on behalf of the CLASS-I/H/T InvestigatorsBackground and Purpose-A previous trial (the Clomethiazole Acute Stroke Study) generated the hypothesis that clomethiazole is effective in patients with a major ischemic stroke (total anterior circulation syndrome), and this was tested in the present study. Methods-A total of 1198 patients with major ischemic stroke and a combination of limb weakness, higher cortical dysfunction, and visual field deficits were randomly assigned to clomethiazole (68 mg/kg IV over 24 hours) or placebo. The study drug was initiated within 12 hours of symptom onset. Functional outcome and neurological recovery were assessed at days 7, 30, and 90, with the proportion of patients with a Barthel Index Ն60 at last follow-up as the primary outcome measure. Results-The patients were randomly assigned equally, and the two treatment groups were well matched for baseline characteristics, including stroke severity (mean National Institutes of Health Stroke Scale score 16.9Ϯ5.2). Ninety-six percent were classified as total anterior circulation syndrome. The proportion of patients reaching a Barthel Index score of Ն60 was 42% in the clomethiazole-treated group and 46% in the placebo-treated group (odds ratio, 0.81; 95% CI, 0.62 to 1.05; Pϭ0.11). There was no evidence of efficacy on any secondary outcome variables (modified Rankin Score, National Institutes of Health Stroke Scale, Scandinavian Stroke Scale, and 30-day CT infarct volumes) compared with placebo. Subgroup analysis showed a similar lack of treatment effect in patients treated early (Ͻ6 hours) and in those treated later (6 to 12 hours). Somnolence was an expected pharmacological effect of clomethiazole, and this occurred during treatment as an adverse event in half of the patients randomly assigned to study drug. Conclusions-The target population was selected, and sufficient drug was given to produce the expected pharmacological effect in the brain. Clomethiazole does not improve outcome in patients with major ischemic stroke.
Background: Myocardial dysfunction is one of the most important features of sepsis. The presence of cardiac dysfunction in sepsis has been associated with high mortality rate in septic patients. Material & Methods: This was prospective, observational cohort (patient with severe sepsis and septic shock) study conducted over period of one year in medical intensive care unit. Patients with an initial diagnosis of severe sepsis or septic shock were enrolled. Aims & Objectives:To study demographic profile, APACHE-II score and echocardiographic parameters in patients with severe sepsis and septic shock and to find out relation of echocardiographic parameters to variables of sepsis and outcome. Study Population: All patients underwent laboratory investigations, APACHE-II score and Transthoracic 2-Dimensional echocardiogram. Statistical analysis: Data was analysed by trial version SPSS-16 for mean, SD, chi-square test with'p' <0.05 was considered as statistically significant. Results: Of total 51 patients with sepsis and septic shock 32 were males and 19 were females with mean age of 51.48 (±13.11) years and 59.66 (±16.93) respectively. The mean LVEF was 35.70% (±7.47608). APACHE-II score had negative correlation with LVEF and positive with DD. Total 17.64% had normal LV diastolic function, 47.05% had grade-I diastolic dysfunction and 35.29% had grade-II diastolic dysfunction ['p'=0.082]. Overall mortality was 29.41% in patient with sepsis. Overall diastolic dysfunction was significantly more in patients with death compared to survived population ['p'= 0.0218 and 0.0329]. Conclusion: Diastolic dysfunction was common and a major predictor of mortality and outcome in severe sepsis and septic shock and was well correlated with APACHE-II score. Present study favors to use echocardiography as an ideal monitoring, tool in the septic patient for goal-oriented therapy for better outcome.
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