Guidelines regarding the use of Intravenous Contrast Media



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TRUST POLICY

IMAGING DEPARTMENT

INTRAVENOUS CANULATION AND ADMINISTRATION OF INTRAVENOUS CONTRAST MEDIUM

GUIDELINES FOR RADIOGRAPHERS & RADIOLOGISTS

Authors: Bradley Park, Deputy Imaging Services Manager, RBH

Trupti Patel, CT Superintendent Radiographer, HH

Dr. Tarun K. Mittal, Lead Clinician & Consultant Radiologist, HH

Approved by: …………………………………………………………………..

Drugs & Therapeutics Committee, RBHT,

Implemented by: …………………………………………………………………

Prof. D.M.Hansell, Director of Imaging, RBH

…………………………………………………gist……………….

Dr. Andrew Kelion, Director of Imaging, HH

Issue Date: Jan 2013

Review Interval: 2 years

SUMMARY OF THE DOCUMENT

This guideline deals with intravenous cannulation and administration of intravenous (IV) contrast medium by Radiographers for CT Scanning and Intravenous Urography in Imaging Departments throughout the Trust.

TIMETABLE

The authorised guidelines will be distributed to all relevant clinical areas in paper format and posted on the Trust Intranet – Policies and Guidelines/Policies and Procedures/Patient Related

Dissemination:

• Imaging Department, Royal Brompton Hospital

• Imaging Department, Harefield Hospital

Review: 2 years

ASSOICATED DOCUMENTS

Patient Group Directive for Intravenous or Intra-arterial Administration of Radiographic Contrast Media

CONTENTS

1. The Purpose of Guideline

2. The Imaging Process

3. Patient information and consent

4. Practical safety issues

5. Identifying patients at increased risk for contrast reaction

5.1 History of previous contrast reaction

5.2 Asthma

5.3 Multiple allergies or a documented severe allergy requiring therapy

5.4 Renal disease, diabetes mellitus and conditions associated with renal impairment

5.5 Metformin

6. Other special cases

7. Eligibility of radiographers for intravenous cannulation, administration of iodinated contrast media and general procedural guidelines

8. Procedure for intravenous cannulation and administration of intravenous contrast media by radiographers

9. Management of adverse reactions to contrast medium (for all radiographers)

10. Guidelines following extravasation of contrast medium

11. References

Appendix 1 - Estimated GFR

Appendix 2 - Metformin patient information letter

Appendix 3 - Extravasation patient information letter

Appendix 4 - Management of adverse reactions

Appendix 5 - Cannulation Equipment Guidelines

Appendix 6 - Check-list prior to adminstration of intravenous contrast medium

1. THE PURPOSE OF GUIDELINE

The use of iodinated intravascular contrast agents (hereby referred to as ICM) has increased dramatically in recent years in all aspects of imaging as they provide valuable diagnostic information. However they are not without side effects and thus the potential risks of intravascular administration of contrast media must be weighed against the potential benefits. At the same time, withholding agents may deprive patients of the benefits of valuable diagnostic information or necessary therapy.

This guideline aims to ensure that :

1. Overall safety of the patient is maintained in the process of intravenous administration of ICM.

2. Patients who are at increased risk of contrast reactions are identified as early as possible, so that adequate measures can be taken prior to the examination.

3. Radiographers undertaking Intravenous cannulation and administration of ICM are adequately trained and familiar with the procedures required to perform the ICM administration safely.

4. All radiographers are familiar with management of reactions to ICM.

The ultimate responsibility for the administration of contrast medium rests with the supervising radiologist, although the delivery of the injection is frequently delegated to radiographers.

The introduction of low osmolar non-ionic contrast has reduced the frequency of reactions to contrast medium, but there are higher than average risk groups that radiographers must be aware of.

This guideline deals with administration of contrast medium to adult patients. For children and neonates, the supervising radiologist should be consulted.

2. THE IMAGING PROCESS

1. The CT scan process

1. All CT scan requests must be protocoled by the supervising radiologist with a written instruction (on the request form) if contrast media is required for the CT scan.

2. The contrast media should be injected following a written protocol, unless otherwise directed by supervising radiologist.

