INTRAVENOUS CONTRAST USE IN DIALYSIS PATIENTS WITH
ESTABLISHED RENAL FAILURE
GUIDELINE
Version / 1Name of responsible (ratifying) committee / Wessex Kidney Centre Governance MDT
Date ratified / 20 January 2017
Document Manager (job title) / Dr Amir Bhanji (Consultant Nephrologist)
Dr Katey Atkins (Registrar – Nephrology)
Dr David Flowers (Consultant Interventional Radiologist)
Date issued / 07 February 2017
Review date / 07 February 2019
Electronic location / Clinical Guidelines
Related Procedural Documents / N/A
Key Words (to aid with searching) / Haemodialysis, Peritoneal dialysis, Contrast
Version Tracking
Version / Date Ratified / Brief Summary of Changes / Author1 / 20/1/2017 / New Guideline / N/A
CONTENTS
Quick Reference Guide 3
1) Introduction 4
2) Purpose 4
3) Scope 4
4) Definitions 5
5) Duties and Responsibilities 5
6) Process 6
7) Training Requirements 6
8) References and Associated Documents 6
9) Equality Impact statement 7
10) Monitoring Compliance with Procedural Documents 8
11) Appendix – Further Information 9
QUICK REFERENCE GUIDE
1. INTRODUCTION
This policy is to clarify the timing of dialysis in relation to the administration of intravenous (IV) contrast for radiological investigations, in those with Established Renal Failure (ERF).
2. PURPOSE
The nature of renal failure and its co-morbidities expose renal patients to a large number of radiological investigations. These investigations often require the use of intravenous contrast in order to obtain suitable images.
A culture of delaying investigation, manipulating dialysis times or patients undergoing additional dialysis sessions has evolved due to perceived potential detriment of using intravenous (IV) contrast in patients with ERF.
In the majority of cases the delay or alteration to prescribed dialysis therapy is unnecessary.
Iodinated Contrast
Studies have shown there is no protective benefit in performing additional dialysis post iodinated contrast administration in patients with established renal failure. In addition there is a significant cost associated with delayed and additional dialysis session which may not be necessary.
Iodinated radiocontrast agents can cause acute tubular necrosis (ATN) and can theoretically lead to the loss of residual renal function (RRF). However several prospective studies have shown this not to be the case.
Gadolinium Contrast
Gadolinium has been associated with nephrogenic systemic fibrosis (NSF) in those with an eGFR (estimated glomerular filtration rate) <30ml/min. The highest association is with those whose eGFR is <15ml/min or requiring dialysis.
All those with ERF should be considered to be at risk of NSF when receiving gadolinium. However, if imaging is clinically indicated and careful consideration has been given to the risks and benefits, with no alternative imaging modality available, then the use if gadolinium should not be withheld.
3. SCOPE
This document applies to all patients receiving maintenance dialysis – either haemodialysis or peritoneal dialysis due to receive IV contrast.
Patients with an acute kidney injury (AKI) are excluded from this guideline. The responsibility lies with the referring team to distinguish between ERF and AKI.
With particular reference to the use of gadolinium in patients under the care of WKC – it is the responsibility of the named nephrologist (and their respective team) to ascertain the risk / benefit ratio, discuss with the patient and document appropriately (notes / renal electronic records (PROTON))
‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’
4. DEFINITIONS
Dialysis: The separation of particles in a liquid on the basis of differences in their ability to pass through a membrane
Maintenance dialysis: Long term dialysis treatment for those with irreversible (end-stage) renal failure (ERF)
Haemodialysis (HD): Treatment for end-stage renal failure. Removal of toxins and water from the
blood during the passage through an artificial semi-permeable membrane
Peritoneal dialysis (PD:)Treatment for end-stage renal failure. Peritoneal lining used as membrane to
facilitate removal of toxins and water
IV contrast: Radiopaque dye injected into a vein to enhance the visibility of vascular structures and
organs during radiographic investigations / procedures
eGFR: Estimation of the glomerular filtration rate (kidney function) using a formula and blood test
Nephrogenic systemic fibrosis (NSF): Condition involving fibrosis of skin, joints, eyes, and internal organs. Development associated with exposure to gadolinium in patients with renal impairment.
