When compared to the CBO 2007 guideline on iodine-containing contrast media, several recommendations have been revised. Overall, the most important changes involve: an improved terminology and PC-AKI definition, a lower threshold of eGFR for hydration indication, another type of hydration (bicarbonate) as a recommended preventive measure and a conservative attitude towards preventive measures for PC-AKI other than hydration. To enhance the implementation of this guideline, changes in the organizational structure are recommended as described in the paragraphs below.

 

Electronic medical records

In the Netherlands, different electronic medical records (EMR) or Hospital Information Systems (HIS) are available from different vendors.

We strongly recommend the same manner of implementation of this guideline, with at least:

  • application forms with eGFR, in combination with a medication order for intravascular contrast medium and a medication order for hydration;
  • in the medication list, an overview of the administrated intravascular contrast media;
  • a query regarding all imaging studies / procedures with intravascular iodine-containing contrast media, eGFR and administered hydration;

 

Hospital-based protocol

For optimal implementation of this guideline a hospital-based protocol describing preventive measures, workflow and responsibilities should be designed. This protocol should be determined by a panel of various experts (including at least a nephrologist, an (vascular) internist, a pharmacist, a cardiologist, a radiologist, a CT or an Angiography technologist, and a quality assurance officer).

 

The referring physician is responsible for analysing and giving notice of the patient’s kidney function, instructing about the patient’s medication, and instructing on the administration of hydration and the patient’s after-care. The decision on contrast administration should be taken by the physician (radiologist, cardiologist, etc.) responsible for the diagnostic or interventional procedure. Actions can be delegated to others according to local rules and protocols. For example, patients at risk can be referred to a nephrology outpatient clinic (or even a “CI-AKI Prevention Clinic”). This has the advantage of a broader expertise and a better data acquisition.

 

Workflow and responsibilities

Responsible person

Action and responsibility

Referring physician

 

Order procedure: contrast enhanced CT (ceCT), angiography / intervention

Discuss alternative imaging with the physician responsible for procedure, if indicated

Inform patient about procedure

Determine eGFR

Assess patient’s hydration status

Assess necessity of preventive measures - hydration

Instruct patient about medication (stop or continue)

 metformin / nephrotoxic drugs

Instruct patient about fluid intake

Arrange hospital admission for hydration

Order hydration in patient record

Physician responsible for the procedure -

Cardiologist / Radiologist / Nuclear Medicine specialist / Radiotherapist

Check order procedure

Discuss alternative imaging with referring physician, if indicated

Check eGFR

Check hydration

Determine procedure protocol and choice of intravascular contrast medium

In case of disagreement, consult referring physician

Order contrast medium in patient record

Referring physician

Before procedure:

Administrate hydration

Record hydration in patient record (type/name, concentration, volume, duration)

After procedure:

check eGFR

If PC-AKI, then treatment and follow-up and record PC-AKI in patient record

Physician responsible for the procedure

Before and during procedure:

Check eGFR and check whether hydration is administered correctly

Check contraindications for CM administration

Administer contrast medium

Record contrast administration in patient record (name, concentration, volume)

 

Exceptions

Emergency patients / procedures

In case of a major life-threatening medical condition requiring rapid decision-making including emergency imaging or intervention (e.g. stroke), the determination of the eGFR can be postponed or the imaging or intervention can be started while the eGFR is being determined in the laboratory. If the possibility exists to wait a short time before commencing diagnosis or intervention, without doing harm to the patient, eGFR should be determined immediately, and if indicated, individualized preventive measures should be taken before the administration of intravascular iodine-containing contrast medium.

 

Kidney transplant recipients

Caution is advised in kidney transplant recipients, because of the lack of good scientific research related to intravascular iodine-containing contrast administration in this group. Considering an alternative imaging modality (e.g. MRI or ultrasound with or without contrast media) is advisable.