3. All radiographers in CT scanning must check with each patient for known allergies or risks.

4. All cannulating radiographers must adhere to cannulating procedure.

5. All radiographers in CT scanning should be aware of risks entailed in the injection of contrast medium and know how to manage them appropriately.

2.2 Intravenous Urography (IVU)

2.2.1 This procedure is much less commonly performed in the Trust and always involves the use of ICM.

2.2.2 The same process, as for CT scanning should be followed.

3. PATIENT INFORMATION AND CONSENT

Patients should always be fully informed about the CT scanning procedure and understand what it will involve. For out-patients this has to be done by enclosing the appropriate patient information leaflet with the appointment letter. Besides, the leaflets are to be made available to the patients in the CT waiting area. In all cases (both in and out-patients), the radiographer who administers the contrast medium and/ or performs the procedure must explain the procedure to the patient and go through the questions to identify risks that patient may have pertaining to contrast administration if it is to be administered. Ideally the risks should have been identified earlier by procedures outlined in section 5, and appropriate action taken before the patient comes for the scan.

The radiographer must still ensure that the patient understands the procedure, risks have been identified and appropriate action taken and agrees verbally to proceed. This is documented on the reverse side of the Trust’s Imaging request form.

4. PRACTICAL SAFETY ISSUES

▪ Two members of staff should be present in the scanning suite, if possible, when a radiographer is cannulating and injecting contrast.

▪ In the event of a severe contrast reaction, staff on duty should have should have the knowledge to seek urgent medical help by contacting the Cardiac Arrest Team.

▪ In presence of risk factors, the decision about contrast agent administration should be taken only by the radiologist supervising the procedure.

▪ In view of the risk of contrast nephrotoxicity, dehydration of patients prior to contrast agent administration is undesirable and should be avoided.

▪ Facilities for treatment of acute adverse reactions should be readily available and regularly checked.

▪ A patient should not be left alone or unsupervised for the first 5 minutes after injection of the contrast agent.

▪ It is advisable that the patient remains within the Imaging (or CT) Department for, at least, 15 minutes after the injection. Most severe reactions occur during this time. In patients at increased risk of a reaction, this should be increased to 30 minutes.

▪ All contrast reactions, with details of their nature, severity, and the agent used, should be included in the radiological report and updated in the patient’s record.

5. IDENTIFYING PATIENTS AT INCREASED RISK FOR CONTRAST REACTION

The following essential information should be sought from the referring clinician / patient before the contrast injection includes:

• Previous contrast reaction

• Asthma

• Renal problems

• Diabetics on Metformin therapy

• Patients who are dehydrated or in congestive heart failure are at higher risk of contrast induced renal failure.

However, the Imaging departments must make all possible efforts to ensure that this information is available when the examination is requested in the following manner:

A: For elective out-patient procedures:

▪ By ensuring that the necessary fields relating to above risk factors are adequately filled by the referring clinician for examinations where contrast may be required.

▪ Through patient information leaflets and appointment letter in which they are informed of the possibility of injection of an intravenous contrast (dye) and asked to ring up the Imaging department in advance if they are aware of having any of the above risk factors.

▪ Recent eGFR (performed within last 2 months) must be available as per 5.4.3

B. For non-emergency in-patient procedures:

▪ By making sure that the necessary parts relating to above risk factors are adequately filled by the referring clinician for examinations where contrast may be required.

▪ Recent eGFR (performed most recent during the current admission) or Serum Creatinine (if eGFR not available) must be available as per 5.4.3

C. For emergency in-patient procedures:

▪ In these cases the potential benefits of using contrast agents must be weighed against the potential risks. In these cases the ICM injection should be followed by a generous saline flush (40-50mls) and post-procedural hydration as in 5.4.6, if patient has no contra-indication.

If any risk factor is identified by the above process, appropriate measures should be taken as per the local procedures described below and if necessary the supervising radiologist should be consulted.

The level of information provided on the request forms will be monitored and regularly audited.

5.1 History of previous contrast reaction

5.1.1 Caution should be exercised when there is a previously reported moderately severe (e.g. bronchospasm or uticaria requiring treatment) or a severe reaction (e.g. laryngeal or angioneurotic oedema, severe bronchospasm or collapse).

