CLINICAL GUIDELINES FOR THE ADMINISTRATION OF IODINATED IV CONTRAST

Prepared by: Saminah Yunis

Contributions by; Dr Kanwar Gill

Dr Raju Kalidindi

Date of first issue: July 2007

Date approved by CMC:

Review date: Oct 2012

Version: 4

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CONTENTS

1) INTRODUCTION

2) AIMS AND OBJECTIVES

3) ETHICAL AND LEGAL CONSIDERATIONS

4) INTER-RELATIONSHIP WITH OTHER GUIDELINES

5) KNOWLEDGE, SKILL AND COMPETENCE

6) BODY OF GUIDELINES

7) AUDIT PROCESS

8) ACCOUNTABILITY

9) REFERENCES

APPENDIX 1 - Anaphylaxis protocol summary sheet

APPENDIX 2 - Guidelines for Junior Doctors injecting contrast

APPENDIX 3 – Injecting check list

APPENDIX 4 - Pathway for Contrast Examinations

APPENDIX 5 - Pathway for Contrast use in patients on

Metformin

APPENDIX 6 - Patient information sheet for advice on the

extravasation of contrast

APPENDIX 7 - Competence certificate

10) EQI

11) DOCUMENT CONTROL

INTRODUCTION

1.1 Reactions

Adverse reactions associated with the administration of iodinated contrast agent are rare. Most reactions are minor. The incidence of severe and life threatening reactions with non-ionic agents is less than 0.04% but they require immediate medical intervention.

Please refer to the Trusts Corporate Policy ‘Protocol for the Management of Acute Anaphylaxis by first Responders’

(Appendix 1 Anaphylaxis summary sheet)

1.2 Contrast induced Nephrotoxicity

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 in the absence of an alternative etiology.

1)AIMS AND OBJECTIVES

2.1 Aims:

  1. These guidelines provide a clinical governance framework for Doctor’s and radiographers administering IV Contrast agents. They provide guidance on how contrast media may be used as safely as possible
  2. In order to minimise risk it is important to identify individuals for whom there is an increased risk of adverse event or contrast induced nephrotoxicity.
  3. Appropriate steps to reduce the risk of contrast reactions should always be taken

2.2 Objectives:

In relation to administering IV Contrast agents:

a. Detail the persons this policy applies to

  1. Outline the scope of practice for radiographers administering IV Contrast Agents

2)ETHICAL AND LEGAL CONSIDERATIONS

Only radiographers who hold a Certificate of Competence in Administrating

Intravenous Injections may administer contrast injections.

The Trust accepts vicarious liability for radiographers undertaking this role.

4) INTER-RELATIONSHIP WITH OTHER GUIDELINES

These guidelines have an inter-relationship with the following policies

  • Protocol for the Management of Acute Anaphylaxis by First Responders (2006)
  • Operational Policy for Radiographers undertaking Intravenous Contrast Injections (2005)

5) KNOWLEDGE, SKILL AND COMPETENCE

All medical staff administering iodinated contrast agent must have the appropriate knowledge, skill and competence required to perform this task.

All junior medical staff administering contrast in the acute setting in the absence of a Radiologist must read the laminated Guidelines for Junior Doctors injecting contrast agents before they administer iodinated contrast

(Appendix 2)

The training programme for Radiographers in the Mid Yorkshire NHS Trust involves written records of experience in phlebotomy, IV Cannulation and resuscitation. Supplementary to this they will have undertaken theoretical training covering the following topics;

  • Anatomy including route of injection
  • Contrast reactions
  • Medico-legal aspects
  • Infection control
  • Patient Group Directives

Continuous professional development is essential.