5. DUTIES AND RESPONSIBILITIES
It is the responsibility of the requesting physician to document clearly on the imaging request form that the patient receives dialysis for ERF.
It is the responsibility of the requesting physician to ascertain the risk / benefit ratio of administering IV contrast (iodinated and gadolinium based) and discuss this with the patient.
Iodinated Contrast
Radiological investigation requiring IV contrast requested by Wessex Kidney Centre – these can be preformed as requested.
Should there be a clinical change requiring additional dialysis the nephrology team will assess and arrange as needed
Radiological investigation requiring IV contrast requested by another QAH ward / inpatient team - these can be preformed as requested.
It will be the responsibility of the team responsible for care to liaise with the individuals’ nephrology consultant, registrar or on-call renal registrar as needed for advice.
Gadolinium Contrast
It will be the responsibility of the named nephrologist to decide if gadolinium removal via dialysis is appropriate – and document this on the referral. Details of removal efficacy are in the appendix.
Discussions with patients regarding receiving gadolinium should be documented in the patients’ notes and / or on the renal electronic system (PROTON) by the nephrologist / renal team in charge of care.
If removal of gadolinium with haemodialysis or rapid PD exchanges is deemed appropriate the investigation should be scheduled so that dialysis can occur as soon as possible after the scan. To achieve this the radiology department will need to liaise with the renal bed manager (on bleep 1572). It is the responsibility of the referring clinician to state the individuals dialysis days / time on the referral.
6. PROCESS
IN HAEMODIALYSIS PATIENTS WITH ERF
v Iodine-based contrast medium
· Correlating administering contrast medium with the haemodialysis session is NOT required.
· Extra hemodialysis session to remove contrast medium is NOT required.
v Gadolinium-based contrast medium
· If nephrology consultant recommends removal of gadolinium then:
▫ Correlation of the contrast medium injection with the haemodialysis session is recommended.
▫ Extra haemodialysis session may be needed
IN PERITONEAL DIALYSIS PATIENTS WITH ERF
v Iodine-based contrast medium
· Haemodialysis to remove the contrast medium is NOT required for iodine-based contrast medium
v Gadolinium-based contrast medium
· If nephrology consultant recommends removal of gadolinium then:
▫ It will be the responsibility of the named renal physician to decide which method of gadolinium removal is most suitable for the individual patient.
▫ If referral from non-renal team it must be discussed with named renal physician prior to the planned investigation.
For ALL IN-PATIENTS receiving IV iodinated contrast please document the volume in milliliters (mls) of IV contrast received in the patient notes.
(This is not required for those being scanned as an outpatient).
For ALL PATIENTS receiving IV gadolinium please document the preparation of gadolinium used and the volume in milliliters (mls) in the patient notes if available and on radiology computer system.
7. TRAINING REQUIREMENTS
Guideline will be available to all on the intranet – located in the Renal & Transplantation Speciality Guidelines and Policies page and in the Radiology Speciality Guidelines and Policies page.
Verbal dissemination of the guidelines will be carried out in the WKC and the radiology departments.
The quick reference flow chart will be disseminated to all radiographers via the hospital e-mail system with details of the location of the full guideline.
8. REFERENCES AND ASSOCIATED DOCUMENTATION
Contrast Media Safety Committee – European Society of Urogenital Radiology. ESUR.org
Morcos SK, Thomsen HS, Webb JAW, and members of the Contrast Media Safety Committee of the European Society of Urogenital Radiology (ESUR). Dialysis and Contrast Media. Eur Radiol 2002; 12: 3026-3030.
European Medicines Agency. July 2010 Doc. Ref. EMEA/727399/2009 rev. EMEA/H/A-31/1097. Questions and answers on the review of gadolinium-containing contrast agents
The Royal Australian and New Zealand College of Radiologists. Faculty of clinical radiology. Guideline on the use of Gadolinium containing MRI Contrast Agents in Patients with Renal Impairment
British Journal of Renal Medicine.2009. Vol 14, No 3. What I tell my patients about contrast medium toxicity. Ahmed, Williams and Scott.
Kidney International. 2006. 69 – S25. Dialysis and iodinated contrast media. Deray.
