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Biomedical subjects

E Schmiedel

Publications and source records attributed to E Schmiedel.

14 recordsLinked to original sources
PubMed1997

[Are nonionic contrast media identical in their tolerability? Results of a double-blind randomized multicenter study with iomeprol and iopromide].

Since a larger number of nonionic contrast media is available for the radiologist, the question arises as to whether they differ in their clinical tolerability. A double-blind, randomized, two-group comparison of phase IV with lomeprol and lopromide was carried out at 6 hospitals involving a total of 1,200 patients with the indication for computed tomography. The contrast media doses and the flow in computed tomography of the skull, thorax, and abdomen were, depending on the centre, between 50 and 200 ml and 0.5 and 3.0 ml/s, respectively. The biostatistical evaluation of adverse events which were probably contrast medium-related produced a highly significant difference between the two contrast media in favor of lomeprol (p = 0.0005). The difference in the reactions of heat, nausea, and vomiting is of clinical relevance as such adverse events may negatively affect the examination procedure and the opacification in spiral computed tomography.

Adult↗
PubMed1996

[Semiquantitative detection of pain and heat sensations in evaluation of contrast media in pelvic/leg angiography. Intraindividual double-blind study with iomeprol 350 and iopentol 350].

The effect on pain and heat sensation of monomere non-ionic contrast media with different osmolality was assessed in a randomized double-blind study. Peripheral angiography was performed in 29 patients who suffered from chronic occlusive vessel disease. The two non-ionic contrast media iomeprol and iopentol were applied intraindividually. The contrast media with an iodine concentration of 350 mg/ml had an osmolality of 618 or 810 mosm/kg. A contrast medium volume of 80 or 90 ml was injected in the abdominal aorta. The mean flow was 13.9 ml/s. The two contrast medium injections were separated by an interval of 10 min. No analgesic premedication was given. The pain and heat intensity was semiquantatively measured using a visual analogue scale ranging from 0 (no heat/pain) to 100 (intractable heat/pain). The median after the first injection was calculated as 40 for iomeprol and 70 for iopentol. The comparison of heat and pain sensations after the second injection showed a less distinct difference with a scale rating of 60 for iomeprol and of 65 for iopentol. The statistical variance was highly significant (p < 0.01) in favor of iomeprol.

Adult↗
PubMed1994

Evaluation of the contrast density of iomeprol.

The recently developed monomeric nonionic contrast medium iomeprol was tested in concentrations of 150, 200, 250, 300, 350, and 400 mgI/ml in open multicentre Phase III studies. The clinical testing was performed in a nonselected patient population (n = 4811); a total of 15,850 injections of the contrast medium was used. All the common radiological methods were used in the study, which was performed in over 150 centres. The contrast density was evaluated as good or satisfactory in 99% of the total patient population. Relevant heat and pain sensations occurred rarely; severe heat and pain were reported only 1.25% and 0.3% of the patients, respectively.

Adolescent↗
PubMed1994

Evaluation of the adverse effects of iomeprol.

The new non-ionic contrast medium iomeprol (Iomeron) 150/200/250/300/350/400 was tested in a non-selected patient population (n = 4811). The aim of the clinical testing, in a very diverse range of radiographical examinations, was to evaluate its tolerance. A high percentage of the patients showed risk factors such as allergic predisposition (22.0%), cardiovascular diseases (45.3%), and kidney disease (15.1%). In addition, high doses of the contrast medium were used, depending on the radiological problem. The proportion of patients over 70 was 19.5%. Iomeprol proved to be an extremely well tolerated nonionic contrast medium. With the exception of nausea, systemic side effects occurred in less than 1% of cases.

Adult↗
PubMed1994

[Iomeprol: results of clinical trials with a new nonionic contrast medium in children].