6) BODY OF GUIDELINES

  • Before administering iodinated contrast agents intravenously, the person injecting will be responsible for ascertaining from the patient whether there are any contra-indications (Appendix 3) or risk factors for contrast induced nephrotoxicity.
  • If the patient has any of the contra-indications or risk factors then the radiographer must liaise with the designated radiologist or on-call radiologist before the contrast injection is given.
  • The person who has ascertained that there are no contraindications or risk factors for the administration of contrast , should then record this information on the RIS System. This will then be a permanent record of the administration of contrast
  • Contrast agents may be administered to any patient (without contraindications in Appendix 3) who has a normal serum creatinine level of up to 120 µmol/l or an e GFR level which is above 60.

(This value is accepted as the upper limit of normal for the Mid Yorkshire Trust)

  • Facilities for treatment of acute adverse reactions should be readily available and regularly checked
  • A patient should not be left alone or unsupervised in the first 5 minutes after injection of the contrast agent
  • Out patient’s must remain in the department and be observed with the cannula in situ for 30mins post contrast injection
  • In patients may return back to the ward once the examination is completed with the cannula in situ. The ward must be informed that the cannula is still in place and that the patient is observed for any delayed allergic reaction to contrast. The cannula can be removed by the ward after 30mins.
  • 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 notes.

6.1Serum Creatinine Levels and e GFR levels

The level of creatinine in the blood is a useful guide to kidney function, but GFR (glomerular filtration rate)) is a more accurate measure. The serum creatinine level needs to be known before the GFR level can be calculated.

  • Risk factors include

Raised creatinine levels particularly secondary to diabetic nephropathy

Known renal impairment

Dehydration

Congestive heart failure

Age over 70years old

Concurrent administration of nephrotoxic drugs, e.g. non-steroid anti-inflammatory drugs

  • For an e GFR (estimated glomerular filtration rate) or GFR result to be deemed recent enough to provide adequate assurance of the patient’s renal function the results must have been obtained within the previous three months of the date of the examination.
  • All patients referred for a blood test from primary care along with their creatinine levels will already have had their e GFR level calculated and this information can be found on the Pathology results viewer
  • For patients where the serum creatinine level is available the e GFR level can be obtained as long as the patient’s age and sex are known. This information can be input into an instant e GFR calculator available at
  • For patients where the serum creatinine is not available, and to prevent delays in the patient’s investigation, the appointment centre will send an appointment to the patient along with a blood test request. The patient will be asked to attend for a blood test at least 3 days before the appointment time. On the request form we will be able to ask for the e GFR level to be calculated.
  • The calculated e GFR level will replace the original creatinine groups
  • e GFR > 60 – no significant renal impairment , can proceed with examination.
  • e GFR between 30 and 60 – mild to moderate renal impairment. Can be done if patient is hydrated before and after the examination.
  • e GFR < 30 – Severe renal impairment. Examination cannot be performed without full consultation with Radiologist

(See appendix 4 –Pathway)

N.B For scenarios b) and c)

  1. Always consider alternative imaging not requiring administration of iodinated contrast media.
  2. Use lowest volume of contrast possible
  3. Use low osmolar contrast media
  4. Stop administration of nephrotoxic drugs for at least 24hours.
  5. Avoid repeating iodinated contrast medium injection within the next 3 days.

6.2 Hydrating the patient

Give at least 100ml (oral (soft drinks) or intravenous (normal saline) depending on the clinical situation) per hour starting 4 hours before the injection and continue for 8hours post procedure

6.3 Contrast use in patients on Metformin

Metformin is not recommended for use in diabetics with renal impairment, because it is exclusively excreted via the kidneys. Accumulation of Metformin may result in the development of the serious complication lactic acidosis. Although the incidence of lactic acidosis following contrast administration in diabetic patients receiving Metformin appears to be extremely low, extra care should be exercised in these patients.

Advice

• If the serum creatinine is normal, there is no need to omit Metformin.

• If the serum creatinine is raised, the need for the contrast agent should be re-assessed. If contrast injection is deemed necessary, Metformin should be withheld for 48 hours post contrast injection and the decision to re-commence Metformin thereafter be left with the referring clinician. Metformin can be resumed providing a normal serum creatinine level is obtained 48hours post injection. The referring clinician should be reminded that Metformin use is not advised in patients with impaired renal function.

