ESUR Guidelines On Contrast Media
ESUR Guidelines On Contrast Media
ESUR Guidelines On Contrast Media
Abstract
Since 1996 the Contrast Media Safety Committee of the European Society of Urogenital Radiology has released 15 guidelines regarding safety in relation to the use of radiographic, ultrasonographic, and magnetic resonance contrast media. The guidelines have been well received by the radiologic community in Europe and all over the world and comprise current standards for good practice at many institutions. The present report is an overview of the work accomplished by the European Society of Urogenital Radiology over the past 8 years. The committee has covered renal and nonrenal adverse events and other aspects of contrast media. Key words: Contrast mediaAdverse reactionsSafety issuesGuidelines
The Contrast Media Safety Committee (CMSC) consists of 12 to 14 members; most are members of the European Society of Urogenital Radiology (ESUR) and experts in the eld of contrast media research. There is also one member from the scientic section of the pharmaceutical companies that produce contrast agents (Bracco, Italy; GE Healthcare Diagnostics, USA; Guerbet, France; and Schering, Germany). Although members of the committee have diverse views, the CMSC works as one group for the benet of patients. The committee also benets from the wealth of knowledge about contrast agents that is available to representatives of the pharmaceutical companies that provide important input to the work of the committee. However, the rule of the CMSC forbids any commercial promotion, and its dealing with all types of contrast agents is based purely on objective analysis, sound scientic data, well-documented clinical experience, and
clinical common sense. Disagreement within the committee is usually rational and without commercial inuence. The work of the committee involves choosing topics of clinical importance regarding the safe use of contrast media and allocating one or two appropriate members of the committee to produce the rst draft of a report after an extensive review of the literature and sometimes the outcome of a survey among members and nonmembers. The chairman and secretary of the committee then meet and harmonize the draft into the standard style of CMSC reports before circulating it to members. The entire committee meets once a year, makes its reports, and reaches a consensus on the guidelines. All contrast media are referred to by generic names, except when the generic name is confusing (ultrasound contrast agents). The agreed-upon guidelines after extensive discussions by the members of the committee are presented by the rst author at the annual meeting of the ESUR for discussions with participants followed by incorporation of important feedback comments. The nal version, after appropriate editing by the chairman, is sent to European Radiology to be considered for publication. A booklet containing only the guidelines is produced and regularly updated for use by radiologists worldwide. In addition, all guidelines are freely available on the home page of the ESUR (www.esur.org). Thus far, 15 guidelines have been produced by the CMSC. The present report offers an overview of these guidelines.
Classication
Adverse events may be classied as renal or nonrenal and they may be acute or delayed (e.g., skin rashes are a delayed nonrenal adverse reaction, whereas nephropathy induced by contrast medium is an acute renal adverse reaction). Other topics in relation to the use of contrast media include extravasation, the use of contrast media during pregnancy or lactation, and the use of contrast media in patients with thyroid disease.
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Radionuclide techniques are preferable [8] but each of these tests is labor intensive and impossible to perform in all patients undergoing contrast-enhanced imaging. Alternatively, renal function can be estimated by using specially derived predictive equations. The most accurate results are obtained with the Cockroft-Gault equation, whereas the most precise formula is the Modification of Diet in Renal Disease study equation [9]. Unfortunately, the predictive capabilities of these formulae are suboptimal for ideal patient care [9]. However, these methods are far superior for assessing renal function compared with a simple serum creatinine measurement. Another alternative is to use cutoff values for serum creatinine as an indicator of several levels of renal impairment. However, the use of cutoff levels (especially low levels) will include several patients with normal renal function and use of the high cutoff levels will exclude patients with renal impairment [10]. Despite the inaccuracies of serum creatinine measurements, it is an adequate measurement for identifying those patients at risk for contrast medium nephropathy because patients with a normal serum creatinine level (<132 lmol/L or 1.5 mg/dL) have almost no risk [7]. A questionnaire designed to elicit a history of renal disorders and additional risk factors for contrast mediuminduced nephropathy may identify patients with normal serum creatinine level in whom blood testing would be unnecessary [11]. However, a questionnaire does not completely exclude the presence of renal insufficiency, but it is practical and cost efficient. Several patients referred from hospital departments have had their serum creatinine determined for other reasons within the previous year and one can glance at these figures.