 

Optimal nephrology care should always be mandatory. If iodine-containing contrast medium needs to be given in patients with an eGFR < 30 ml/min/1.73m2, preventive hydration is advised, and when necessary individualized to the condition of the patient. For elective examinations, consultation of a nephrologist is recommended.

 

General safety issues

Hydration situation

Optimal nephrology care is mandatory. Dehydration of patients before intravascular contrast administration is undesirable and should be avoided or corrected by giving normal saline or Ringer’s lactate.

 

Alternative methods of investigation

In patients with severe renal failure, the need for the use of contrast medium should be re-examined. Some diagnoses may just as well be made with other potential imaging modalities, like MRI or ultrasound, or by performing an unenhanced study. CO2 angiography may be an alternative to angiography with intravascular iodine-containing contrast medium.

 

Contrast media

The dose of iodine-containing contrast medium should be minimized without compromising the diagnostic aspect of the study/procedure, taking into consideration the indication and the patient’s body weight. In angiography / interventional procedures the amount of contrast medium used is highly variable. There must always be a commitment to use the lowest possible dose of contrast medium.

 

With the development of new generations of CT scanners and angiography equipment, and improved contrast media injection systems, the total volume of contrast medium used for most contrast-enhanced CT /angiography studies has dropped. Also, lower tube voltages allow for lower volumes of CM as lower tube voltage give more signal/ml CM.

 

Consecutive procedures in a patient

Multiple procedures with intravascular iodine-containing contrast medium within 24 hours should be avoided when possible, and only performed when strictly indicated. There are no strict maximum permissible doses of contrast, but in general volumes of over 250-300 cc in a 24-hour period should be avoided.

 

In addition, one must realize that intravascular iodine-containing contrast medium is used in contrast-enhanced CT, PET/CT scans with diagnostic contrast-enhanced CT, and angiography / interventional procedures at the departments of cardiology and radiology.

 

Information and registration

Patient information

Appropriate patient information leaflets should be available, both about the investigational method applied and about the preventive hydration procedure. One should consider having these available in multiple languages.

 

Patient checklist for contrast medium

Consider a checklist for outpatients to check essential information directly before administration of intravascular iodine-containing contrast media. The checklist should include: impaired renal function, dialysis, diabetes mellitus, metformin therapy, and previous hypersensitivity reaction to contrast media.

 

Registration of the contrast medium

Intravascular contrast administration (agent name, concentration, volume) should be recorded in 2 ways:

  1. Patient record
  2. On the CT images

 

The correct information about contrast medium - agent name, concentration and volume in ml - on the CT images will ensure optimal transparency, both in the hospital where the CT images are performed and in any other hospital to which the patient might have been referred.

Autorisatiedatum en geldigheid

Laatst beoordeeld : 01-11-2017

Laatst geautoriseerd : 01-11-2017

The board of the Radiological Society of the Netherlands will determine at the latest in 2023 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.

 

Authotization

The guideline is submitted for authorization to

  • Radiological Society of the Netherlands
  • Netherlands Association of Internal Medicine
  • Dutch Federation of Nephrology
  • Dutch Society of Intensive Care
  • Association of Surgeons of the Netherlands
  • Netherlands Society of Cardiology
  • Netherlands Society for Clinical Chemistry and Laboratory Medicine
  • Netherlands Society of Emergency Physicians
  • Dutch Association of Urology
  • Dutch Society Medical Imaging and Radiotherapy

Initiatief en autorisatie

Initiatief : Nederlandse Vereniging voor Radiologie

Algemene gegevens

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

Doel en doelgroep

Goal of the current guideline

The aim of the Part 1 of Safe Use of Iodine-containing Contrast Media guidelines is to critically review the present recent evidence with the above trend in mind, and try 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 of this guideline

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

A multidisciplinary working group was formed for the development of the guideline in 2014. 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 October 2014 until July 2017.

