Severe Acute Adverse Reactions Research Articles

Fasting before contrast-enhanced CT and the incidence of acute adverse reactions: a single-center randomized clinical trial

ObjectivesTo evaluate the effect of eliminating the traditional preparatory fasting policy before contrast-enhanced CT on acute adverse reactions and to identify potential risk factors in a Spanish population sample, since many European patients still experience this unnecessary measure in clinical practice.MethodsOutpatients who underwent non-emergency CT to either 6 h of solid food fasting (control group) or an unrestricted consumption of solids (intervention group). Adverse reactions during contrast media administration and up to 30 min afterward were recorded and their incidence was calculated. Using univariate and multivariate logistic regression analyses, various patient-related and technical factors were evaluated to identify risk factors for nausea and vomiting.ResultsOne thousand one hundred three patients were evaluated, 560 patients in the control group, and 543 patients in the intervention group. Moderate and severe acute adverse reactions were not identified in either group. No statistical difference was found in the overall acute adverse reactions (hypersensitivity and chemotoxicity) incidence between groups (3.21% vs 2.30% p = 0.36). The total incidence of emetic adverse reactions (nausea and vomiting) was significantly lower in the intervention group than in the control group (0.92% vs 2.86% p = 0.02). Multivariate logistic regression analysis revealed that fasting, age, allergies, neurological diseases, and contrast media concentration were independent risk factors for nausea and vomiting.ConclusionUnrestricted food intake did not increase the overall incidence of acute adverse reactions and diminished the incidence of nausea and vomiting.Trial registrationANZCTR, ACTRN12623000071628. Registered 23 January 2023—retrospectively registered, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384985&showOriginal=true&isReview=true.Critical relevance statementThis randomized clinical trial carried out in adults undergoing a non-emergent CT scan demonstrates that fasting as a preparation before a contrast-enhanced CT scan should be discontinued and reserved only for certain specific imaging tests.Key PointsDespite low osmolar CT contrast media becoming ubiquitous, preparatory fasting is still widely practiced.The overall incidence of acute adverse reactions was unchanged after abolishing preparative fasting.Traditional preparatory fasting should be discontinued and reserved only for certain specific imaging tests.Graphical

Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan.

To evaluate the safety of gadobutrol for magnetic resonance imaging in a prospective, non-interventional, post-marketing surveillance in Japan. Gadobutrol was administered in accordance with Japanese prescribing information over a 2-year enrollment period, using a standardized questionnaire to collect information. The primary outcome was the incidence of adverse reactions (ARs) following gadobutrol injection. Questionnaire data were analyzed for 3337 patients (age, 58.1 ± 17.4years [mean±SD]). Gadobutrol was administered at a dose of 0.10 ± 0.02mL/kg body weight. Thirty-three patients were observed to have 42 ARs suspected to be due to gadobutrol, an incidence proportion of 0.99%; 29 ARs were acute (<1h post-injection)-including one case of severe acute AR (0.03%). Patient subpopulations (with hepatic, renal, cardiovascular diseases) did not differ markedly in AR proportions categorized by age, sex, presence of comorbidity, or imaging indication. No cases of nephrogenic systemic fibrosis were reported. Investigators rated images as improved or profoundly improved following gadobutrol injection in 91.1% of examinations. Gadobutrol was well tolerated with a good safety profile in this post-marketing surveillance of a large patient population in Japan.

Increased frequency of acute reactions to iodinated contrast media in cancer patients treated with anti-CTLA-4 immunomodulatory antibodies