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contrast medium, and avoiding short intervals ( <48 h) between procedures that require intravascular administration of contrast media. Of all these measurements, extracellular volume expansion and use of low osmolar contrast media have been found systematically to be consistently effective [1, 1417]. Volume expansion can be achieved with an intravenous injection of at least 100 mL/h of 0.9% saline solution starting 4 h before contrast administration and continuing for 24 h afterward [1]. In areas with a hot climate, more fluid should be given. This regime is suitable for patients who do not have congestive heart failure and are not allowed to drink or eat before undergoing an interventional or surgical procedure. If there is no contraindication to oral administration, free fluid intake should be encouraged. At least 500 mL of water or soft drinks before and 2500 mL for 24 h after the procedure is recommended by the CMSC. Recently, it has been suggested that sodium bicarbonate offers better protection than normal saline [18], but the experience is still limited. Concurrent administration of nephrotoxic drugs such as gentamicin and nonsteroid anti-inflammatory drugs should also be avoided. Mannitol and furosemide enhances the risk of nephrotoxicity [14]. Over the years various regimes of pharmacologic manipulation have been suggested to decrease the frequency of contrast mediuminduced nephropathy. The regimes have included (a) calcium channel blockers, which prevent the inux of calcium ions through voltageoperated channels and, hence, cause a vasorelaxing effect in all vascular beds including the kidney, (b) selective dopamine-1 receptor agonist (fenoldopam) that, in contrast to dopamine, increases cortical and medullary blood ows, (c) endothelin antagonists, which play an important role in renal vasculature, (d) nonselective adenosine receptor antagonist theophylline, which also cause vascular dilatation, and (e) acetylcysteine, which is an antioxidant and scavenger of oxygen free radicals. Administration of these drugs has been shown to be effective in preventing contrast mediuminduced nephropathy in some studies and to be without any effect in others. Even the results of several meta-analyses have been conicting. Therefore, for the time being, the CMSC does not recommend any pharmacologic manipulation for routine use in prevention of contrast mediuminduced nephropathy. The CMSC recommends that non-ionic media be used in patients at risk of developing contrast medium induced nephropathy. At this moment it is unclear whether there is a difference in nephrotoxic potential between low osmolar non-ionic monomeric and isoosmolar non-ionic dimeric contrast media. Various studies have reported conicting results. However, it is clear that all contrast media can cause nephropathy in patients with risk factors.
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body CT, a patient weighing 70 kg would receive 120 mmol of the iodinated agent molecule and 360 mmol of iodine. For MRI, this same 70-kg patient would receive 7 mmol of the gadolinium-based agent molecule and 7 mmol of gadolinium [25]. Thus, the number of iodinated contrast agent molecules administered would be almost 17 times that of gadolinium-containing molecules, and the number of iodine atoms administered would be 51 times that of gadolinium. In 3.5% of 195 patients with abnormal preexamination creatinine clearance levels, acute renal failure (anuria) developed after gadolinium-based contrast medium administration; for MR angiography, the incidence was 1.9% and that for digital subtraction angiography was 9.5% [26]. Dialysis was required in three of the seven patients who developed acute renal failure. The doses of gadolinium-diethylenetriamine pentaacetic acid ranged from 0.31 to 0.41 mmol/kg for MR angiography and 0.27 to 0.42 mmol/kg for digital subtraction angiography. Several other studies have reported the nephrotoxic potential of gadolinium-based contrast media [2731]. An experimental study in pigs has indicated the gadoliniumbased contrast media are more nephrotoxic than iodinated contrast media [31]. Thus, the use of gadolinium-based contrast media for radiographic examinations cannot be recommended to avoid nephrotoxicity in patients with renal impairment [25].
request. In an emergency situation, serum creatinine level should always be measured if the delay of the examination causes no harm to the patient. In case of increased serum creatinine levels, one should not (a) administer high osmolar contrast media, (b) administer large doses of contrast media, (c) administer mannitol and diuretics, in particular loop diuretics, (d) perform multiple studies with contrast media within a short period, and (e) continue metformin administration 48 h before contrast administration. It is important to (a) make sure that the patient is well hydrated (give 100 mL orally, e.g., soft drinks, or intravenously, e.g., normal saline, depending on the clinical situation, every hour starting 4 h before to 24 h after contrast administration; in warm areas increase the uid volume), (b) use low or iso-osmolar contrast media, (c) stop administration of nephrotoxic drugs for at least 24 h, and (d) consider alternative imaging techniques that do not require administration of intravascular radiographic contrast media. There is no need to perform hemodialysis right after injection of contrast medium because it does not decrease the risk of contrast mediuminduced nephropathy. For radiographic examinations, gadolinium-based contrast media cannot be recommended to avoid nephrotoxicity. Metformin should be stopped and the contrast study should be delayed for 48 h. Metformin should be restarted only 48 h later after the examination if serum creatinine level is normal.