2. Determine the exact nature of the previous reaction and what agent used on that occasion.

3. The supervising radiologist must assess the risk/benefit of the procedure.

4. If administration of contrast is deemed necessary:

• use a different (non-ionic low or iso-osmolar) agent to that previously used

• maintain close medical supervision

• leave the cannula in place and keep the patient under observation for 30 minutes

• and be ready to treat promptly any adverse reaction and ensure that emergency drugs and equipment are available

5.1.5 Pre-treatment with steroids should be considered only after consultation with the supervising radiologist and the referring clinician.

5.2 Asthma

5.2.1 Asthmatics are at an increased risk of severe contrast reactions by a factor of 6 with low osmolar non-ionic contrast media and by a factor of 10 with high osmolar agents.

2. Determine whether the patient has true asthma or COPD, and whether the asthma is currently well controlled.

3. If the patient is wheezy or reports that their asthma is currently not well controlled and the CT scan is not urgent, it should be deferred and the patient referred back for appropriate medical therapy.

4. The supervising radiologist must reassess to decide whether to undertake the CT scan with contrast medium.

5. If administration of contrast is deemed necessary:

• use a non-ionic low or iso-osmolar agent

• maintain close medical supervision

• leave the cannula in place and keep the patient under observation for 30 minutes

• and be ready to treat promptly any adverse reaction and ensure that emergency drugs and equipment are available

2. Multiple allergies or a documented severe allergy requiring therapy

1. Individuals with multiple, well documented allergies or a single very severe allergy are at increased risk.

5.3.2 There is no conclusive evidence of benefit for the prophylactic use of steroids in the prevention of severe reactions to contrast medium.

3. Determine the nature of the allergies and their sensitivity (N.B. there is no specific cross reactivity with shellfish or topical iodine in acute reactions).

4. In patients with multiple or severe allergy, the supervising radiologist must reassess the need for contrast administration.

5. If administration of contrast is deemed necessary:

• use a non-ionic low or iso-osmolar agent

• maintain close medical supervision

• leave the cannula in place and keep the patient under observation for 30 minutes

• and be ready to treat promptly any adverse reaction and ensure that emergency drugs and equipment are available

3. Renal disease, diabetes mellitus and conditions associated with renal

impairment

1. In patients with renal impairment, all contrast agents, including non-ionic low osmolar and iso-osmolar agents are nephrotoxic.

2. The risk of contrast nephrotoxicity is related to the extent of pre-existing renal impairment, the dose of contrast agent administered and the state of hydration of the patient. Congestive heart failure, over the age of 70 years old and concurrent administration of nephrotoxic drugs are also risk factors for contrast nephrotoxicity.

3. A recent eGFR (performed within last 2 months for out-patients and most recent during the current admission for in-patients) should be available for all patients with a history of renal disease or diabetes. A level of 120 micromoles per litre for serum creatinine has been used in the literature to indicate renal impairment. Patients with an eGFR level of 70 |Diuretic use, especially furosemide |

|Diabetes mellitus |Hypertension |

|Contrast load in last 72hrs |Hyperuricaemia or hypercholesterolaemia |

|Congestive Cardiac Failure |Multiple myeloma |

4. Metformin

5.5.1 Metformin is not recommended for use in diabetics with renal impairment because it is exclusively excreted via the kidneys, if excretion is prevented this can result in lactic acidosis.

5.5.2 The use of Metformin should not be considered an issue when the decision is made to administer IV contrast to a patient. As with all patients the renal function should be examined and used as an indication of whether the patient is suitable for IV contrast.

5.5.3 The discontinuing of Metformin should only be considered in patients with renal impairment, as defined in section 5.4.3, and only after Consultation with the referring clinic.

6. Other special cases

6.1 Pregnancy: In exceptional circumstances, iodinated contrast may be administered during pregnancy. Because of the small theoretical risk of thyroid suppression in the foetus, thyroid function should be measured in the first week after birth.

6.2 Lactation: A very small percentage of the injected dose enters the breast milk and virtually none is absorbed across the normal gut and no special precaution or cessation of breastfeeding is required.

3. Thyroid: Intravascular contrast should not be administered if the patient is

hyperthyroid. In patients with thyroid cancer, the use of iodinated contrast

agents will preclude therapeutic radio-iodine treatment for 2 months. MRI is

the preferred staging method in these patients.

