Veilig gebruik van contrastmiddelen

Initiatief: NVvR Aantal modules: 48

Optimale behandeling van contrastmiddel-extravasatie

Uitgangsvraag

Wat is de optimale behandeling voor contrastmiddel(CM)-extravasatie?

Aanbeveling

Overweeg de volgende behandelingsopties voor extravasatie met CM:

  • Probeer het extravasale CM via een ingebrachte naald op te zuigen.
  • Markeer het getroffen gebied.
  • Gebruik kompressen voor het verlichten van pijn op de injectieplaats.
  • Gebruik pijnstillers.
  • Plaats de getroffen extremiteit boven het niveau van het hart.
Documenteer de contrast-extravasatie en behandeling in het elektronisch patiëntendossier (volume, concentratie, oppervlakte, klinische bevindingen).

Geef de patiënt duidelijke instructies wanneer aanvullende medische zorg moet worden gezocht:

  • Verergering van de symptomen.
  • Huidulceratie.
  • Ontwikkeling van eventuele neurologische of circulatoire symptomen, inclusief paresthesieën.

Geef de patiënt schriftelijke informatie mee.

In geval van ernstige extravasatieschade:

  • Consulteer een plastisch chirurg.
  • Breng de verwijzend arts op de hoogte.

 

Overwegingen

The working group has based this protocol on expert opinions and international guidelines.

At the end of the recommendations suggestions for further reading are given.

 

Extravasations and injuries

One or more of the following signs or symptoms can develop: progressive swelling or pain, altered tissue perfusion as evidenced by decreased capillary refill at any time after the extravasation has occurred, change in sensation in the affected limb, and skin ulceration or blistering. It is important to note that initial symptoms of a compartment syndrome may be relatively mild (such as limited to the development of focal paraesthesia).

 

Most extravasations result in minimal swelling or erythema, with no long-term sequelae.

Few extravasations result in significant tissue damage, i.e. severe skin necrosis and ulceration. Compartment syndrome may be seen associated with extravasation of large volumes and after extravasation of relatively small volumes in less capacious areas.

Extravasation can occur during hand or power injection.

 

The risk of extravasation is much less with GBCA injections.

 

Risk factors

Location of extravasation:

Less capacious areas (such as over the ventral or dorsal surfaces of the wrist) – higher risk

More capacious areas (such as upper arm) – lower risk

 

Volume of extravasation:

Large volume of contrast medium – higher risk

 

Inability to communicate:

Infants, young children, and unconscious and debilitated patients

 

Management

  • Recognition of the extravasation, stop infusion of contrast media immediately.
  • Try to aspirate the extravasated contrast medium through the inserted needle.
  • Mark off affected area.
  • Consultation of a radiologist.
  • Surgical consultation (plastic surgeon) should be obtained whenever there is concern for a severe injury. Alternative: consultation of a physician in the emergency department.
  • Clear instructions should be given to the patient to be aware of alarming symptoms.
  • Appropriate patient information leaflets should be available. One should consider having these available in multiple languages.
  • Appointments for follow up, if necessary.
  • The referring physician should be notified.
  • Record contrast extravasation and treatment in patient record (name, volume, concentration, area, clinical findings).
  • Record names of all professionals involved in the patient management in patient record.
  • Report contrast extravasation as a complication in the local reporting system.

Treatment

Non-severe extravasation injury:

  • Use of cold of warm compresses, helpful for relieving pain at the injection site.
  • Use of cold compresses, mainly helpful for relieving pain at the injection site.
  • Use of warm compresses, helpful in improving absorption of the extravasation as well as in improving blood flow, particularly distal to the site.
  • Use of pain medication (analgesics).
  • Elevation of the affected extremity above the level of the heart to decrease capillary hydrostatic pressure and thereby promote resorption of extravasated fluid is recommended.
  • Clear instructions should be given to the patient to seek additional medical care, should there be any worsening of symptoms, skin ulceration, or the development of any neurologic or circulatory symptoms, including paraesthesias.