Conclusion
Serum creatinine level must always be measured no longer than 7 days before administration of iodinated contrast in patients who have renal disease, renal surgery, proteinuria, diabetes mellitus, hypertension, gout, and recent intake of nephrotoxic drugs. Levels should be provided to the radiology department with the imaging
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vious contrast medium reaction, allergy, or bronchial asthma. In a randomized study of 6763 patients, Lasser et al. [33] found that corticosteroid prophylaxis decreases the incidence of all reactions to ionic contrast medium. Katayama et al. [34] reported no beneficial effect of steroid premedication in a group that received non-ionic contrast media. However, patients only received steroids intravenously immediately before contrast medium [35], so that they did not have time (6 h) to take effect. Current opinion as to whether or not corticosteroid prophylaxis should be used with non-ionic agents is divided [3641]. This division was reflected in a survey from the United Kingdom that showed that 55% of responders used corticosteroid prophylaxis and 45% did not [42]. In a survey performed by the ESUR [43], asthma was considered a significant risk factor, but only 48% of responders gave corticosteroid prophylaxis to these patients. Administration of a very short course of steroids is relatively safe and inexpensive but should be avoided in patients with diabetes mellitus, active tuberculosis, or peptic ulcer disease and in the presence of systemic infection [44, 45]. In the United States and Europe, a wide variety of regimes with different dosages is used for giving corticosteroid prophylaxis, if it is given at all [43, 46]. Based on the results of the survey and a review of the literature, the CSMC recommends that non-ionic agents should used in patients with increased risk (previous generalized contrast medium reaction that was moderate, e.g., urticaria, bronchospasm, or moderate hypotension, or severe, e.g., convulsions, severe bronchospasm, pulmonary edema, cardiovascular collapse, asthma, allergy that required medical treatment of an adverse reaction). Resuscitation drugs should be available in the examination room and patients should be observed for 20 to 30 min after contrast medium injection. For extravascular applications of contrast media in high-risk patients, if absorption or leakage into the circulation is possible, one should take the same precautions as for intravascular administration. However, severe adverse reactions may still occur even in patients who receive corticosteroid premedication and low osmolar contrast media [43].
Table 1. First-line emergency drugs and instruments that should be in the examination room Drugs/instruments Oxygen Adrenaline 1:1000 Antihistamine H1 (suitable for injection) Atropine b2-Agonist metered dose inhaler Intravenous fluids, e.g., normal saline or Ringer solution Anticonvulsive drugs (diazepam) Sphygmomanometer One-way mouth breather apparatus
reactions is rare. In patients who have had a previous severe reaction to contrast medium, most radiologists avoid giving intravascular contrast media, if at all possible [43]. If the examination is considered essential, non-ionic contrast media are the agents of choice based on the evidence in the literature that, with non-ionic agents, the risk of reaction is decreased by a factor of 4 to 5 [34]. The potential risks of the procedure should be explained to the patient, and the resuscitation team should be present when the contrast medium is given [43]. The vast majority of patients with severe anaphylactoid-type reactions recover if they are treated quickly and appropriately. Most patients have reactions while they are still in the radiology department, and 94% to 100% of severe and fatal reactions occur within 20 min of injection of contrast medium [49]. The ability to assess and treat the contrast reaction effectively is an essential skill that the radiologist should have and maintain. The firstline drugs and equipment should be readily available in rooms in which contrast material is injected and a list of recommended drugs and equipment is presented in Table 1. Prompt recognition and treatment (Table 2) can be invaluable in blunting an adverse response of a patient to radiographic contrast material and may prevent a reaction from becoming severe or even life threatening. Radiologists and their staff should review treatment protocols regularly so that each can accomplish his or her role efficiently [5054]. Knowledge, training, and preparation are crucial for guaranteeing appropriate and effective treatment if there is an adverse contrast-related event.