(It is the clinical team’s responsibility to change the medication in the light of the contraindication to administer Metformin in the presence of renal impairment. Patients whom this is relevant to, on leaving the department, will be provided with a reminder for the attention of the clinical team looking after)

(See Appendix 5 - Pathway)

6.4IV Contrast and lactation (breast feeding)

A very small percentage of the injected dose enters the breast milk and virtually none is absorbed across the normal gut. Guidelines issued by The Royal College of Radiologists indicate that no special precautions or cessation of breastfeeding is required in patients receiving iv contrast.

6.5Extravasation of contrast

Observation of the injection site should limit the amount of possible
extravasation. Should this occur the injection must be immediately stopped. Limited therapy such as compression over the puncture site or gentle manipulation of contrast back towards the needle may provide some patient comfort. Extravasation of a full bolus of contrast during a CT Procedure may require an urgent referral to Plastics.

In the event extravasation of contrast occurs, on leaving the department, the patient should be given a patient information sheet.

(Appendix 6 –Patient information sheet)

7) AUDIT PROCESS

The audit cycle is a risk management cycle aiming to eliminate, minimise or manage risk and evaluate the quality of service provided. Therefore all Doctors and Radiographers administering iodinated contrast agent should regularly audit their work to maintain and further their role development.

8) ACCOUNTABILITY

The person administering intravenous contrast agent is responsible for their actions or omissions.

The overall responsibility for the patients’ management remains with the referring clinician.

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9) REFERENCES

Board of the faculty of Clinical Radiology, The Royal College of Radiologist (2005) Standards for iodinated intravascular contrast agent administration to adult patients: Royal College of Radiologists: London.

College of Radiographers (2003) Scope of practice. College of Radiographers: London.

Department of Heath (2003) 10 Key role for AHPs. Department of Health: London

European Society of Urogenital Radiology (2004) Guidelines on Contrast Media, Version 4.0

RoyalCollege of Radiologists (1999) Skills mix in clinical radiology. RoyalCollege of Radiologists: London.

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Appendix 1 Anaphylaxis Policy Summary Sheet

Title Protocol for the management of Acute Anaphylaxis by First

Responders.

Summary This document is based on the Resuscitation Council (UK)

Guidelines for the Management of Acute Anaphylaxis. The

purpose of this protocol is to equip appropriately trained first

responders to recognise anaphylaxis and to initiate treatment,

prior to the arrival of Senior Medical help. First responders will

include junior doctors, registered nurses, midwives and

appropriate Allied Health Professionals. All non-medical staff

must have successfully completed the Trust’s Intravenous Drug

Administration Programme. Speed of treatment in anaphylaxis

affects the outcome. It is therefore essential that first responders

know the essentials of anaphylaxis treatment. The Resuscitation

Steering Committee has approved the Protocol

Authors; Steve Prescott, Lesley Whittaker and Kay Carter, Resuscitation

Officers.

Contributors Ann Fonseca, Pharmacist, PinderfieldsGeneralHospital;

Members of the Resuscitation Steering Committee.

Version Number 1

Date; May 2004

Date due for review May 2006

CNST standards None

Guidelines for Junior Doctors injecting contrast agent for acute examinations

Please read this information before injecting Iodinated Contrast Agent

Approved drug name / Iopamidol
Trade name(s) /

NIOPAM

Licensed status / Prescription only medicine
Preparation(s) / Non- ionic contrast agent
Available in ampoules of 10mls, vials of 20ml or 30ml, and bottles of 20ml, 50ml, 100ml and 150mls.
Criteria for use / Iodinated Contrast medium for intravenous injection.
Action for excluded patients / N/A
Seek medical advice

Contraindications

Relative

Absolute /
  • Patients who are sensitive to iodine preparations
  • Asthma
  • Diabetics on Metformin
  • Patients with clinical evidence of renal failure
  • History of anaphylactic reaction to iodinated contrast media

