Microsoft word - guidelines version 5.0.doc

ESUR-guidelines 2005 Printed: 13-04-2006 Page: 1 of 15 ESUR Guidelines on Contrast Media Version 5.0 Content:
1. Renal adverse reactions
ESUR guidelines
1.1.To avoid contrast medium induced nephrotoxicity
1.2 Determination of serum creatinine
1.3 Dialysis and contrast media administration
1.4 Administration of contrast media to diabetics taking metformin
ESUR Position Statement
1.5. The use of gadolinium–based contrast media for radiographic examinations
2.Non-renal adverse reactions
ESUR Guidelines
2.1. Prevention of generalized contrast medium reactions
2.2. Management of acute adverse reactions to contrast media
2.3. Late adverse reactions to intravascular iodinated contrast media
3.Other reactions to contrast media
ESUR Guidelines
3.1. Prevention and management of extravasation of contrast media
3.2. Effect of iodinated contrast medium on thyroid function in adults
3.3. Pulmonary effects of contrast media
3.4. Contrast media and Catecholamine-producing tumours (phaeochromocytoma and paraganglioma)
3.5. The use of iodinated and gadolinium contrast media during pregnancy and lactation
3.6. Interactions between contrast media and other drugs
3.7. Safety of ultrasound contrast agents
3.8. Safety of MR extra cellular contrast media
3.9. Safety of MR liver specific contrast media
3.10. Safety of Barium contrast media
ESUR Statement
3.11. Effects of iodinated contrast media on blood and endothelium
References
4.1. Publications from the Contrast Media Safety Committee of the European Society of Urogenital
Radiology.
ESUR-guidelines 2005 Printed: 13-04-2006 Page: 2 of 15 1. Renal Adverse reactions

ESUR Guidelines

1.1. To avoid contrast medium induced nephrotoxicity
Definition
Contrast medium nephrotoxicity is a condition in which an impairment in renal function (an increase in serum creatinine by more than 25% or 44µmol/l (0.5 mg/dl)) occurs within 3 days following the intravascular administration of a contrast medium (CM) in the absence of an alternative etiology. Risk factors
• Raised s-creatinine levels, particularly secondary to diabetic • Congestive heart failure • Age over 70 years old • Concurrent administration of nephrotoxic drugs, e.g. non-steroid In patients
• Make sure that the patient is well hydrated [give at least 100 ml (oral (e.g. soft drinks) or intravenous (normal saline) depending risk factor(s)
on the clinical situation) per hour starting 4 hours before to 24 hours after contrast administration – in warm areas increase the fluid volume] • Use low- or iso-osmolar contrast media • Stop administration of nephrotoxic drugs for at least 24 hours. • Consider alternative imaging techniques, which do not require the administration of iodinated contrast media • Give high osmolar contrast media • Administer large doses of contrast media • Administer mannitol and diuretics, particularly loop-diuretics • Perform multiple studies with contrast media within a short At time of referral for a contrast enhanced
The referring clinician should ask the patient for a imaging examination identify patients with
increased probability of abnormal serum
creatinine levels
The answers should be provided to the department of Radiology with the imaging request ESUR-guidelines 2005 Printed: 13-04-2006 Page: 3 of 15 Serum creatinine not older than 6 months should be provided with the imaging request, if available. Non-emergency examinations Look for
• Positive answer to one or more of the above • Known abnormal S-creatinine level at time of • Procedures requiring intraarterial contrast • S-creatinine level must be measured within 7 informed if the serum creatinine level is increased at least 24 hours before the scheduled examination time in order to make the necessary arrangements Emergency examinations
a. In emergency situations serum creatinine b. If the procedure can be deferred without harm to the patient, serum creatinine should be measured. In patients with abnormal serum creatinine
• Consider alternative imaging techniques, which do not require the administration of iodinated contrast media. • Stop administration of nephrotoxic drugs for • Make sure that the patient is well hydrated. • Use low- or iso-osmolar contrast media. 1.3. Dialysis and contrast media administration Patients
Recommendations
On hemodialysis
• Correlation of the time of contrast medium injection with the hemodialysis session is unnecessary. • Extra hemodialysis session for removal of contrast With severely reduced renal
• Please refer to ESUR guidelines to avoid contrast function
medium induced nephrotoxicity (hydration, use small doses of low osmolar contrast media). • Hemodialysis is unnecessary. • In MRI examinations avoid doses more than 0.3 mmol/kg BW of gadolinium-based contrast agents On continuous ambulatory
Examinations using iodinated agents: peritoneal dialysis (CAPD) [all
• To protect residual renal function please refer to ESUR guidelines to avoid contrast medium induced • Hydration should be considered only after careful ESUR-guidelines 2005 Printed: 13-04-2006 Page: 4 of 15 evaluation of fluid balance state of the patient. Examinations using gadolinium agents: • To protect residual renal function use doses up to 0.3 mmol/kg BW of gadolinium-based contrast agents. 1.4. Administration of contrast media to diabetics taking metformin Serum creatinine level should be measured in every diabetic patient treated with biguanides prior to
intravascular administration of contrast media. Low-osmolar contrast media should always be used in
these patients.
Elective studies