Severe extravasation injury:

  • Surgical consultation (plastic surgeon).
  • Clear instructions should be given to the patient about the follow-up.

Onderbouwing

Extravasation of intravascular (intravenous or intra-arterial) injected contrast (hand or power injection) is a well-recognized complication of contrast enhanced imaging studies (CT and MRI and US), angiography and interventions. Currently the clinical consequences and most optimal management is a matter of debate.

Not applicable. There were no studies investigating the research question.

To answer our clinical question a systematic literature analysis was performed.

 

P (Patient): Patients with extravasation after intravascular contrast Administration.

I (Intervention): Contrast aspiration, cooling of area of contrast extravasation, fasciotomy, necrotectomie, dilution, flushing with sterile water, application of ice, anti-inflammatory agents, corticosteroid, removal catheter, elevation of the affected limb / extremity, cold compresses, Plastic Surgery Review, monitoring the patient, surgical consultation.

C (Comparison): Conservative treatment or comparison of interventions above.

O (Outcomes): Rhabdomyolysis, tissue necrosis, long term injury / disability, compartment syndrome, pain, swelling and ulceration.

 

Relevant outcome measures

The working group considered compartment syndrome, tissue necrosis, and permanent or long-term injury or disability critical outcome measures for the decision making process, and location and volume of extravasation, pain, swelling, ulceration important outcomes for the decision making process.

 

Methods

The databases Medline (OVID), Embase and the Cochrane Library were searched from 1st of January 1996 to 7th of February 2018 using relevant search terms for systematic reviews (SRs), randomized controlled trials (RCTs) and observational studies (OBS).

 

The literature search procured 480 hits: 1 SR, 41 RCTs and 438 OBS. Based on title and abstract a total of 22 studies were selected. After examination of full text a total of all studies were excluded and 0 studies definitely included in the literature summary.

  1. American College of Radiology. ACR Manual on contrast media, v10.3. Available at: www.acr.org/Clinical-Resources/Contrast-Manual. Accessed: 11 July 2019.
  2. European Society of Urogenital Radiology Contrast Media Safety Committee. ESUR Guidelines on contrast safety, v10. Available at: www.esur-cm.org. Accessed: 11 July 2019.
  3. Behzadi AM, Farooq V, Newhouse JH, Prince MR. MRI and CT contrast media extravasation: a systematic review. Medicine (Baltimore) 2018; 97: e0055.
  4. Ding S, Meystre NR, Campeanu C, Gullo G. Contrast media extravasations in patients undergoing computerized tomography scanning: a systematic review and meta-analysis of risk factors and interventions. JBI Database System Rev Implement Rep 2018; 16: 87-116.
  5. Hrycyk J, Heverhagen JT, Böhm I. What you should know about prophylaxis and treatment of radiographic and magnetic resonance contrast medium extravasation. Acta Radiol 2019; 60: 496-500.
  6. Hwang EJ, Shin CI, Choi YH, Park CM. Frequence, outcome and risk factors for contrast media extravasation in 142,651 contrast-enhanced CT scans. Eur Radiol 2018; 28: 5368-5375
  7. Ko CH, Tay SY, Chang HC, Chan WP. Large-volume iodinated contrast medium extravasation: low frequency and good outcome after conservative management in a single-centre cohort of more than 67,000 patients. Eur Radiol 2018;28: 5376-5383.
  8. Mandlik V, Prantl L, Schreyer AG. Contrast media extravasation in CT and MRI: a literature review and strategies for therapy. RöFo Fortschr Röntgenstr 2019; 191: 25–32.

Table Exclusion after reading the full text

Author and Year

Reasons for exclusion

Bellin 2002

Does not fulfil selection criteria. No control group. Descriptive.

Botany 2010

Does not fulfil selection criteria. No control group. Descriptive.