6.4 Interleukin-2 treatment: A specific risk of delayed skin rash is associated with Interleukin-2 therapy. Oncologists should be informed that they should always indicate if the patient is on this drug when referring them for a contrast injection.

7. Eligibility of Radiographers for Intravenous Cannulation, iodinated

contrast administration and general procedural guidelines

7.1 The cannulating radiographer will have been formally approved and certified by Departmental Clinical Director / Lead Clinician for IV cannulation. He or she should have completed an intravenous cannulation certificate course and should be able to demonstrate and maintain regular competency.

7.2 All eligible radiographers should be familiar with procedures and guidelines regarding management of reactions to intravenous contrast media as in sections 9, 10 and Appendix 4.

7.3 The cannulating radiographer must follow the Procedure for Injecting of Intravenous Contrast Medium as outlined in section 8.

7.4 Radiographers must inject only non-ionic contrast (they are not certified to inject other materials).

7.5 The radiographer should not cannulate in the following circumstances:

• Paediatric patients (aged 15 years and below).

• Patients with a previous allergic reaction

• Out of hours

7.6 The radiographers will regularly audit their work, assessing first time accuracy for injections, number of extravasations and number of contrast medium reactions.

7.7 The cannulating radiographer should complete Intermediate Life Support

Course, as well as the Basic Life Support Course, annually.

8. Procedure for Intravenous Cannulation and Administration of Intravenous Contrast Media by radiographer

8.1 Patient ID and clinical details must be carefully checked by the radiographer as per hospital identification policy.

8.2 The radiographer should introduce themselves by name and professional title.

8.3 An explanation of the CT scan should be given to patient, including the reason for the intravenous injection.

8.4 Two members of staff should be present in the scanning suite, if possible,

when a radiographer is cannulating and injecting contrast.

8.5 The patient must be questioned for known allergies. The checklist prior to administration of Intravenous Contrast flow diagram (see Appendix 6) should be used and documented on the reverse of the Imaging request form.

8.6 The Infection Control – Hand Hygiene Policy must be adhered to throughout the procedure.

8.7 The radiographer should select an appropriate vein in the ante-cubital fossa or dorsum of the hand and introduce a cannula into the vein and secure it. The cannula should be flushed with saline (5-10 mls) to check for proper positioning and any extravasation. Cannulation Equipment Guidelines (Appendix 5) should be followed.

8.8 If the radiographer is unable to cannulate after the second attempt, medical

assistance must be sought.

8.9 Before injecting, the type and amount of contrast medium to be used must be checked by another radiographer.

8.10 The local written filling procedure for automatic injectors, displayed near each

injector, must be followed.

8.11 The contrast media should be injected as per examination protocol. If extravasation occurs, stop injecting immediately and the CT scan procedure. Follow guidelines following extravasation (Section 10).

8.12 If any adverse reaction occurs, summon assistance immediately – DO NOT REMOVE NEEDLE OR CANNULA. Follow management of adverse reactions to contrast media (Appendix 4).

8.13 Complete the examination and remove needle or cannula ensuring the needle is disposed of safely. The Health and Safety – Waste Disposal Policy must be adhered to at all times. Check bleeding has stopped before covering injection site.

8.14 The cannulating radiographer will record their name and number of

cannulation attempts manually or electronically in the CT Scanning daily register.

8.15 The type and amount of contrast medium must be recorded in Radiology Information Support System for each patient.

9. Management of Reactions to Intravenous Contrast Medium

(For all Radiographers)

9.1 All radiographers in CT scanning should be aware of risks entailed in the injection of contrast medium. They should also be aware of the pharmacology and adverse reactions of other pharmaceutical agents used in the Radiology Departments. Although the risks associated with contrast medium have been reduced significantly with the advent of non-ionic agents, nonetheless allergic reactions still occur.

9.2 All radiographers must be aware of the location of resuscitation equipment

and contrast reaction box. These should be immediately available.

9.3 The checking and maintenance of resuscitation equipment is the responsibility

of the Superintendent Radiographer.