a) If the serum creatinine is normal, the radiological examination should be performed and intake of
metformin stopped from the time of the study. The use of metformin should not be resumed for 48 hrs
and should only be restarted if renal function/serum creatinine remains within the normal range.

b) If renal function is abnormal, the metformin should be stopped and the contrast study should be
delayed for 48 hrs. Metformin should only be restarted 48 hrs after contrast medium, if renal
function/serum creatinine is unchanged.
Emergency cases

a) If the serum creatinine is normal, the study may proceed as suggested for elective patients.

b) If the renal function is abnormal (or unknown), the physician should weigh the risks and benefits of
contrast administration. Alternative imaging techniques should be considered. If contrast media
administration is deemed necessary and the following precautions should be implemented:
• Metformin therapy should be stopped.
• The patient should be hydrated (E.g. at least 100 ml per hour of soft drinks or intravenous saline up to 24 hours after contrast medium administration – In warm areas more fluid should be given). • Monitor renal function (serum creatinine), serum lactic acid and pH of blood. • Look for symptoms of lactic acidosis (vomiting, somnolence, nausea, epigastric pain, anorexia, hyperpnea, lethargy, diarrhea and thirst). Blood test results indicative of lactic acidosis: pH < 7.25 and lactic acid > 5 mmol. 1.5 The use of gadolinium-based contrast media for radiographic examinations. Legal position
Gadolinium-based contrast media are not approved for X-ray examinations Uses of gadolinium-based
contrast media for X-ray
ESUR-guidelines 2005 Printed: 13-04-2006 Page: 5 of 15 examinations
• Prior severe generalized adverse reaction to iodinated contrast reported in the literature
• Imminent thyroid treatment with radioactive iodine ESUR position
1. The use of gadolinium based contrast media for radiographic examinations is not recommended to avoid nephrotoxicity in patients with renal impairment since they are more nephrotoxic than iodinated contrast media in equivalent X-ray attenuating doses. 2. The use of gadolinium based contrast medium in approved intravenous doses up to 0.3 mmol/kg B.W. will not give diagnostic radiographic information in most cases. 2.1. Prevention of generalized contrast medium reactions A. Risk factors for reactions
• Previous generalized contrast medium reaction, either moderate (e.g. urticaria, bronchospasm, moderate hypotension) or severe (e.g. convulsions, severe bronchospasm, pulmonary edema, cardiovascular collapse). • Asthma.
• Allergy requiring medical treatment.
B. To reduce the risk of generalized contrast medium reactions

• Use non-ionic agents.
C. Premedication is recommended in high risk patients (defined in A)
• When ionic agents are used.
• When non-ionic agents are used, opinion is divided about the value of premedication.
D. Recommended premedication
Prednisolone 30 mg orally or Methylprednisolone 32 mg orally 12 and 2 hours before contrast medium. Corticosteroids are not effective if given less than 6 hours before contrast medium • Antihistamines H1 and H2 may be used in addition to corticosteroids, but opinion is divided.
E. Remember for all patients
• Have a trolley with resuscitation drugs in the examination room. • Observe patients for 20 to 30 minutes after contrast medium injection. ESUR-guidelines 2005 Printed: 13-04-2006 Page: 6 of 15 F. Extra vascular administration
• When absorption or leakage into the circulation is possible, take the same precautions as for 2.2. Management of acute adverse reactions to contrast media. First line emergency drugs and instruments which should be in the examination room.
Drugs/Instruments
Oxygen
Adrenaline 1:1,000
Antihistamine H1 – suitable for injection
Atropine
β2-agonist metered dose inhaler
I.V. Fluids – normal saline or Ringers solution
Anti-convulsive drugs (diazepam)
Sphygmomanometer
One-way mouth “breather” apparatus
Simple guidelines for first line treatment of acute reactions to contrast media