Contrast-enhanced computed tomography (CECT) is an indispensable tool in the management of cancer patients. However, this procedure can be complicated by the development of acute adverse reactions (ARs) to iodinated contrast media (ICM). On the basis of the hypothesis that cancer immunotherapy, in particular with immune checkpoint inhibitors, increases the incidence of allergic-like immediate ARs to ICM with respect to “standard” cancer chemotherapy/targeted therapy (CHT) we retrospectively evaluated the incidence of CECT-related immediate ARs in cancer patients undergoing cancer treatments. All patients who underwent at least one CECT scan after starting any cancer treatment between 2006 and 2014 were included in a mono-institutional radiological database. The staff of the Radiology Unit recorded any ARs that occurred within 30 min of the ICM injection and classified them as “allergic-like” or “physiologic” and graded as mild, moderate, or severe according to the American College of Radiology (ACR) Manual on Contrast Media, version 10.1. Fifty-nine of the 3,521 patients included in the database received ipilimumab (Ipi), 75 received cytokines (Cys), and the remaining 3,387 received non-immunologic agents (CHT). Overall, 71 (2%) patients suffered ICM-related ARs. The incidence of ICM-related ARs was higher in Ipi- and Cy-treated patients than in those who received CHT (12%, 5%, and 2%, respectively). Our data show that immunological cancer treatments, particularly Ipi, considerably increase the proportion of patients suffering CECT-related immediate ARs with respect to non-immunologic agents. Although these findings need to be validated in larger prospective studies, they serve as a “wake-up call” for radiologists to closely monitor patients who have previously received cancer immunotherapy with anti-cytotoxic T-lymphocyte antigen-4 antibodies when using ICM in order to reduce the risk of potentially severe immediate ARs.

The Incidence, Classification, and Management of Acute Adverse Reactions to the Low-Osmolar Iodinated Contrast Media Isovue and Ultravist in Contrast-Enhanced Computed Tomography Scanning.

Some epidemiologic surveillance studies have recorded adverse drug reactions to radiocontrast agents. We aimed to investigate the incidence and management of acute adverse reactions (AARs) to Ultravist-370 and Isovue-370 in patients who underwent contrast-enhanced computed tomography (CT) scanning.Data from 137,473 patients were analyzed. They had undergone enhanced CT scanning with intravenous injection of Ultravist-370 or Isovue-370 during the period of January 1, 2006 to December 31, 2012 in our hospital. We investigated and classified AARs according to the American College of Radiology and the Chinese Society of Radiology (CSR) guidelines for iodinated contrast media. We analyzed risk factors for AARs and compared the AARs induced by Ultravist-370 and Isovue-370.Four hundred and twenty-eight (0.31%) patients experienced AARs, which included 330 (0.24%) patients with mild AARs, 82 (0.06%) patients with moderate AARs, and 16 (0.01%) patients with severe AARs (including 3 cases of cardiac arrest and one case of death). The incidence of AARs was higher with Ultravist-370 than with Isovue-370 (0.38% vs 0.24%, P < 0.001), but only for mild AARs (0.32% vs 0.16%, P < 0.001). Analyses on risk factors indicated that female patients (n = 221, 0.43%, P < 0.001), emergency patients (n = 11, 0.51%, P < 0.001), elderly patients aged 50 to 60 years (n = 135, 0.43%, P < 0.001), and patients who underwent coronary computed tomography angiography (CTA) (n = 55, 0.51%, P < 0.001) had a higher risk of AARs. Cutaneous manifestations (50.52%)—especially rash (59.74%)—were the most frequent mild AARs. Cardiovascular manifestations accounted for most moderate and severe AARs (62.91% and 48.28%, respectively). After proper management, the symptoms and signs of 96.5% of the AARs resolved within 24 hours without sequelae.Ultravist-370 and Isovue-370 are safe for patients undergoing enhanced CT scanning. The incidence of AARs is higher with Ultravist-370 than with Isovue-370, but this difference is limited only to the mild AARs. The incidence of AARs could be affected by multiple factors.

Incidence and Severity of Acute Adverse Reactions to Four Different Gadolinium-based MR Contrast Agents

Differences in acute adverse reactions to different gadolinium (Gd)-based contrast agents have not been thoroughly evaluated. We investigated the relationships among the incidence and severity of acute adverse reactions, backgrounds of patients, and 4 types of different Gd-based contrast agents (gadopentetate dimeglumine, gadoteridol, gadoterate meglumine, and gadoxetate disodium). We retrospectively reviewed the radiological records of 10,595 consecutive patients (4,343 female; 6,252 male; mean age, 63.8 ± 14.0 years) who underwent contrast-enhanced magnetic resonance imaging between August 2006 and March 2011. Adverse reactions were classified as mild, moderate, and severe according to the definition of the American College of Radiology. The incidence of adverse reactions were compared on the basis of clinical characteristics and type, dose, and delivery methods of contrast agents by univariate and multivariate logistic regression analyses. The incidence of overall reactions was 0.45% (48/10,595); 45 reactions were mild and three were moderate. No severe reactions were observed. Although the incidence of adverse reactions did not differ significantly between male and female patients, younger individuals were at higher risk for acute adverse reactions. The contrast injection rate and contrast dose were not significantly related to the incidence of adverse reactions. The incidence of adverse reactions was significantly higher for gadoxetate disodium (0.82%) than gadopentetate dimeglumine (0.43%). The incidence of acute adverse reactions elicited by Gd-based contrast agents injection was only 0.45%. Younger age was a risk factor for acute reactions. All 4 agents were found to be safe, although gadoxetate disodium showed a relatively higher incidence of adverse reactions.