Cochran 2002

Does not fulfil selection criteria. No control group. Descriptive.

Cohan 1997

Does not fulfil selection criteria. No control group. Descriptive.

Conner 2017

Does not fulfil selection criteria. No control group. Descriptive.

Conner 2017

Does not fulfil selection criteria. No control group. Descriptive.

Davenport 2012

Does not fulfil selection criteria. No control group. Descriptive.

Ding 2018

Does not discuss treatment of extravasation

Ding 2018

Does not fulfil selection criteria. No control group. Descriptive.

Earhart 2011

Does not fulfil selection criteria. No control group. Descriptive.

Fallscheer 2007

Does not fulfil selection criteria. No control group. Descriptive.

Kim 2017

Does not fulfil selection criteria. No control group. Descriptive.

Kim 2017

Does not fulfil selection criteria. No control group. Descriptive.

Nicola 2016

Does not fulfil selection criteria. No control group. Descriptive.

Rose 2015

Does not fulfil selection criteria. No control group. Descriptive.

Schaverien 2008

Does not fulfil selection criteria. No control group. Descriptive.

Schummer 2010

Does not fulfil selection criteria. No control group. Descriptive.

Sonis 2017

Does not fulfil selection criteria. No control group. Descriptive.

Sonis 2017

Does not fulfil selection criteria. No control group. Descriptive.

Sum 2006

Does not fulfil selection criteria. No control group. Descriptive.

Tonolini 2012

Does not fulfil selection criteria. No control group. Descriptive.

Tonolini 2016

No comparison therapies. Letter tot the editor on the occasion of Nicola 2016

Tsai 2007

Does not fulfil selection criteria. No control group. Descriptive.

Vandeweyer 2000

Does not fulfil selection criteria. No control group. Descriptive.

Wang 2007

Does not fulfil selection criteria. No control group. Descriptive.

Wilson 2011

Does not fulfil selection criteria. No control group. Descriptive.

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 24-06-2020

Laatst geautoriseerd  : 24-06-2020

Geplande herbeoordeling  : 01-01-2025

Validity

The board of the Radiological Society of the Netherlands will determine at the latest in 2024 if this guideline (per module) is still valid and applicable. If necessary, a new working group will be formed to revise the guideline. The validity of a guideline can be shorter than 5 years, if new scientific or healthcare structure developments arise, that could be seen as a reason to commence revisions. The Radiological Society of the Netherlands is considered the keeper of this guideline and thus primarily responsible for the actuality of the guideline. The other scientific societies that have participated in the guideline development share the responsibility to inform the primarily responsible scientific society about relevant developments in their field.

 

Initiative

Radiological Society of the Netherlands

 

Authorization

The guideline is submitted for authorization to:

  • Association of Surgeons of the Netherlands
  • Dutch Association of Hospital Pharmacists
  • Dutch Federation of Nephrology
  • Dutch Society for Allergology and Clinical Immunology
  • Dutch Society for Dermatology and Venereology
  • Dutch Society of Intensive Care
  • Netherlands Association of Internal Medicine
  • Netherlands Society of Cardiology
  • Netherlands Society of Emergency Physicians
  • Netherlands Society of Intensive Care
  • Radiological Society of the Netherlands

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Radiologie
Geautoriseerd door:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose
  • Nederlandse Vereniging van Spoedeisende Hulp Artsen
  • Nederlandse Vereniging voor Cardiologie
  • Nederlandse Vereniging voor Dermatologie en Venereologie
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging van Ziekenhuisapothekers
  • Nederlandse Vereniging voor Klinische Chemie en Laboratoriumgeneeskunde
  • Nederlandse Vereniging voor Intensive Care
  • Patiëntenfederatie Nederland
  • Nederlandse Vereniging voor Allergologie en Klinische Immunologie
  • Nederlandse Federatie voor Nefrologie

Algemene gegevens

General Information

The guideline development was assisted by the Knowledge Institute of the Federation Medical Specialists (www.kennisinstituut.nl) and was financed by the Quality Funds for Medical Specialists (Stichting Kwaliteitsgelden Medisch Specialisten: SKMS).