Nausea/Vomiting
Transient: Supportive treatment
Severe, protracted: Appropriate anti-emetic 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 1:1,000, 0.1-0.3 ml (0.1-0.3 mg) intramuscularly in adults, 0.01 mg/kg
intramuscularly up to 0.3 max. in children. Repeat as needed.
Bronchospasm
1. Oxygen by mask (6-10 l/min)
2. β-2-agonist metered dose inhaler (2-3 deep inhalations)
3. Adrenaline
Intramuscular: 1:1,000, 0.1-0.3 ml (0.1-0.3 mg) [use smaller dose in a patient with coronary artery disease or elderly patient] In paediatric patients: 0.01 mg/kg up to 0.3 mg max. Intramuscular: 1:1,000, 0.5 ml (0.5 mg), (in paediatric patients: 0.01 mg/kg intramuscularly)
Laryngeal edema

ESUR-guidelines 2005 Printed: 13-04-2006 Page: 7 of 15 1. Oxygen by mask (6 – 10 l/min)
2. Intramuscular adrenaline (1:1,000), 0.5 ml (0.5 mg) for adults, repeat as needed.

Hypotension
Isolated hypotension
1. Elevate patient’s legs
2. Oxygen by mask (6-10 l/min)
3. Intravenous fluid: rapidly, normal saline or lactated Ringer’s solution
4. If unresponsive: adrenaline: 1:1,000 , 0.5 ml (0.5 mg) intramuscularly, repeat as needed
Vagal reaction (hypotension and bradycardia)
1. Elevate patient’s legs
2. Oxygen by mask (6-10 l/min)
3. Atropine 0.6-1.0 mg intravenously, repeat if necessary after 3-5 min, to 3 mg total (0.04 mg/kg) in
adults. In paediatric patients give 0.02 mg/kg intravenously (max. 0.6 mg per dose) repeat if necessary to 2 mg total. 4. Intravenous fluids: rapidly, normal saline or lactated Ringer’s solution

Generalized anaphylactoid reaction
1. Call for resuscitation team
2. Suction airway as needed
3. Elevate patient’s legs if hypotensive
4. Oxygen by mask (6 – 10 l/min)
5. Intramuscular adrenaline (1:1,000), 0.5 ml (0.5 mg) in adults. Repeat as needed. In paediatric
patients 0.01 mg/kg to 0.3 mg (max. dose) 6. Intravenous fluids (e.g. normal saline, lactated Ringer’s)
7. H1-blocker e.g. diphenhydramine 25-50 mg intravenously

2.3 Late adverse reactions to intravascular iodinated contrast media
Definition:
A late adverse reaction to intravascular iodinated contrast medium is defined as a reaction which occurs 1 hour to 1 week after contrast medium injection Reactions:
A variety of late symptoms (e.g. nausea, vomiting, headache, musculoskeletal pains, fever) have been described following contrast medium, but many are not related to contrast medium. Skin reactions of similar type to other drug eruptions are true late adverse reactions. They are usually mild to moderate and self-limiting. Risk factors for skin
reactions:
ESUR-guidelines 2005 Printed: 13-04-2006 Page: 8 of 15 Management:
Symptomatic and similar to the management of other drug-induced skin reactions Prophylaxis:
• Patients who have had a previous serious late adverse reaction, can be given oral steroids (see ESUR Guidelines on prevention of generalized adverse reactions). Recommendations:
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
3. Other reactions to contrast media
ESUR Guidelines

3.1.Prevention and management of extravasation of contrast media.
Risk factors relate to:
• use of a power injector. • less optimal injection sites including lower limb and small distal • with arterial insufficiency. • with compromised lymphatic and/or venous drainage. To reduce the risk
• Intravenous technique should always be careful, preferably using Type of injuries
• Most injuries are minor. • Severe injuries include skin ulceration, soft tissue necrosis, and Treatment
• Conservative management is adequate in most cases ¾ limb elevation ¾ apply ice packs ¾ careful monitoring ● If a serious injury is suspected, seek the advice of a surgeon. ESUR-guidelines 2005 Printed: 13-04-2006 Page: 9 of 15
3.2. Effect of iodinated contrast media on thyroid function in adults
Absolute contraindication