Dose / Dependant on examination;
  • 50 – 100 MLS for intravenous urography
  • 50 – 150 mls for CT procedures

  • Before administering iodinated contrast agents intravenously, the person injecting will be responsible for ascertaining from the patient whether there are any contra-indications or risk factors for contrast induced nephrotoxicity.
  • The patient must not be left alone or unsupervised in the first 5 minutes after injection of the contrast agent
  • The Doctor administering contrast agent must remain in the department for at least 10minutes post injection.
  • Please read the back of this laminated card for instructions on the Management of adverse reactions to intravenous contrast media

Guidelines cont…. (Original copy will be laminated on to 1 sheet of A4)

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APPENDIX 3 – Injecting check list

Mid Yorkshire NHS Trusts - Radiology Directorate

Checklist to be completed prior to IV administration of contrast media

Date Patient Name Cris No

Yes / No
1 / Are you allergic to iodine? IV injection or skin allergy
2 / Do you suffer from any of the following
  • Asthma
  • Eczema
  • Heart disease
  • Kidney problems

3 / Do you have any other allergies
4 / Do you suffer from diabetes? Are you treated with metformin (glucophage)?

Injection details

Type ………………………Volume………………… Expiry Date…………….. Lot………….

Number of attempts Radiologists assistance needed?

Injected by …………………………………. Checked by ………………………………….

……………………………………………………………………………………………………………

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Appendix 4

Pathway Examinations Requiring Iodinated Contrast Agent

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Appendix 5

Pathway for contrast use in patients on Metformin

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Appendix 6

PATIENT ADVICE SHEET

You have had an examination during which a cannula was inserted into a vein in your arm. An injection of contrast media (X -ray dye) was passed through the cannula.

During the examination some of the contrast leaked into the tissue surrounding the vein and may cause some pain and swelling. This should resolve itself within the next 1 – 3 days, without any further treatment. A member of staff will contact you the next day to enquire about your well being, so please provide staff with a suitable telephone number, which they may use, before leaving the department.

It is not unusual to develop a little bruising around your injection site. However you must contact the CT department or your doctor if you have any of the following,

  • Numbness or tingling of the lower arm or hand
  • Redness or streaks at the injection site
  • Blisters at the site
  • Increased pain that does not get better over time
  • Coolness of the lower arm or hand
  • Any increase in the size of your arm
  • Weakened pulse when compared to unaffected arm

During working hours, Tel no: 0844 8118110 and ask for

Ext 84222 for DewsburyHospital

Ext 51598 for PinderfieldsHospital

Ext 7027 for PontefractHospital

After 5pm on weekdays and at weekends please contact Tel no: 0844 8118110 and ask for the A&E department at either Pinderfields or Dewsbury hospital. Please bring this letter with you if you need to come to the A&E department.

To alleviate any discomfort, you may take some simple pain relief such as Paracetamol. You may be advised to apply an ice pack to the affected area as detailed below. When sat resting, elevate your arm on two pillows.

ICE PACK METHOD

-To prevent ice burn, first smear a thin layer of cooking oil over the affected area.

-Wrap the ice pack (packet of frozen vegetables) in a damp towel and place on the affected area.

-Leave in place for 10 minutes.

-Repeat 3 – 4 times a day until the swelling subsides.

The skin should look pink where the ice pack has been resting. If the skin looks white and lumpy, like a nettle rash, do not continue using ice packs, apply a cold compress instead.

The same packet of frozen vegetables may be refrozen after each session in order that it may be used again.

The contents of the pack must not be eaten if defrosting and refreezing has occurred.

Author Sarah Hanson CT Radiographer 03/11/2009

Contributor Ruth Clarke CT Clinical Lead

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APPENDIX 7 - Certificate of Competence

Radiographer’s Certification

.

CERTIFICATE OF COMPETENCE FOR THE ADMINISTRATION OF INTRAVENOUS CONTRAST AGENTS.