Doel en doelgroep

Goal

The aim of the Part 2 of Safe Use of Contrast Media guidelines is to critically review the present recent evidence with the above trend in mind and tries to formulate new practical guidelines for all hospital physicians to provide the safe use of contrast media in diagnostic and interventional studies. The ultimate goal of this guideline is to increase the quality of care, by providing efficient and expedient healthcare to the specific patient populations that may benefit from this healthcare and simultaneously guard patients from ineffective care. Furthermore, such a guideline should ideally be able to save money and reduce day-hospital waiting lists.

 

Users

This guideline is intended for all hospital physicians that request or perform diagnostic or interventional radiologic or cardiologic studies for their patients in which CM are involved.

Samenstelling werkgroep

Working group members

A multidisciplinary working group was formed for the development of the guideline in 2016. The working group consisted of representatives from all relevant medical specialization fields that are involved with intravascular contrast administration.

 

All working group members have been officially delegated for participation in the working group by their scientific societies. The working group has developed a guideline in the period from May 2016 until July 2019.

 

The working group is responsible for the complete text of this guideline.

 

Working group

Brummer I., emergency physician, Treant Healthcare Group, Emmen

de Geus H.R.H., internist-intensivist, Erasmus Medical Centre, Rotterdam

de Monchy J.G.R., allergologist, DC-Klinieken, Amsterdam

Dekker H.M., radiologist, Radboud University Medical Centre, Nijmegen

Dekkers I.A., clinical epidemiologist and radiologist in training, Leiden University Medical Centre, Leiden

Geenen R.W.F., radiologist, Noordwest Ziekenhuisgroep (NWZ), Alkmaar

Gotte M., cardiologist, Free University Medical Centre, Amsterdam (from July 2018)

Kardaun S.H., dermatologist, University Medical Centre Groningen, Groningen (until March, 2018)

Leiner T., radiologist, University Medical Centre Utrecht, Utrecht (until November 2018)

van der Molen A.J., radiologist, Leiden University Medical Centre, Leiden (chairman)

van der Putten K., nephrologist, Tergooi, Hilversum

van der Vlugt M., cardiologist, Radboud University Medical Centre, Nijmegen (until April 2018)

Wikkeling O.R.M., vascular surgeon, Heelkunde Friesland Groep, location: Nij Smellinghe Hospital, Drachten

Zielhuis S.W., hospital pharmacist, Medical Centre Leeuwarden, Leeuwarden

 

Methodological support

Buddeke J., advisor, Knowledge Institute of the Federation Medical Specialists (from April 2018)

Harmsen W., advisor, Knowledge Institute of the Federation Medical Specialists (from April 2018)

Mostovaya I.M., senior advisor, Knowledge Institute of the Federation Medical Specialists

Belangenverklaringen

Conflicts of interest

The working group members have provided written statements about (financially supported) relations with commercial companies, organisations or institutions that are related to the subject matter of the guideline. Furthermore, inquiries have been made regarding personal financial interests, interests due to personal relationships, interests related to reputation management, interest related to externally financed research and interests related to knowledge valorisation. The statements on conflict of interest can be requested at the administrative office of the Knowledge Institute of Medical Specialists and are summarised below.

