Shin Schmerz Thrombophlebitis

Dexamethasone in Adults with Bacterial Meningitis

Shin Schmerz Thrombophlebitis Dexamethasone in Adults with Bacterial Meningitis — NEJM Original Article. Dexamethasone in Adults with Bacterial Meningitis. Jan de Gans, Ph.D., and Diederik van de Beek, M.D., for the European Dexamethasone in Adulthood.


Original Article. Dexamethasone in Adults with Bacterial Meningitis. Jan de Gans, Ph.D., and Diederik van de Beek, M.D., for the European Dexamethasone in Adulthood.

Jan de Gans, Ph. N Engl J Med ; Mortality and morbidity rates are high among adults with acute bacterial meningitis, especially those with pneumococcal meningitis. In studies of bacterial meningitis in animals, adjuvant treatment with corticosteroids has beneficial effects. Full Text of Background We conducted a prospective, randomized, double-blind, multicenter trial of adjuvant treatment with dexamethasone, as compared shin Schmerz Thrombophlebitis placebo, in adults with acute bacterial meningitis, shin Schmerz Thrombophlebitis.

Dexamethasone 10 mg or placebo was administered 15 to 20 minutes before or with the first dose of antibiotic and was given every 6 hours for four days.

The primary outcome measure was the score on the Glasgow Outcome Scale at eight weeks a score of 5, shin Schmerz Thrombophlebitis, indicating a favorable outcome, vs. A subgroup analysis according to the causative organism was performed. Analyses were performed on an intention-to-treat basis. Full Text of Methods A total of patients were randomly assigned to a treatment group: The base-line characteristics of the two groups were similar.

Treatment with dexamethasone was associated with a reduction in the risk of an unfavorable outcome relative risk, 0.

Treatment with dexamethasone was also associated with a reduction in mortality relative risk of death, 0. Among the shin Schmerz Thrombophlebitis with pneumococcal meningitis, there were unfavorable outcomes in 26 percent of the dexamethasone group, as compared with 52 percent of the placebo group relative risk, 0.

Gastrointestinal bleeding occurred in two patients in the dexamethasone group and in five patients Krampfadern an den Beinen können wir tun, the placebo group. Full Text of Results Early treatment with dexamethasone improves the outcome in adults with acute bacterial meningitis and does not increase the risk of gastrointestinal bleeding.

Full Text of Discussion The mortality rate among adults with acute bacterial meningitis and the frequency of neurologic sequelae among those who survive are high, especially among patients with pneumococcal meningitis. Many controlled trials have been performed to determine whether adjuvant shin Schmerz Thrombophlebitis therapy is beneficial in children with acute bacterial meningitis, shin Schmerz Thrombophlebitis. The results, however, do not point unequivocally to a beneficial effect.

A meta-analysis of randomized controlled trials performed since showed a beneficial effect of adjunctive dexamethasone therapy in terms of severe hearing loss in children with Haemophilus influenzae type b meningitis and suggested a protective effect in those with pneumococcal meningitis if the drug was given before or with parenteral antibiotics.

One large, prospective, randomized trial neither placebo-controlled nor double-blind showed a benefit of dexamethasone therapy in a subgroup of patients with pneumococcal meningitis. Patients referred to one of the participating centers listed in the Appendix were eligible for the study if they were 17 years of age or older, had suspected meningitis in combination with cloudy cerebrospinal fluid, bacteria in cerebrospinal fluid on Gram's staining, or a cerebrospinal fluid leukocyte count of more than per cubic millimeter, shin Schmerz Thrombophlebitis.

The study protocol was approved by the institutional review board of each participating hospital. All patients or their legally authorized representatives gave written informed consent before enrollment. Patients were enrolled between June and December The study was designed, shin Schmerz Thrombophlebitis, conducted, and analyzed independently of any companies. Patients were randomly assigned to receive dexamethasone sodium phosphate Oradexonat a dose of 10 mg given every six hours intravenously for four days, or placebo that was identical in appearance to the active drug.

The study medication was given 15 to 20 minutes before the parenteral administration of antibiotics. After the interim analysis, the protocol was amended to allow administration of the study medication with the antibiotics. Balanced treatment assignments within each hospital were achieved with the use of a computer-generated list of random numbers in blocks of six.

The code was not broken until the last patient to be enrolled had completed eight weeks of follow-up. Treatment assignments were concealed from all investigators, but in an emergency, investigators had access to the sealed, opaque envelopes containing the assignments; two emergencies occurred. Patients were initially treated with amoxicillin 2 g given intravenously every four hours for 7 to 10 days, depending on the cause of shin Schmerz Thrombophlebitis meningitis and the clinical response, shin Schmerz Thrombophlebitis.