Nephrol. Dial. Transplant. 1999 14 (10): 2407-2412 Improved clearance of iohexol with longer haemodialysis despite similar Kt/V for urea. Malberti, Farina and Imbasciati
Radiology. 2007. Vol 245 (1) 168-175. Gadolinium-enhanced MR imaging and Nephrogenic Systemic Fibrosis: Retrospective Study of a Renal Replacement Therapy Cohort.
http://www.uptodate.com
https://www.rcr.ac.uk - Royal College of Radiology
http://www.ema.europa.eu. European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents
https://www.gov.uk/drug-safety-update
Drug Safety Update: Medicines and Healthcare products Regulatory Agency 2010. Therapeutic area: Radiology and imaging. Gadolinium-containing contrast agents: new advice to minimise the risk of nephrogenic systemic fibrosis
Safety data discussion with regional representative from Bayer – producer of Gadovist®.
9. EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds.
This policy has been assessed accordingly
Our valuesare the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They are beliefs that manifest in the behaviours our employees display in the workplace.
Our Values were developed after listening to our staff. They bring the Trust closer to its vision to be the best hospital, providing the best care by the best people and ensure that our patients are at the centre of all we do.
We are committed to promoting a culture founded on these values which form the ‘heart’ of our Trust:
Respect and dignity
Quality of care
Working together
Efficiency
This policy should be read and implemented with the Trust Values in mind at all times
Intravenous Contrast use in Dialysis Patients with Established Renal Failure Guidelines
Version: 1
Issue Date: 07 February 2017
Review Date: 07 February 2019 (unless requirements change) Page 2 of 11
10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS
Minimum requirement to be monitored / Lead / Tool / Frequency of Report of Compliance / Reporting arrangements / Lead(s) for acting on RecommendationsDocumentation in notes of volume of contrast used for inpatient scans – as a reflection of guideline implementation / Dr A Bhanji
Dr D Flowers / Audit / Initially 6 months after implementations
2 yearly there after – more frequently if felt necessary / Policy audit report to:
· Dr A Bhanji
· Dr D Flowers / Dr D Flowers
This document will be monitored to ensure it is effective and to assurance compliance.
11. APPENDIX – FURTHER INFORMATION
Iodinated Contrast
Iodinated intravenous (IV) contrast has historically been associated with nephrotoxicity, fluid overload, depression of myocardial contractility and arrhythmias when used in patients with renal impairment. There is therefore a reluctance to use these agents in patients with known renal failure on renal replacement therapy.
In theory the physical properties of contrast make them easy to remove with the use of haemodialysis - water soluble, low protein binding and low intracellular penetration. Peritoneal dialysis is also effective at removing contrast agents but takes longer to do so.
There is no evidence showing protective benefit of removing iodinated contrast in ESF patients, and if clinically indicated (no alternative imaging) should not be withheld.
Gadolinium Contrast
o Nephrogenic systemic fibrosis (NSF) is a rare complication with a range of clinical features from a solitary skin plaque to a rapidly progressive fatal condition. The pathogenicity of NSF is not fully understood; development following exposure has been reported to occur most commonly within days to months however case repots have documented its development 10 years later.
o There are several case reports of NSF occurring in gadolinium naive individuals.
o Some analysis of those with NSF (specifically a RRT cohort) found no difference in the overall mortality of those who developed NSF in comparison to those who did not.
All those with ERF should be considered to be at risk of NSF when receiving gadolinium. There is some evidence that patients on PD are at a higher risk than those on HD. However, if imaging is clinically indicated and careful consideration has been given to the risks and benefits, with no alternative imaging modality available, then the use if gadolinium should not be withheld.
PHT uses gadobutrol (Gadovist®) for those with renal impairment. This preparation is macrocyclic and considered a low risk agent for the development of NSF.
It should be used in a dose according to the manufacture (0.1mmol/kg) and a repeat dose should be avoided for a minimum of 7 days.
Gadovist® has been linked to 4 unconfirmed cases of NSF in 30million exposures worldwide – information jointly from the RCR (royal college of radiology) and the PSUR (Periodic Safety Update Reports from Bayer).