• Iodinated contrast media should not be given to patients with manifest Development of thyrotoxicosis after iodinated contrast media
No risk
• Patients with normal thyroid function • Patients with Graves’ disease • Patients with multinodular goiter and thyroid autonomy, especially if they are elderly and/or live in areas of dietary iodine deficiency • Prophylaxis is generally not necessary • Patients at risk should be closely monitored by endocrinologists after • In selected high-risk patients, prophylactic treatment may be given by an endocrinologist; this is more relevant in areas of dietary iodine deficiency • Intravenous cholangiographic contrast media should not be given to Radioactive iodine treatment
Recommendation
• Patients undergoing therapy with radioactive iodine should not have received iodinated contrast media for at least two months before treatment Isotope imaging of the thyroid
Recommendation
• Isotope imaging of the thyroid should be avoided for two months after
3.3. Pulmonary effects of contrast media
High risk patients
• Use low or iso osmolar contrast media 3.4. Contrast media and Catecholamine-producing tumours (phaeochromocytoma and paraganglioma) Tumour localisation when
Characterisation of
catecholamine-producing tumour incidentally detected adrenal
detected bio-chemically
ESUR-guidelines 2005 Printed: 13-04-2006 Page: 10 of 15 3.5. The use of iodinated and gadolinium contrast media during pregnancy and lactation Iodinated agents
Gadolinium agents
Pregnancy
iodinated contrast media may be given to pregnant female. the pregnant female. b) Following administration of iodinated thyroid function should be checked in the necessary. neonate during the first week. Lactation
normally when iodinated agents are given normally when gadolinium agents are to the mother. Pregnant or
lactating
ESUR-guidelines 2005 Printed: 13-04-2006 Page: 11 of 15 mother with
impairment
3.6. Avoiding interaction between contrast media and other drugs Be aware of the patient’s drug history. Keep proper records of the contrast medium injection (time, dose, name) Drugs needing
special attention
Aminoglycosides Non-steroid anti-inflammatory drugs Refer to ESUR guidelines on delayed reactions Avoid contrast medium injection if possible Mix contrast media with other drugs in tubes or syringes Make non emergency biochemical analysis on blood or urine collected within 24 hours of contrast medium injection Isotope studies
Refer to ESUR guidelines on thyroid function in adults Avoid contrast medium injection for at least 3.7. Safety of ultrasound contrast media
Statement:
• Ultrasound contrast media are generally safe Type and severity of • The majority of reactions are minor (e.g. headache, nausea, sensation of
reactions:
heat, altered taste) and self-resolving. • Allergy-like reactions occur rarely. To reduce the risk:
• Check for intolerance of any of the components of the contrast agent • Use the lowest level of acoustic output and shortest scanning time to Treatment:
● If a serious event occurs - refer to ESUR guidelines on management of 3.8. Safety of MR extra-cellular contrast media ESUR-guidelines 2005 Printed: 13-04-2006 Page: 12 of 15 Generally safe; low incidence of adverse event Similar type to those seen after iodinated contrast media If there has been a previous hypersensitivity-like reaction to gadolinium based compounds, consider an alternative modality or premedication (see ESUR guidelines on prophylaxis) Contrast medium induced May occur – see ESUR guidelines on nephrotoxicity nephropathy Dialysis See ESUR guidelines on pregnancy and lactation 3.9. Safety of liver specific MR contrast media Types of adverse
Similar to reactions observed with other types of contrast media such as reactions
nausea, vomiting, urticaria, rash, generalized anaphylactoid reactions. Back pain may also occur with superparamagnetic iron oxides Serious life threatening reactions are rare Patients < 18 years Safety has not yet been established
old
Contraindications
Known allergy or hypersensitivity to parenteral iron or dextran Known allergy to the preparation, Pregnancy, Lactation, Severe liver impairment, Cautions
In patients with hemosiderosis or hemochromatosis: iron-overload may be aggravated. • Agent with high hepatocyte uptake: Liver and renal failure • Agent with low hepatocyte uptake: Renal failure Recommended action

