Consent to Intravenous Injection of Contrast Material: Gadolinium

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First Name: Middle: Last:
Date: xx/xx/xxxx
Time:
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I hereby authorize the designated DIA Radiologist and his/her assistants or technologists to inject the contrast material within my body for the following procedure:

I certify that no guarantee or assurance has been made to me covering the results of this procedure.

I fully understand the purpose and nature of this procedure. I understand the procedure’s potential risks and complications (listed below) and confirm that I am undergoing this procedure of my own free will. I certify that all my questions in regard to this procedure were answered to my fullest satisfaction. I confirm that I have received no guarantees as to the results that my be obtained from this procedure.

I do hereby sign and consent to pay any charges incurred for this procedure. In the occurrence that the insurance carrier denies my eligibility or coverage for these services, I will be fully responsible for the remittance of all the fees.

Gadolinium-Based Contrast Media – Adverse Reacations
(Statistical Source: American College of Radiology/Manual on Contrast Media)

The contrast agent you will receive is FDA-approved and used routinely for MRI exams. It contains a material called gadolinium.

  • The frequency of all adverse events after an injection ranges from 0.07-2.4 percent. The vast majority of these reactions are mild, including colness at the injection site, nausea with or without vomiting, headache, warmth or pain at the injection site, paresthesias, dizziness, and itching.
  • Allergic responses are very unusual and vary in frequency from 0.04-0.7 percent. A rash, hives, or urticaria are the most frequent of this group, and very rarely there may be bronchospasm. Severe, life-threatening anaphylactoid reactions are exceedingly rare (0.001-0.01 percent).
  • Insertion of the needle to administer gadolinium may cause minor pain, bruising and/or infection at the injection site.
  • People with moderate to advanced kidney failure who receive gdolinium are at risk of developing Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). This is a rare fibrosing condition of the skin and organs. The clinical course of NSF/NFD is progressive and may be fatal. If you want to read further on this topic, please notify DIA staff. If you have moderate to advanced kidney failure and receive gadolinium, the risk of developing NSF/NFD is one to five percent, therefore DIA requests kidney function screening before you receive gadolinium contrast for your MRI, as recommended by the American College of Radiology (see below).
American College of Radiology Screening Recommendations for Gadolinium-Based MR Contrast Agents, Renaul Disease Patients, and NSF

It is recommended that prior to elective Gadolinium Based MR Contrast Agent (GBMCA) administration, a recent (e.g. last 6 weeks) Glomerular Filtration Rate (GFR) assessment is reviewed for patients with a history of:

1. Renal disease (including solitary kidney, renal transplant, renal tumor)
2. Age >60
3. History of Hypertension
4. History of Diabetes
5. History of severe hepatic disease/liver transplant/pending liver transplant. For patients in this category only, it is recommended that the patient’s GFR assessment be nearly contemporaneous with the MR examination for which the GBMCA is to be administered.

Please notify a DIA radiologist or technologist if you are allergic to gadolinium, have any kidney problems, or experience any of these or other side effects.

I have read (or have had it read to me) this consent form and, by clicking on the consent box, confirm to my complete understanding of its content.

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