PURPOSE: To assess the tolerability of the newly developed nonionic contrast medium Iomeprol in pediatric patients. MATERIAL AND METHODS: A total of 438 patients (1 day-17 years) were enrolled in open-label phase III studies with Iomeprol in the most important radiologic, urologic, and cardiologic indications. Iomeprol was tested in five concentrations ranging from isotonic solutions of 150 mg iodine/ml up to 400 mg iodine/ml. Half of the patients were younger than 3 years. RESULTS: Apart from the mostly slight sensations of heat, pain, and taste, the following adverse events were observed independently of a causal relationship to the test compound: vomiting (1.8%), rise in blood pressure (1.8%), and restlessness (1.1%). The respective incidence of all other adverse events was below 1%. CONCLUSION: Iomeprol is a suitable and well-tolerated nonionic contrast medium for use in pediatric examinations.

Adolescent↗
PubMed1993

[A short infusion or a bolus injection of contrast medium in i.v. urography. Comparative density measurements in the kidney pelvic-caliceal system using sequential computed tomography].

The rate of contrast injection during i.v. urography may vary considerably (bolus injection or drip infusion). The effect of 5 rates of injection (6, 12, 18, 36 and 72 ml/min) on the contrast density in the renal collecting system was examined over a period of 30 minutes. Measurements showed an inter-individual difference of more than 200% in each group. The intra-individual variations for different rates of injection were very slight; individual concentration in the kidney for a given dose depends only slightly on the rate of injection. There is no statistically significant improvement in contrast values as a result of a bolus injection. The reduced incidence of side effects justifies the use of bolus injections but pressure injections are unnecessary from a diagnostic point view.

Adult↗
PubMed1993

[Contrast medium nephropathy--a contribution to the reduction of examination risks].

The radiologist is rarely directly confronted with contrast medium-induced renal impairment or even renal failure. In contrast to allergic side effects, the disorders do not become apparent until a few days after the investigation. The relevance of "contrast-medium nephropathy" should not, however, be underestimated: prior contrast medium injections are the initial cause of at least 10% of all cases of acute renal failure. The risk associated with such an investigation can be reduced if the risk factors are known, the patient receives an affective premedication in preparation for the investigation, and if preference is given to non-ionic contrast media.

Contrast Media↗
PubMed1992

[Tolerability of nonionic contrast media--results of a multicenter double blind study].

The aim of the randomized multicentre double-blind study was to establish whether nonionic contrast media differ in tolerability. The controlled comparison was conducted at 4 centres on a total of 798 patients with indication for i.v. DSA and computed tomography. The nonionic contrast media Iopamidol and Iopromide with an iodine content of 300 mg/ml each were studied. The osmolality of both contrast media is virtually identical. Both groups of patients were largely homogeneous in terms of demographic data and case history. The history of allergies was positive in 32.4% of the Iopamidol group and in 32.3% of the Iopromide group. The arithmetic mean of the doses administered to each patients was 148.3 and 149.3 ml, respectively. At all 4 centres there was a higher incidence of adverse events with Iopromide than with Iopamidol. The main differences with regard to pseudo-allergic reactions was the incidence of urticarial reactions, pruritus, nausea, vomiting and coughing. 89 of the 399 patients (22.3%) receiving Iopamidol and 120 of the 399 patients (30.1%) receiving Iopromide experienced pseudo-allergic reactions. The difference between both contrast media is statistically significant (p less than 0.05). There is a 95% certainty that less pseudo-allergic reactions will occur after an Iopamidol injection than after Iopromide. Possible explanations for the differences in tolerability between the two nonionic contrast media with identical osmolality are discussed.

Double-Blind Method↗
PubMed1987

[Pharmacokinetics and tolerance of roentgen contrast media].

The improved tolerance of nonionic contrast media compared with conventional contrast media is mainly due to their lower osmolality and reduced allergoid potential. Tolerance advantages that have been definitely proven are, for example, low-pain contrast medium injection and superior systemic tolerance; side effects of an allergic pattern occur less often. Animals experiments have established that nonionic contrast media exercise a comparatively lower influence on the cardiovascular system. The haemodynamics of pulmonary circulation are less adversely affected on intravenous bolus injection. Reduced potential risk is to be expected especially in cardiac and bronchopulmonary high-risk patients. The reduced nephrotoxicity of nonionic contrast media was definitely established by clinical studies. Further systematic studies will however be required to provide an answer to the question whether this also entails a reduction in the incidence of renal failures induced by contrast media.

Angiography↗