyfactors, including blood and dialysate flowrate; permeability of dialysis membrane; du-ration of hemodialysis; and molecular size,protein binding, hydrophilicity, and electriccharge of the contrast medium. Generally,several hemodialysis sessions are needed forremoval of all contrast medium, and at least 3weeks are required for continuous ambula-tory peritoneal dialysis to remove the agentcompletely. The role of hemodialysis in pre-venting contrast medium–induced nephropa-thy is not well defined. The cost of hemodialysis and the associated risks, includ-ing venous cannulation and the possibility of heparin-induced bleeding, could be justifiedonly if hemodialysis prevented contrast me-dium–induced nephropathy.Thirty patients with moderately reduced re-nal function (mean serum creatinine level,2.5 ± 0.15 mg/dL [212 ± 14
 mol/L]) wererandomly assigned to receive either hemodialy-sis for 3 hr starting as soon as possible or no he-modialysis after administration of a nonionicmonomeric contrast medium [26]. All patientswere well hydrated before and after examina-tion by means of the IV infusion of a normalsaline solution. The incidence of contrast me-dium–induced nephropathy in the hemodialy-sis group was 53% and in the control groupwas 40%. The poor efficacy of hemodialysis inpreventing contrast medium–induced nephrop-athy is related to the rapid onset of renal injuryafter the administration of contrast medium[27]. One hundred thirteen patients withchronic renal impairment (serum creatinine >2.5 mg/dL [200
 mol/L]) were randomlyassigned to either hemodialysis or no hemodi-alysis after the injection of nonionic mono-meric contrast media [28]. All patients receivedsaline infusion according to the same protocolas the previous study. The hemodialysis began30–280 min after the radiographic procedure.The incidence of contrast medium–inducednephropathy in the hemodialysis group was24% and in the no-hemodialysis group was16%. No significant difference was seen be-tween the two groups in relation to clinicallyimportant events (stroke, pulmonary edema,myocardial infarction, and death). Hemodialy-sis may cause deterioration of renal functionthrough activation of inflammatory reactionsand the release of vasoactive substances thatmay induce acute hypotension. Thus, the strat-egy of performing hemodialysis immediatelyafter the administration of contrast media in pa-tients with reduced renal function does not di-minish the rate of complications. Relating thetime of the contrast medium injection to the di-alysis schedule is unnecessary (Appendix 2).
 Gadolinium-Containing Contrast Media Instead of Iodinated Contrast Media for Radiography of Patientswith Increased Risk of Contrast Medium–Induced Nephropathy 
 Gadolinium-based contrast agents are knownbe safe and not nephrotoxic in the usual MRIdoses of up to 0.3 mmol/kg body weight. There-fore, it has been suggested that gadolinium-based contrast media could be used in place of iodinated agents for radiologic examinations inpatients with significant renal impairment [29].At the kilovoltage used for digital angiography,the attenuation of X-ray beams by gadoliniumis approximately the same as for iodine. At the
 Guidelines for Contrast Media
 AJR:181, December 2003
 kilovoltage used for CT, the attenuation by gad-olinium is approximately double that of iodine.Therefore, in theory gadolinium could replaceiodine as a radiographic contrast agent. How-ever, the dose requirement for a satisfactory di-agnostic study differs between MRI andradiography because different properties of gad-olinium are being used in the two techniques.The commonly used dose for body CT is 150mL of a 300 mg I/mL (2.38 mmol I/mL) solu-tion. The standard dose for contrast-enhancedMRI is 0.2 mL/kg of body weight of a 0.5mmol/mL gadolinium-based contrast agent. Forbody CT, a patient weighing 70 kg would re-ceive 120 mmol of the iodinated agent moleculeand 360 mmol of iodine. For MRI, this same70-kg patient would receive 7 mmol of the gad-olinium-based agent molecule and 7 mmol of gadolinium [29]. Thus, the number of iodinatedcontrast agent molecules administered would bealmost 17 times that of gadolinium-containingmolecules, and the number of iodine atoms ad-ministered is 51 times that of gadolinium.In a study involving 64 patients who under-went MRI with a gadolinium-based agent and aradiographic examination with an iodinatedagent, the authors concluded that gadoliniumchelates are significantly less nephrotoxic thaniodinated agents [30]. Eleven of the 64 patientshad a significant increase in serum creatininelevel after IV or intraarterial administration of iodine-based contrast media, whereas none hadincreased serum creatinine levels after IV ad-ministration of a gadolinium-based contrastagent. However, the molar doses and concen-trations of the iodine and gadolinium atomswere not comparable. Albrecht and Dawson[31] studied 15 patients receiving 0.3 mmol/ kg of body weight of gadopentetate dimeglu-mine; five underwent abdominal CT, five ab-dominal digital subtraction angiography, andfive excretory urography. Generally, the im-age quality was inferior to that obtained sub-sequently with standard doses of an iodinatedcontrast medium (50–150 mL of a 300 or 350mg I/mL solution).During recent years, gadolinium-based con-trast agents have been used for examinationssuch as CT, excretory urography, digital sub-traction angiography of various parts of thebody (e.g., hepatic, renal, and peripheral arter-ies), endoscopic retrograde cholangiography,cystography, urethrocystography, and retro-grade pyelography, as well as during percuta-neous nephrostomy and biliary tract drainage.Kaufmann et al. [32] examined 14 patientswith abnormal serum creatinine levels who un-derwent digital subtraction vena cavographywith a gadolinium-based contrast agent (amaximum of 0.4 mmol/kg of body weight) forfilter placement, thrombolysis, or diagnosis.Three of the 14 patients had a significant in-crease in serum creatinine (> 0.5 mg/dL [44