 

Last name

Function

Other positions

Personal financial interests

Personal relations

Reputation management

Externally financed research

Knowledge valorisation

Other interests

Signed

Brummer

Emergency physician
Treant zorggroep location Emmen and Stadskanaal

None

None

None

None

None

None

None

February 23rd, 2018

De Geus

Internist-Intensivist Erasmus MC Rotterdam

None

None

None

None

None

None

None

March 31st, 2016

Dekker

Radiologist

None

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

July 10th, 2016

Dekkers

Radiologist in training and PhD-candidate

None

None

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

July 8th, 2016

Geenen

Radiologist

Member of commission prevention of PC-AKI

None

None

None

None

None

Has held several presentation about contrast media on invitation (GE, BAYER)

March 25th, 2016

Kardaun

Dermatologist – researcher Universitair Medisch Centrum Groningen: unpaid

Replacing dermatologist in clinical practice - unpaid
Member of scientific advisory board of Lareb (Dutch center for pharmacovigilance): unpaid

None

None

None

None

None

None

February 24th, 2016

Roodheuvel

Emergency physician

Instructor OSG/VvAA for courses on echography – paid position

Member of department for burn treatment – unpaid.

None

None

None

None

None

None

December 21st, 2015

Van der Molen

Chairman
Radiologist at LUMC

None

None

None

None

None

Not applicable

One-off royalties Springer Verlag (2014)
Reference work Safety of contrast medicine
One-off payment by Guerbet for (2014)
reference card management of CM reactions (educative material)

Incidental payments for presentations or being day chairman at contrast safety congress (2016 Netherlands + Europe
all firms: GE, Guerbet, Bracco, Bayer

September 6th, 2016

Van der Putten

Internist nephrologist

None

None

None

None

None

None

None

October 14th, 2015

Van der Vlugt

Cardiologist

None

None

None

Chairman of the working group Cardiac MRI & CT and Nuclear imaging of the Netherlands Society of Cardiology

None

None

None

March 1st, 2016

Wikkeling

Vascular surgeon

None

None

None

None

None

None

Not applicable

July 19th, 2016

Zielhuis

Hospital pharmacist

None

In the past (2013-2015) has participated in an advisory panel on expensive medication for the companies AbbVie and Novartis. Has received an expense allowance for this. Both forms do not produce contrast media that this guideline is about. Currently not active in an advisory panel.

None

None

None

None

None

January 8th, 2016

Inbreng patiëntenperspectief

Input of patient’s perspective

It was challenging to find representation for the patient’s perspective, since the guideline does not discuss a specific group of patients with a disease. The Dutch Kidney Patients Association was invited to participate in an advisory board to the working group, but declined since this subject was not specific enough for them to give adequate input; The Dutch Kidney Patients Association did provide written feedback for specific modules during the commentary phase. The Dutch Kidney Patients Association and the Patient Federation of the Netherlands was invited to participate in the invitational conference in which the framework of the guideline was discussed. Furthermore, the concept guideline has been submitted for feedback during the comment process to the Patient Federation of the Netherlands and the Dutch Kidney Patient Association.

Methode ontwikkeling

Evidence based

Implementatie

Implementation

In the different phases of guideline development, the implementation of the guideline, and the practical enforceability of the guideline were taken into account. The factors that could facilitate or hinder the introduction of the guideline in clinical practice have been explicitly considered. The implementation plan can be found with the Related Products. Furthermore, quality indicators were developed to enhance the implementation of the guideline. The indicators can also be found with the Related Products.

Werkwijze

Methodology

AGREE

This guideline has been developed conforming to the requirements of the report of Guidelines for Medical Specialists 2.0 by the advisory committee of the Quality Counsel (www.kwaliteitskoepel.nl). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreetrust.org), a broadly accepted instrument in the international community and on the national quality standards for guidelines: “Guidelines for guidelines” (www.zorginstituutnederland.nl).

 

Identification of subject matter

During the initial phase of the guideline development, the chairman, working group and the advisor inventory the relevant subject matter for the guideline. Furthermore, an Invitational Conference was organized, where additional relevant subjects were discussed. A report of this meeting can be found in Related Products.