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Table 2. Simple guidelines for first line treatment of acute reactions to contrast media Nausea/vomiting Transient: supportive treatment Severe, protracted: appropriate antiemetic drugs should be considered Urticaria Scattered, transient: supportive treatment including observation Scattered, protracted: appropriate H1 antihistamine intramuscularly or intravenously should be considered; drowsiness and/or hypotension may occur Profound: consider adrenaline 1:1000, 0.10.3 mL (0.10.3 mg) intramuscularly in adults, 0.01 mg/kg intramuscularly up to 0.3 maximum in children; repeat as needed Bronchospasm 1. Oxygen by mask (610 L/min) 2. b2-agonist metered dose inhaler (23 deep inhalations) 3. Adrenaline Normal blood pressure Intramuscular: 1:1000, 0.10.3 mL (0.10.3 mg; (use smaller dose in a patient with coronary artery disease or elderly patient) In pediatric patients: 0.01 mg/kg up to 0.3 mg maximum Decreased blood pressure Intramuscular: 1:1000, 0.5 mL (0.5 mg); in pediatric patients: 0.01 mg/kg intramuscularly Laryngeal edema 1. Oxygen by mask (610 L/min) 2. Intramuscular adrenaline 1:1000, 0.5 mL (0.5 mg) for adults; repeat as needed Hypotension Isolated hypotension 1. Elevate patients legs 2. Oxygen by mask (610 L/min) 3. Intravenous fluid: rapidly, normal saline or lactated Ringer solution 4. If unresponsive: adrenaline 1:1000, 0.5 mL (0.5 mg) intramuscularly; repeat as needed Vagal reaction (hypotension and bradycardia) 1. Elevate patients legs 2. Oxygen by mask (610 L/min) 3. Atropine 0.61.0 mg intravenously and repeat if necessary, after 35 min, to 3 mg total (0.04 mg/kg) in adults; pediatric patients: 0.02 mg/kg intravenously (maximum 0.6 mg/dose) and repeat if necessary to 2 mg total 4. Intravenous fluids: rapidly, normal saline or lactated Ringer solution Generalized anaphylactoid reaction 1. Call for resuscitation team 2. Suction airway as needed 3. Elevate patients legs if hypotensive 4. Oxygen by mask (610 L/min) 5. Intramuscular adrenaline 1:1000, 0.5 mL (0.5 mg) in adults and repeat as needed; pediatric patients 0.01 mg/kg to 0.3 mg maximum 6. Intravenous fluids (e.g., normal saline, lactated Ringer) 7. H1 blocker, e.g., diphenhydramine 2550 mg intravenously
itching, skin rash, musculoskeletal pain, and fever. A significant proportion of these reactions is unrelated to the contrast medium. However, allergy-like skin reactions are well-documented side effects of contrast media, with an incidence of approximately 2%. Late reactions appear to be commoner after non-ionic dimers. Most late skin reactions after contrast medium exposure are probably T-cellmediated allergic reactions. Patients at increased risk of late skin reactions are those with a history of previous contrast medium reaction and those on interleukin-2 treatment. Most skin reactions are selflimiting and resolve within a week. Management is symptomatic and similar to the management of other drug-induced skin reactions. The CMSC does not recommend prophylaxis in general, but patients who have had a previous serious late adverse reaction can be given oral steroids. One should tell patients who have had a previous contrast medium reaction or who are on interleukin-2 treatment that a late skin reaction is possible and that they should contact a doctor if they have a problem [55].
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gadolinium-based contrast media given to a lactating mother reach the milk and only a minute proportion entering the babys gut is absorbed. The CMSC considers the very small potential risk associated with absorption of contrast medium is insufcient to warrant stopping breast feeding for 24 h after iodinated or gadolinium contrast agents [58].
Use of iodinated and gadolinium contrast media during pregnancy and lactation
Mutagenic and teratogenic effects have not been described after administration of gadolinium or iodinated contrast media. Free iodide in radiographic contrast medium given to the mother has the potential to depress fetal/neonatal thyroid function. Neonatal thyroid function should be checked during the rst week if iodinated contrast media have been given during pregnancy. The CMSC considers this check mandatory; in many countries it is done routinely as part of neonatal screening. No effect on the fetus has been seen after gadolinium contrast media. Only tiny amounts of iodinated and
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materials because they have also been observed in placebo control groups. Intolerance to some components may occur. It may be dangerous to use them in connection with echocardiography in patients with very severe heart disease. Generalized allergic-like reactions occur rarely. However, ultrasound contrast agents are generally safe. The CMSC recommends that ultrasound scanning time and the acoustic output are kept to the lowest level consistent with obtaining diagnostic information [60]. Adverse reactions should be treated symptomatically (Table 2).
observed with other types of contrast media such as nausea, vomiting, urticaria, rash, and generalized anaphylactoid reactions. Back pain may also occur with superparamagnetic iron oxides. Serious life-threatening reactions are rare. Iron oxides are contraindicated in patients with known allergy or hypersensitivity to parenteral iron or dextran and should be used with caution in patients with hemosiderosis or hemochromatosis because their iron overload may be aggravated. Manganese-based contrast media are contraindicated in patients with known allergy to the preparation, pregnancy, lactation, and severe liver impairment and should used with caution in patients with liver impairment and heart failure. Knowledge about the oral agent and its contraindications are still limited. Gadolinium-based contrast media are contraindicated in patients with known allergy to the preparation, and the agent with high hepatocyte uptake should be used with caution in patients with liver and renal failure and the one with low hepatic uptake in patients with renal failure [71]. References
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