 

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

  • A.J. van der Molen, radiologist, Leiden University Medical Centre, Leiden (chairman)
  • R.W.F. Geenen, radiologist, Noordwest Ziekenhuisgroep (NWZ), Alkmaar/Den Helder
  • T.H. Pels Rijcken, interventional radiologist, Tergooi, Hilversum
  • H.M. Dekker, radiologist, Radboud University Medical Centre, Nijmegen
  • A.H. van den Meiracker, internist-vascular medicine, Erasmus Medical Centre, Rotterdam
  • E.K. Hoogeveen, nephrologist, Jeroen Bosch Hospital, ‘s-Hertogenbosch
  • H.M. Oudemans - van Straaten, internist-intensive care specialist, Free University Medical Centre, Amsterdam
  • Y.W.J. Sijpkens, nephrologist, Haaglanden Medical Centre, The Hague
  • J. Kooiman, research physician, Leiden University Medical Centre, Leiden
  • C. Cobbaert, clinical chemist, Leiden University Medical Centre (member of advisory board from September 2015)
  • T. Vainas, vascular surgeon, University Medical Centre Groningen (until September 2015)
  • O.R.M. Wikkeling, vascular surgeon, Heelkunde Friesland Groep, location: Nij Smellinghe Hospital, Drachten (from September 2015)
  • P. Danse, interventional cardiologist, Rijnstate Hospital, Arnhem

 

Advisory board

  • K. Prantl, Coordinator Quality & Research, Dutch Kidney Patient Association
  • R. Hubbers, patient representative, Dutch Kidney Patient Association
  • J. Mazel, urologist, Spaarne Gasthuis, Haarlem
  • J. van den Wijngaard, resident in Clinical Chemistry, Leiden University Medical Center
  • A.Y. Demir, clinical chemist, Meander Medical Center, Amersfoort, (member of working group until September 2015)
  • S. Moos, resident in Radiology, HAGA Hospital, The Hague

 

Methodological support

  • I.M. Mostovaya, advisor, Knowledge Institute of Medical Specialists
  • S. Persoon, advisor, Knowledge Institute of Medical Specialists (March 2016 – September 2016)
  • K. Burger, senior advisor, Knowledge Institute of Medical Specialists (until March 2015)
  • A. van Enst, senior advisor, Knowledge Institute of Medical Specialists (from January 2017)
  • J. Boschman, advisor, Knowledge Institute of Medical Specialists (from May 2017)
  • W. Harmsen, advisor, Knowledge Institute of Medical Specialists (from May 2017)

Belangenverklaringen

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.

 

Member

Function

Other offices

Personal financial interests

Personal relationships

Reputation management

Externally financed research

Knowledge-valorisation

Other potential conflicts of interest

Signed

Workgroup

Van der Molen

Chairman, radiologist

Member Contrast Media Safety Committee of the European Society of Urogenital Radiology (unpaid,CMSC meetings are partially funded by CM industry))

None

None

Secretary section of Abdominal Radiology; Radiological Society of the Netherlands (until spring of 2015)

None

None

Receives Royalties for books: Contrast Media Safety, ESUR guidelines, 3rd ed. Springer, 2015

Received speaker fees for lectures on CM safety by GE Healthcare, Guerbet, Bayer Healthcare and Bracco Imaging (2015-2016)

Yes

Geenen

Member, radiologist

Member Contrast Media Safety Committee of the European Society of Urogenital Radiology (unpaid, meetings are partially funded by CM industry)))

None

None

None

None

None

Has been a public speaker during symposia organised by GE Healthcare about contrast agents (most recently in June 2014)

Yes

Dekker

Member, radiologist

None

None

None

None

None

None

None

Yes

Pels Rijcken

Member, interventional radiologist

None

None

None

None

None

None

None

Yes

Danse

Member, cardiologist

Board member committee of Quality, Dutch society for Cardiology (unpaid)

Board member Conference committee DRES (unpaid)

None

None

None

None

None

None

Yes

Oudemans – van Straaten

Member, intensive care medical specialist

Professor Intensive Care

none

None

None

None

None

None

None

Yes

Hoogeveen

Member, nephrologist

Member of Guideline Committee of Dutch Federation of Nephrology

None

None

Member of Guideline Committee of Dutch Society for Nephrology

Grant from the Dutch Kidney Foundation to study effect of fish oil on kidney function in post-MI patients

None

None

Yes

Sijpkens

Member, nephrologist

None

None

None

None

None

None

None

Yes

Van den Meiracker

Member, internist vascular medicine

None

None

None

None

None

None

None

Yes

Cobbaert

Member, physician clinical chemistry

Head of clinical chemistry department in Leiden LUMC.