Incidence and severity of acute adverse reactions to intravenous iodinated contrast media: 8-year experience in King Chulalongkorn Memorial Hospital

Background: Increasing numbers of acute adverse reactions to contrast media are being seen. Institutional information about incidence and severity of acute adverse reactions to contrast media is essential to inform radiologists of the both common and life-threatening acute adverse reactions encountered. Objectives: We determined the overall, type-specific and severity of acute adverse reactions to intravenous iodinated contrast media at King Chulalongkorn Memorial hospital between January 2002 and December 2009. Methods: This retrospective study reviewed 663 report forms for acute adverse reactions to contrast media among 74,010 intravenous iodinated contrast injections using five types of contrast media including meglumine/sodium ioxitalamate, iohexol, iopamidol, iopromide, and iobitridol. Results: The overall incidence of acute adverse reactions to iodinated contrast media was about 0.9%. Of these 0.8% were minor, and 0.1% were major reactions. The majority of minor reactions were urticaria and the majority of major reactions were facial edema. One contrast-related death was reported. Incidence of acute adverse reactions to nonionic contrast media was 0.58%, and was 4.29 % in the ionic group. The type-specific incidence of acute adverse reactions was 4.29% for meglumine/sodium ioxitalamate, 0.82% for iohexol, 0.29% for iopamidol, 0.65% for iopromide, and 0.25% for iobitridol. Conclusion: Acute adverse reactions to intravenous iodinated contrast media account for less than one percent of injections. The incidence is higher in the ionic contrast media group. The majority of reactions are mild. However, severe reactions can still be encountered and death related to contrast media exist. Keywords: Acute adverse reactions, contrast media, intravenous, iodinated, incidence, severity

Xenotransfusion with canine blood in the feline species: review of the literature.

Xenotransfusion (the transfusion of blood from another species) of canine blood to cats has been historically performed commonly and is still performed nowadays in some countries. Considering the current lack of commercial availability of haemoglobin-based oxygen carrier solution (Oxyglobin), there may be rare occasions when treating an anaemic cat when compatible feline blood cannot be obtained, and where a transfusion with canine blood may need to be considered as a life-saving procedure. This article reviews the published evidence about feline xenotransfusion with canine blood and the results that can be expected with this procedure. Published evidence in a limited number of cases (62 cats) indicates that cats do not appear to have naturally-occurring antibodies against canine red blood cell antigens: compatibility tests prior to the first transfusion did not demonstrate any evidence of agglutination or haemolysis of canine red cells in feline serum or plasma. No severe acute adverse reactions have been reported in cats receiving a single transfusion with canine whole blood. Anaemic cats receiving canine blood are reported to improve clinically within hours. However, antibodies against canine red blood cells are produced rapidly and can be detected within 4-7 days of the transfusion, leading to the destruction of the transfused canine red cells in a delayed haemolytic reaction. The average lifespan of the transfused canine red cells is less than 4 days. Any repeated transfusion with canine blood later than 4-6 days after the first transfusion causes anaphylaxis, which is frequently fatal.