This regimen was based on the available data on susceptibility to antibiotics of cerebrospinal fluid isolates in the Netherlands. Routine examination and cultures of blood and cerebrospinal fluid were performed before the initiation of antibiotic treatment, shin Schmerz Thrombophlebitis. On day five, shin Schmerz Thrombophlebitis, routine blood chemical tests were performed, including measurement of glucose and hemoglobin levels, shin Schmerz Thrombophlebitis.

As part of routine surveillance, the Netherlands Reference Laboratory for Bacterial Meningitis performed in vitro testing of cerebrospinal fluid isolates for susceptibility to penicillin. The primary outcome measure was the score on the Glasgow Outcome Scale eight weeks after randomization, as assessed by the patient's physician. A score of 1 indicates death; 2, a vegetative state the patient is unable to interact with the environment ; 3, severe disability the patient is unable to live independently but can follow commands ; 4, shin Schmerz Thrombophlebitis, moderate disability the patient is capable of living independently but unable to return to work or school ; and 5, shin Schmerz Thrombophlebitis or no disability the patient is able to return to work or school.

The Glasgow Outcome Scale has frequently been used in trials involving stroke and other brain injuries. It is a well-validated scale with good interobserver agreement. Secondary outcome measures were death, focal neurologic abnormalities defined as aphasia, cranial-nerve palsy, monoparesis, hemiparesis, and severe ataxiahearing loss, gastrointestinal bleeding clinically relevant bleeding with a decreased serum hemoglobin levelfungal infection, herpes zoster, and hyperglycemia a blood glucose level higher than mg per deciliter [8.

Audiologic examination was performed in patients with clinical hearing loss. Subgroup analyses were performed for patients with prospectively defined causes of meningitis: Shin Schmerz Thrombophlebitis meningitidis, Streptococcus pneumoniae, other bacteria, and an unidentified cause indicated by a negative cerebrospinal fluid culture. Calculation of the required sample size was based on the assumption that dexamethasone would reduce the proportion of patients with an unfavorable outcome from 40 to 25 percent.

With a two-sided test, an alpha level of 0. The analysis of outcomes was performed on an intention-to-treat basis with the use of a last-observation-carried-forward procedure. An additional analysis in shin Schmerz Thrombophlebitis data for patients lost to follow-up were defined as missing was also performed. The results of these two analyses were similar. Proportions of patients in the two groups were compared with Fisher's exact test.

Two-tailed P values of less than 0. Parametric and nonparametric values were tested with Student's t-test and the Mann—Whitney U test, respectively. The results are expressed as relative risks for the dexamethasone group as compared shin Schmerz Thrombophlebitis the placebo group, with a relative risk of less than shin Schmerz Thrombophlebitis. Logistic-regression analysis of base-line variables sex; age; duration of symptoms; presence or absence of seizures, coma, and hypotension on admission; results of blood culture; cerebrospinal fluid white-cell count; and causative organism was performed to identify risk factors for an adverse outcome other than the group assignment.

Ninety-five percent confidence intervals, calculated with the use of Confidence Interval Analysis, are reported. A three-member independent data-monitoring committee performed an interim analysis after patients shin Schmerz Thrombophlebitis been enrolled.

The study would have been stopped if any significant differences in efficacy or safety had been found. On January 10,the data-monitoring committee recommended early termination of the trial because the enrollment rate was too slow for completion within a reasonable time. The committee subsequently reconsidered its decision and recommended that the trial be restarted if the enrollment rate could be improved.

To increase the enrollment rate, two amendments of the protocol were made. First, the protocol was amended to allow administration of the study medication with the antibiotics.

This decision was based on the results of a meta-analysis of trials of dexamethasone in children with acute bacterial meningitis. This change was made because of the participation shin Schmerz Thrombophlebitis centers in countries where highly resistant pneumococcal strains are more common than they are in the Netherlands. A total of patients were randomly assigned to shin Schmerz Thrombophlebitis study group: Two patients one in each group did not meet the inclusion criteria because they were too young, shin Schmerz Thrombophlebitis.

Seven patients in the dexamethasone group and shin Schmerz Thrombophlebitis in the placebo group each met one exclusion criterion; one patient in the dexamethasone group met two exclusion criteria. Eleven patients in each group were withdrawn from treatment early, but all patients received the assigned treatment, at least initially Figure 1 Figure 1 Random Assignment to Treatment, Withdrawal from Treatment, and Follow-up among Adults with Bacterial Meningitis.