Tutor for post-academic training of clinical chemists, coordinator/host for the Leiden region

Member of several working groups within the Dutch Society for Clinical Chemistry and member of several international working groups for clinical chemistry

None

None

Member of several working groups within the Dutch Society for Clinical Chemistry and member of several international working groups for clinical chemistry

None

None

None

Yes

Wikkeling

Member, vascular surgeon

None

None

None

None

None

None

None

Yes

Vainas

Member, vascular surgeon

None

None

None

None

None

None

None

Yes

Kooiman

Member, research physician

Resident in department of gynaecology & obstetrics

None

None

None

None

None

None

Yes

Burger

Advisor, Knowledge Institute of Medical Specialists

None

None

None

None

None

None

None

Yes

Mostovaya

Advisor, Knowledge Institute of Medical Specialists

None

None

None

None

None

None

None

Yes

Advisory Board

Prantl

Member, policy maker, Dutch Society of Kidney Patients

None

None

None

None

None

None

None

Yes

Hubbers

Member, patient’s representative, Dutch Society of Kidney Patients

None

None

None

None

None

None

None

Yes

Mazel

Member, urologist

None

None

None

None

None

None

None

Yes

Van den Wijngaard

Member, resident clinical chemistry

Reviewer for several journals (such as American Journal of Physiology)

None

None

None

None

None

None

Yes

Demir

Member, physician clinical chemistry

None

None

None

None

None

None

None

Yes

Inbreng patiëntenperspectief

Patients’ perspective was represented, firstly by membership and involvement in the advisory board of a policy maker and a patients’ representative from the Dutch Kidney Patient Association. Furthermore, an online survey was organized by the Dutch Kidney Patient Association about the subject matter of the guideline. A summary of the results of this survey has been discussed during a working group meeting at the beginning of the guideline development process. Subjects that were deemed relevant by patients were included in the outline of the guideline. The concept guideline has also been submitted for feedback during the comment process to the Dutch Patient and Consumer Federation, who have reported their feedback through the Dutch Kidney Patient Association.

Methode ontwikkeling

Evidence based

Implementatie

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

AGREE

This guideline has been developed conforming to the requirements of the report of Guidelines for Medical Specialists 2.0; 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 suggested by the Dutch Kidney Patient Association, Dutch Society for Emergency Physicians, and Dutch Society for Urology. 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 looked for by cross-referencing 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 the strength of scientific evidence

A) For intervention questions

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/).

 

F1

 

B) For diagnostic, etiological, prognostic or adverse effect questions, the GRADE-methodology cannot (yet) be applied. The quality of evidence of the conclusion is determined by the EBRO method (van Everdingen, 2004)

 

Formulating conclusion

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 organization of healthcare aspects are important to consider when formulating a recommendation. These aspects were discussed in the paragraph Considerations.

 

Formulating recommendations

The recommendations answer the clinical question and were based on the available scientific evidence and the most relevant considerations.

 

Constraints (organization of healthcare)

During the development of the outline of the guideline and the rest of the guideline development process, the organization 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 organization 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 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

Atkins D, Eccles M, Flottorp S, et al. GRADE Working Group. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group. BMC Health Serv Res. 2004 Dec 22;4(1):38.

Van Everdingen JJE, Burgers JS, Assendelft WJJ, et al. Evidence-based richtlijnontwikkeling. Bohn Stafleu van Loghum. Houten, 2004