Acute Adverse Reactions to Gadolinium-Based Contrast Agents in CMR: Multicenter Experience With 17,767 Patients From the EuroCMR Registry

The purpose of this study was to assess the frequency, manifestation, and severity of acute adverse reactions associated with administration of several gadolinium-based contrast agents to patients who underwent cardiac magnetic resonance (CMR) imaging in the EuroCMR (European Cardiovascular Magnetic Resonance) Registry multinational and multicenter setting. The frequency, manifestations, and severity of acute adverse reactions associated with gadolinium-based contrast agents in the specific setting of cardiovascular magnetic resonance have not been systematically evaluated yet. This is a multicenter and multinational registry with consecutive enrollment of patients in 45 European centers. During the current observation, 17,767 doses of gadolinium-based contrast agent were administered to 17,767 patients. The mean dose was 25.6 ml (range 5 to 80 ml), which is equivalent to 0.128 mmol/kg (range 0.012 to 0.3 mmol/kg). Thirty acute adverse reactions due to contrast administration occurred (0.17%). All reactions were classified as mild according to the American College of Radiology definition. The most frequent complaints following contrast administration were rashes and hives (9 of 30), followed by nausea (7 of 30), and anxiety (6 of 30). The event rate ranged from 0.06% (linear nonionic agent gadodiamide) to 0.47% (linear ionic agent gadobenate dimeglumine). Interestingly, we also found different event rates between the three main indications for CMR imaging, ranging from 0.1% (risk stratification in suspected coronary artery disease) to 0.42% (viability in known coronary artery disease). The incidence of acute adverse reactions after administration of gadolinium-based contrast in the "off-label" setting of CMR in our population was not different from the incidence in the U.S. Food and Drug Administration-approved general radiology setting. Thus, the off-label use of gadolinium-based contrast in CMR should be regarded as safe concerning the frequency, manifestation, and severity of acute events.

Acute Adverse Reactions to Gadolinium-based Intravenous Contrast Agents for MRI : Retrospective Analysis Using Computed Reporting System

Purpose : To assess the frequency and severity of acute adverse reactions to intravenous administration of gadolinium-based contrast agents using computerized reporting system at a single large academic institution. Materials and Methods : We assessed data from electronic hospital information system from October 2008 to December 2010. Reactions were classified as mild, moderate, or severe. We compared the frequency of adverse reactions among three contrast agents (Gd-BT-DO3A, Gd-DTPA and Gd-EOB-DTPA). Results : The total number of administrated contrast agents was 33,600, and the number of administration of Gd-BT-DO3A, Gd-DTPA and Gd-EOB-DTPA were 20,824 (62%), 10,417 (31%) and 2,359 (7%), respectively. Total 39 adverse reactions were reported accounting for 0.1161% of all administrations. The incidences of adverse reactions were 0.1248% (26/39, 67%) for Gd-BT-DO3A, 0.0768% (8/39, 21%) for Gd-DTPA, and 0.2120% (5/39, 13%) for Gd-EOB-DTPA. The difference of frequencies of adverse reaction among three contrast agents was not significant. Most cases of the adverse effect were mild (35/39, 89.7%). Moderate and severe adverse reactions were encountered in two patients, respectively. Conclusion : Among Koreans, adverse effects were rare, and especially, moderate to severe adverse reactions were much rarer. There was no difference among the frequencies of adverse reactions caused by three different contrast agents.

Evaluation of the acute adverse reaction of contrast medium with high and moderate iodine concentration in patients undergoing computed tomography

The aim of this prospective study was to evaluate and compare acute adverse reactions between contrast medium containing moderate and high concentrations of iodine in patients undergoing computed tomography (CT). A total of 945 patients undergoing enhanced CT were randomly assigned to receive one of two doses of contrast medium. We then prospectively investigated the incidence of adverse reactions. Iopamidol was used as the contrast medium, with a high concentration of 370 mg I/ml and a moderate concentration of 300 mg I/ml. The frequency of adverse reactions, such as pain at the injection site and heat sensation, were determined. Acute adverse reactions were observed in 2.4% (11/458) of the moderate-concentration group compared to 3.11% (15/482) of the high-concentration group; there was no significant difference in incidence between the two groups. Most adverse reactions were mild, and there was no significant difference in severity. One patient in the high-concentration group was seen to have a moderate adverse reaction. No correlation existed between the incidence of adverse reactions and patient characteristics such as sex, age, weight, flow amount, and flow rate. The incidence of pain was not significantly different between the two groups. In contrast, the incidence of heat sensation was significantly higher in the high-concentration group. The incidence and severity of acute adverse reactions were not significantly different between the two groups, and there were no severe adverse reactions in either group.