Contraindications
Use iodinated water-soluble contrast media In neonates and patients at risk of leakage into mediastinum and/or lungs use low- or isoosmolar contrast media ESUR-guidelines 2005 Printed: 13-04-2006 Page: 13 of 15 Use iodinated water-soluble contrast media and Cautions
Complications
ESUR Statement 3.11. Effects of iodinated contrast media on blood and endothelium The clinically important adverse effect of iodinated contrast media on blood and endothelium is thrombosis. It is recognized that: • All contrast media have anticoagulant properties, especially ionic agents. • High osmolar ionic contrast media may induce thrombosis due to endothelial damage, particularly in phlebographic procedures. • Drugs and interventional devices that decrease the risk of thromboembolic complications during interventional procedures minimize the importance of the effects of contrast media. • Meticulous angiographic technique is mandatory and is the most important factor in reducing • Low- or isoosmolar contrast media should be used for diagnostic and interventional angiographic procedures including phlebography. References 4. Publications from the Contrast Media Safety Committee of the European Society of Urogenital Radiology – numbered in chronological order. . 1. Thomsen HS, Morcos SK and members of contrast media safety committee of the European Society of Urogenital Radiology (ESUR). Contrast media and metformin. Guidelines to diminish the risk of lactic acidosis in non-insulin dependent diabetics after administration of contrast media. Eur Radiol 1999; 9: 738-740. 2. Morcos SK, Thomsen HS, Webb JAW and members of contrast media safety committee of the European Society of Urogenital Radiology (ESUR). Contrast Media Induced Nephrotoxicity: A consensus report. Eur Radiol 1999; 9: 1602-1613. ESUR-guidelines 2005 Printed: 13-04-2006 Page: 14 of 15 3. Morcos SK, Thomsen HS, Webb JAW and members of contrast media safety committee of the European Society of Urogenital Radiology (ESUR). Prevention of generalized reactions to contrast media: A consensus report and guidelines. Eur Radiol 2001; 11: 1720-1728. 4. Thomsen HS, Almén T, Morcos SK, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology. Gadolinium-containing contrast media for radiographic examinations: a position paper. Eur Radiol 2002; 12: 2600-2605 5. Bellin M-F, Jakobsen JÅ, Tomassin I, Thomsen HS, Morcos SK, Members of the Contrast Media Safety Committee of the European Society of Urogenital Radiology. Contrast medium extravasation injury: guidelines for prevention and management. Eur Radiol 2002; 12: 2807-2812. 6. Morcos SK, Thomsen HS, Webb JAW, Members of the Contrast Media Safety Committee of European Society of Urogenital Radiology. Dialysis and contrast media. Eur Radiol 2002; 12: 3026-1629. 7. Webb JAW, Stacul F, Thomsen HS, Morcos SK, Members of the Contrast Media Safety Committee of the European Society of Urogenital Radiology (ESUR). Late adverse reactions to intravascular iodinated contrast media. Eur Radiol 2003; 13: 181-184. 8. Thomsen HS, Morcos SK, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). Management of acute adverse reactions to contrast media. Eur Radiol 2004; 14: 476-481. 9. Molen Avd, Thomsen HS, Morcos SK, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). Effect of iodinated contrast media on thyroid function in adults. Eur Radiol 2004; 14: 902-906. 10. Thomsen HS, Morcos SK, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR) In which patients should serum-creatinine be measured before contrast medium administration? Eur Radiol 2005; 15; 749-754. 11. Jakobsen JA, Oyen R, Thomsen HS, Morcos SK, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). Safety of ultrasound contrast agents. Eur Radiol 2005; 15: 941-945 12. Webb JAW, Thomsen HS, Morcos SK, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). The use of iodinated and gadolinium contrast media during pregnancy and lactation. Eur Radiol 2005; 15: 1234-1240. 13. Morcos SK, Thomsen HS, Exley CM, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). Contrast Media: Interaction with other drugs and clinical tests. Eur Radiol 2005; 15: 1463-1468 14. Bellin M-F, Webb JAW, Molen AJvd, Thomsen HS, Morcos SK, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). Safety of MR liver specific contrast media. Eur Radiol 2005; 15: 1607-1614. ESUR-guidelines 2005 Printed: 13-04-2006 Page: 15 of 15 15. Aspelin P, Stacul F, Thomsen HS, Morcos SK, Molen AJvd, Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). Effects of iodinated contrast media on blood and endothelium. Eur Radiol 2006; 16: in press

Source: http://www.urologyuk.co.uk/Documents/New%20ESUR%20guidlines.pdf