 

Clinical questions and outcomes

During the initial phase of guideline development, the chairman, working group and advisor identified relevant subject matter for the guideline. Furthermore, input was acquired for the outline of the guideline during an Invitational Conference. The working group then formulated definitive clinical questions and defined relevant outcome measures (both beneficial land harmful effects). The working group rated the outcome measures as critical, important and not important. Furthermore, where applicable, the working group defined relevant clinical differences.

 

Strategy for search and selection of literature

For the separate clinical questions, specific search terms were formulated and published scientific articles were sought after in (several) electronic databases. Furthermore, studies were scrutinized by cross-referencing for other included studies. The studies with potentially the highest quality of research were looked for first. The working group members selected literature in pairs (independently of each other) based on title and abstract. A second selection was performed based on full text. The databases, search terms and selection criteria are described in the modules containing the clinical questions.

 

Quality assessment of individual studies

Individual studies were systematically assessed, based on methodological quality criteria that were determined prior to the search, so that risk of bias could be estimated. This is described in the “risk of bias” tables.

 

Summary of literature

The relevant research findings of all selected articles are shown in evidence tables. The most important findings in literature are described in literature summaries. When there were enough similarities between studies, the study data were pooled.

 

Grading quality of evidence and strength of recommendations

The strength of the conclusions of the scientific publications was determined using the GRADE-method. GRADE stands for Grading Recommendations Assessment, Development and Evaluation (see http://www.gradeworkinggroup.org/) (Atkins, 2004).

 

GRADE defines four gradations for the quality of scientific evidence: high, moderate, low or very low. These gradations provide information about the amount of certainty about the literature conclusions. (http://www.guidelinedevelopment.org/handbook/).

 

Formulating conclusions

For diagnostic, etiological, prognostic or adverse effect questions, the evidence was summarized in one or more conclusions, and the level of the most relevant evidence was reported. For intervention questions, the conclusion was drawn based on the body of evidence (not one or several articles). The working groups weighed the beneficial and harmful effects of the intervention.

 

Considerations

Aspects such as expertise of working group members, patient preferences, costs, availability of facilities and organisation of healthcare aspects are important to consider when formulating a recommendation. These aspects were discussed in the paragraph Considerations.

 

Formulating recommendations

The recommendation answers the clinical question and was based on the available scientific evidence and the most relevant considerations.

 

Constraints (Organisation of healthcare)

During the development of the outline of the guideline and the rest of the guideline development process, the Organisation of healthcare was explicitly taken into account. Constraints that were relevant for certain clinical questions were discussed in the Consideration paragraphs of those clinical questions. The comprehensive and additional aspects of the Organisation of healthcare were discussed in a separate chapter.

 

Development of quality indicators

Internal (meant for use by scientific society or its members) quality indicators are developed simultaneously with the guideline. Furthermore, existing indicators on this subject were critically appraised; and the working group produces an advice about such indicators. Additional information on the development of quality indicators is available by contacting the Knowledge Institute for the Federation Medical Specialists. (secretariaat@kennisinstituut.nl).

 

Knowledge Gaps

During the development of the guideline, a systematic literature search was performed the results of which help to answer the clinical questions. For each clinical question the working group determined if additional scientific research on this subject was desirable. An overview of recommendations for further research is available in the appendix Knowledge Gaps.

 

Comment- and authorisation phase

The concept guideline was subjected to commentaries by the involved scientific societies. The commentaries were collected and discussed with the working group. The feedback was used to improve the guideline; afterwards the working group made the guideline definitive. The final version of the guideline was offered for authorization to the involved scientific societies and was authorized.

 

References

Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182(18):E839-E842.

Medisch Specialistische Richtlijnen 2.0. Adviescommissie Richtlijnen van de Raad Kwalitieit, 2012. Available at: http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html.

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available at: http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.

Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106-10.  Erratum published in: BMJ 2008;336(7654).

Ontwikkeling van Medisch Specialistische Richtlijnen: stappenplan. Kennisinstituut van Medisch Specialisten.

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