 mol/mL]), but there were other potential con-current causes that might account for the dete-rioration of renal function. Serum creatininetransiently increased from 4.0 to 9.3 mg/dL(350 to 820
 mol/L) after lower extremity ar-teriography with 80 mL of 0.5 mmol/mL (0.44mmol/kg of body weight) of gadoteridol in apatient with diabetic nephropathy [33]. Thedeterioration was thought to most likely be dueto the contrast agent. Thirty-one patients withazotemia or previous severe adverse reactionto iodinated contrast media have undergonedigital subtraction angiography with between20 and 60 mL of 0.5 mmol/mL of gadopen-tetate dimeglumine [34]. In nine cases, CO
 was also used, and in eight cases between 6and 40 mL (mean, 17.8 mL) of iohexol 350mg I/mL was used. In no case did a patient’sserum creatinine level increase more than 0.5mg/dL (44
 mol/L) within 48 hr. In anotherstudy [35], renal function deteriorated in one(6%) of 18 azotemic patients after undergoingCO
 angiography supplemented with 0.5mmol/mL of gadodiamide (20–100 mL; meanvolume, 55 mL; 0.13–0.40 mmol/kg). The af-fected patient received 70 mL of gadodiamide(0.3 mmol/kg of body weight).After injections of 80–440 mL of gadodia-mide during arteriography, the serum creatininelevel increased 0.6 mg/dL (53
 mol/mL) ormore in eight (40%) of 20 patients with a pre-procedural serum creatinine of 1.3–6.3mg/dL(115–548
 mol/mL) [36]. In three of the eightpatients, the creatinine values did not return tothe baseline value. After peripheral gadoliniumarteriography, angioplasty, and stent placement,a patient with renal insufficiency (serum creati-nine level, 3.9 mg/dL [340
 mol/L]) developedacute renal failure and acute pancreatitis [37].Acute pancreatitis has been seen both after in-traarterial [33] and IV [38] injection of a gado-linium-based contrast agent.According to experimental data from thestudy of animals, gadolinium-based contrastmedia have more nephrotoxic potential than io-dinated contrast media in equivalent X-ray at-tenuating doses. For example, in anexperimental model of renal ischemia in pigs,0.5 mmol/mL of 
gadopentetate dimeglumine (3mL/kg of body weight) caused severe impair-ment of renal function; the low-osmolar gadodi-amide caused less deterioration in renalfunction, and the low-osmolar iohexol (3 mL of 190 mg I/mL per kg body weight) caused evenless [39]. Three milliliters per kilogram of bodyweight of iohexol (70 mg I/mL), which for an-giography is isoattenuating with 0.4 mmol/mLof gadopentetate dimeglumine, caused nochange in renal function.Nephrotoxicity of the gadolinium-basedcontrast agents has now been described in bothman and animals when high doses (> 0.3mmol/kg) are used. Use of such doses of thegadolinium agents in patients with impairedrenal function is not recommended. Their usefor radiography and CT is also not an ap-proved indication anywhere in the world. Amajor drawback with using gadolinium-basedcontrast agents for CT or radiography is thatcommercially available contrast media haveonly one gadolinium atom per molecule and alow molar concentration. In comparison,iodinated monomers for radiographic exami-nations contain three iodine atoms per mole-cule and have molar concentration five timesthat of gadolinium in four of the five gadolin-ium-based contrast agents available on themarket. Hence, image quality is generally infe-rior when gadolinium-based contrast mediaare used for radiography. A position statementon the use of gadolinium-based contrast mediafor radiography has been issued in Europe(Appendix 3).
  Metformin-Induced Lactic Acidosis and theIntravascular Administration of Contrast Media
 Biguanide metformin (dimethylbiguanide) isused in patients with non–insulin dependent di-abetes mellitus and was introduced into clinicalpractice in 1957. Approximately 90% of met-formin is eliminated via the kidneys in 24 hr.Renal insufficiency (glomerular filtration rate <70 mL/min, or serum creatinine > 1.6 mg/dL[140
 mol/L]) will lead to retention of thesebiguanides in the tissues and to the potential de-velopment of fatal lactic acidosis [40].Contrast media should be used with care inpatients receiving metformin. Contrast mediacan induce a reduction in renal function lead-ing to retention of metformin that may inducelactic acidosis because the onset of renal injuryafter the administration of contrast medium isquite rapid [27]. However, no conclusive evi-dence exists indicating that the intravascularuse of contrast media precipitates the develop-ment of metformin-induced lactic acidosis inpatients with normal serum creatinine levels(< 1.5 mg/dL [130
 mol/L]). The complica-tion was almost always observed in non–insu-lin dependent diabetic patients with abnormalrenal function before the injection of contrast

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