9.4 A patient should not be left alone or unsupervised in the first 5 minutes after injection of the contrast agent. The cannula should be left in place for at least 10 minutes. And it is advisable that the patient remains in CT scanning department for at least 15 minutes after the injection. In patients at increased risk of a reaction, this should be increased to 30 minutes.

9.5 Radiological assistance must be summoned if there is concern or doubt as to whether a patient is experiencing a contrast reaction. If

9.6 The treatment of reactions should be followed by using The Royal College of Radiologists guidelines (Standards for iodinated intravascular contrast agent administration to adult patients, 2005), Appendix 4.

9.7 Records must be kept of all monitoring and treatment given to patients immediately after they have experienced an adverse reaction to IV contrast. These records should be kept using the CT General Observation sheet, Appendix 7.

9.8 All adverse reactions must be recorded in the Hospital Information Support System, daily register file and a Trust Incident form should be filled in. Medicines Information (Pharmacy Department – Royal Brompton Hospital ext 8901) must be informed and the batch number of the contrast media must be noted.

10. Guidelines following Extravasation of Contrast Medium

10.1 Action:

10.1.1 Attempt to aspirate the fluid using the needle through which the extravasation has occurred.

10.1.2 The affected extremity should be elevated above the level of the heart.

10.1.3 Apply a cold compress to affected area (use chilled water from water cooler).

10.1.4 An incident form should be filled in.

10.1.4 Extravasation incident should be noted in patient notes.

10.1.5 Verbal notification should be given to the medical staff looking after the patient with the request for close follow-up by team.

10.1.6 A letter should be given to the patient informing them of recommendations of treatment following an extravasation incident (see Appendix 3).

10.2 Recommendations:

10.2.1 Contact Medicines Information (Pharmacy Department – Royal Brompton Hospital) on ext 8901 for treatment advice immediately.

2. For extravasation of over 100ml of contrast medium, a consultation with a plastic surgeon should be considered urgently.

3. Application of a cold compress is associated with significant decrease in the size of subsequent ulcers.

4. Follow-up contact should be made within 24 hours of the extravasation event. This is used to confirm that there are no ongoing complications relating to the extravisation of contrast material.

REFERENCE DOCUMENTS

Aspelin P, Aubry P, Fransson S-G, Strasser R et al, for the NEPHRIC Study Investigators. Nephrotoxic Effects in High Risk Patients Undergoing Angiography. New England Journal of Medicine 2003 348:491-499

Bellin MF, Jakosen JA, Tomassin HS, Morscos SK, Contrast Media Safety Committee of the European Society of Urogenital Radiology. Contrast media extravasation injury: guidelines for prevention and management. European Radiology 2002. 12:2807-2812

Cohan RH, Ellis Jh, Garner WL. Extravasation of radiographic contrast material: recognition, prevent and treatment. Radiology 1996. 200:593-604

Cohan RH et al. Extravasation of non-ionic radiologic contrast media: efficacy of conservative treatment. Radiology 1990 176:65-67

European Society of Uroradiology Guidelines on Contrast Media Media version 4.0, 2000.

Health & Safety – Waste Disposal Policy – Royal Brompton Hospital, March 2003

Infection Control – Hand Hygiene Policy – Royal Brompton Hospital, Aug 2002

Katayama H, Yamaguchi K, Kozuka T, et al. Adverse reactions to ionic and non-ionic contrast media: a report form the Japanese Committee on the Safety of Contrast Media. Radiology 1990. 175:621-628

Lasser EC. Pretreatment with corticosteroids to prevent reactions to i.v. contrast material: overview and implications. AJR 1988. 150:257-259

Molen AVD, Thomsen HS, Morcos SK and members of the Contrast Media Safety Committee of European Society of Urogenital Radiology. Effects of contrast media on thyroid function in adult. Euorpean Radiology 2004 14:902-907

Morcos SK. Contrast media-induced nephrotoxicity – question and answers. The British Journal of Radiology 1998. 71:357-365

Morcos SK, Thomsen HS, Webb JAW, et al. Contrast-media-induced nephrotoxicity: a consensus report. European Radiology 1999. 9:1602-1613

Morcos SK, Thomsen HS, Webb JAW, et al. Prevention of generalized reactions to contrast media: a consensus report and guidelines. Eur. Radiology 2001. 11:1720-1728