Four patients were withdrawn because they did not meet the inclusion criteria three in the dexamethasone group and one in the placebo groupand five because of adverse events four in the dexamethasone group and one in the placebo group, shin Schmerz Thrombophlebitis. Thirteen patients were withdrawn for other reasons: The reasons for corticosteroid treatment were brain herniation in three patientspulmonary problems in threedisseminated intravascular coagulation in oneand acute disseminated encephalomyelitis in one.

Cranial computed tomography CT showed diffuse brain swelling in the patients with herniation and hypodense lesions in the patient with acute disseminated encephalomyelitis. Eight weeks after admission, neurologic examinations were performed in of patients 97 percent. Seven patients were lost to follow-up, three in the dexamethasone group and four in the placebo group. At discharge, six of these seven patients had a score of 5 on the Glasgow Outcome Scale, and one had a score of 4, shin Schmerz Thrombophlebitis.

These last-observation scores were carried forward to eight weeks, so that all patients were included in the analyses of the primary outcome and mortality.

Classic symptoms and signs of meningitis were present in a large proportion of the patients headache in 94 percent, fever in 81 percent, and neck stiffness in 94 percent. At base line, the clinical characteristics and the results of laboratory tests were similar in the dexamethasone and placebo groups, although a higher percentage of patients in the dexamethasone group had seizures Table 1 Table 1 Base-Line Characteristics of the Study Population.

The mean cerebrospinal fluid pressure was also similar in the two groups, as was the proportion of patients in the two groups shin Schmerz Thrombophlebitis had very high pressure 40 cm of water or higher, shin Schmerz Thrombophlebitis. Gram's staining of cerebrospinal fluid specimens, performed in patients, showed bacteria in patients 74 percent.

Cerebrospinal fluid culture yielded bacteria in of patients 78 percent. Forty-three of the 65 patients 66 percent with negative cerebrospinal fluid cultures had at least one individual cerebrospinal fluid finding that was predictive of bacterial meningitis a glucose level below 34 mg per deciliter [1.

Eight weeks after enrollment, the percentage of patients with an unfavorable outcome was significantly smaller in the dexamethasone group than in the placebo group 15 percent vs. The benefit of dexamethasone remained substantial in an analysis adjusted for other risk factors adjusted odds ratio, 0. Among the patients with pneumococcal meningitis, 26 percent in the dexamethasone group had an unfavorable outcome, as compared with 52 percent in the placebo group.

Among the patients with meningitis due to N. The proportion of patients who died was significantly smaller in the dexamethasone group than in the placebo group 7 percent vs. Among the patients with pneumococcal meningitis, 14 percent of those who received dexamethasone and 34 percent of those who received placebo died. Adjuvant treatment with dexamethasone did not have a significant beneficial effect on neurologic sequelae, including hearing loss. During admission, audiologic examination was performed in 28 patients, 14 of whom had severe hearing loss 60 dB or more in one or both ears.

At eight weeks, 27 patients had hearing loss. The lower mortality in the dexamethasone group did not result in an increased rate of severe neurologic sequelae in this group. Dexamethasone appeared to be most beneficial in patients with shin Schmerz Thrombophlebitis or severe disease. Adverse events resulted in the early withdrawal of four patients in the dexamethasone group and one in the placebo group Figure 1.

In the dexamethasone group, two patients were withdrawn because of severe hyperglycemia, one because of suspected stomach perforation which was not the caseand one because of agitation and flushing.


Original Article. Dexamethasone in Adults with Bacterial Meningitis. Jan de Gans, Ph.D., and Diederik van de Beek, M.D., for the European Dexamethasone in Adulthood.

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Original Article. Dexamethasone in Adults with Bacterial Meningitis. Jan de Gans, Ph.D., and Diederik van de Beek, M.D., for the European Dexamethasone in Adulthood.
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Original Article. Dexamethasone in Adults with Bacterial Meningitis. Jan de Gans, Ph.D., and Diederik van de Beek, M.D., for the European Dexamethasone in Adulthood.
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Original Article. Dexamethasone in Adults with Bacterial Meningitis. Jan de Gans, Ph.D., and Diederik van de Beek, M.D., for the European Dexamethasone in Adulthood.
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Original Article. Dexamethasone in Adults with Bacterial Meningitis. Jan de Gans, Ph.D., and Diederik van de Beek, M.D., for the European Dexamethasone in Adulthood.
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