Morcos SK, Thomsen HS. Adverse reactions to iodinated contrast media. European Radiology 2001. 11:1267-1275

Morcos SK. Prevention of contrast media nephrotoxicity: the story so far. Clinical Radiology 2004. 59:381-389

Morcos SK. Prevention of contrast media nephrotoxicity following angiographic procedures. Journal of Vascular and Interventional Radiology 2005. 16:13-33

Morcos SK, Thomsen HS and members of the Contrast Media Safety Committee of European Society of Urogenital Radiology. Interaction between contrast media and other drugs. European Radiology 2005

Seymour R, Halpin SF, Hardman JA, et al. Corticosteroid prophylaxis in patients at increased risk of adverse reactions to intravascular contrast agents. Clinical Radiology 1994. 49:791-795

Standards for iodinated intravascular contrast agent administration to adult patients, Royal College of Radiologists, London, Octorber 2010

Thomsen HS, Morcos SK and members of the Contrast Media Safety Committee of the European Society of Urogenital Radiology. Contrast media and Metformin. Guidelines to distinguish the risk of lactic acidosis in non-insulin dependent diabetics after administration of contrast media. European Radiology 1999 9:738-740

Thomsen HS, Morcos SK and members of the Contrast Meida Safety Committee of the European Society of Urogenital Radiology. Management of acute adverse reactions to contrast media. European Radiology 2004 476-481

Thomsen HS, Morcos SK, and members of the Contrast Media Safety Committee of the European Society of Urogenital Radilogy. When serum creatinine should be measured before contrast medium injection. Euoropean Radiology 2005

Webb JAW, Stachul F, Thomsen HS, Morcos SK et al. Late adverse reactions to iodinated contrast media. European Journal 2003 13:181-184

Webb JAW, Thomsen HS, Morcos SK and members of the Contrast Media Safety Committee of European Society of Urogenital Radiology. Effects of contrast media in pregnancy and lactation. European Radiology 2005

APPENDIX 1 Document from Clinical Biochemistry, RBHT

Estimated GFR

The National Service Framework for Renal Services recommends that the most sensitive way to detect chronic kidney disease (CKD) is by the use of a formula-based estimation of glomerular filtration rate (eGFR), using the 4-variable (serum creatinine, age, gender, ethnic origin) Modification of Diet in Renal Disease (MDRD) equation. Although aimed at the primary care sector, the DoH information states that “eGFR should be reported on all adult samples carrying a request received by laboratories for serum creatinine measurement”.

Estimated GFR using the MDRD equation is not universally applicable; it has not been validated for use in patients younger than 18 years old, in patients with acute renal failure, pregnancy, oedematous states, muscle wasting disorders, amputees, and malnourished people. It has only been validated for use in the Caucasian, and African-Caribbean racial groups.

We propose to make eGFR available automatically on all requests for serum creatinine received from out-patients and GP patients, from August 1st 2006. We will also offer the investigation on adult in-patients, but only by specifically requesting “GFR” on the request form.

The following comment will be attached to each eGFR report:

“If the patient is of African-Caribbean origin, then the eGFR result must be multiplied by 1.212”.

For eGFR values >60 mL/min/1.73m2 the following comment will be added:

“GFR estimates >60 mL/min/1.73m2 do not indicate CKD unless there is other existing laboratory / clinical evidence of disease”.

For eGFR values in the range 30-59 mL/min/1.73m2:

“Moderately decreased GFR (CKD stage 3)”.

For eGFR values in the range 15-29 mL/min/1.73m2:

“Severely reduced GFR (CKD stage 4)”.

For eGFR values 100mls: stop Metformin for 48hrs after injection

Give contrast

with careful observation

No ALLERGY but vomiting/flushing

If contrast is necessary

• Hydrate patient

• Use Visipaque

Referring clinician should be notified of contrast nephrotoxicity risk before exam

• Check contrast necessary

If deemed necessary;

• withhold metformin for 48 hrs before scan & 48 hrs after contrast

• restart metformin following re-evaluation of renal function

• give pt. / ward advice letter

Supervising radiologist to reassess the need for contrast

Creatinine >130

Or EGFR ................
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