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Papazian L.,Assistance Publique Hopitaux de Marseille | Roch A.,Assistance Publique Hopitaux de Marseille | Charles P.-E.,CHU de Dijon | Penot-Ragon C.,Assistance Publique Hopitaux de Marseille | And 16 more authors.
JAMA - Journal of the American Medical Association | Year: 2013

IMPORTANCE: Observational studies have reported that statin use may be associated with improved outcomes of various infections. Ventilator-associated pneumonia (VAP) is the most common infection in the intensive care unit (ICU) and is associated with substantial mortality. OBJECTIVE: To determine whether statin therapy can decrease day-28 mortality in patients with VAP. DESIGN, SETTING, AND PARTICIPANTS: Randomized, placebo-controlled, double-blind, parallelgroup, multicenter trial performed in 26 intensive care units in France from January 2010to March 2013. For power to detect an 8%absolute reduction in the day-28 mortality rate,we planned to enroll 1002 patients requiring invasive mechanical ventilation for more than 2 days and having suspected VAP, defined as a modified Clinical Pulmonary Infection Score of 5 or greater. The futility stopping ruleswere an absolute increase in day-28 mortality of at least 2.7% with simvastatin compared with placebo after enrollment of the first 251 patients. INTERVENTIONS: Participants were randomized to receive simvastatin (60mg) or placebo, started on the same day as antibiotic therapy and given until ICU discharge, death, or day 28, whichever occurred first. MAIN OUTCOMES AND MEASURES: Primary outcomewas day-28 mortality. Day-14, ICU, and hospital mortality rates were determined, as well as duration of mechanical ventilation and Sequential Organ Failure Assessment (SOFA) scores on days 3, 7, and 14. RESULTS: The study was stopped for futility at the first scheduled interim analysis after enrollment of 300 patients, of whom all but 7% in the simvastatin group and 11% in the placebo group were naive to statin therapy at ICU admission. Day-28 mortality was not lower in the simvastatin group (21.2% [95% CI, 15.4% to 28.6%) than in the placebo group (15.2% [95% CI, 10.2% to 22.1%]; P = .10; hazard ratio, 1.45 [95% CI, 0.83 to 2.51]); the between-group difference was 6.0% (95% CI, -3.0% to 14.9%). In statin-naive patients, day-28 mortality was 21.5% (95% CI, 15.4% to 29.1%) with simvastatin and 13.8% (95% CI, 8.8% to 21.0%) with placebo (P = .054) (between-group difference, 7.7% [95% CI, -1.8% to 16.8%). There were no significant differences regarding day-14, ICU, or hospital mortality rates; duration of mechanical ventilation; or changes in SOFA score. CONCLUSIONS AND RELEVANCE: In adults with suspected VAP, adjunctive simvastatin therapy compared with placebo did not improve day-28 survival. These findings do not support the use of statins with the goal of improving VAP outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01057758.

Delarue R.,Service dHematologie Adultes | Tilly H.,University of Rouen | Mounier N.,Nice University Hospital Center | Petrella T.,CHU de Dijon | And 20 more authors.
The Lancet Oncology | Year: 2013

Background: Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has become the standard of care for elderly patients with diffuse large B-cell lymphoma. We aimed to ascertain if a dose-dense R-CHOP regimen administered every 2 weeks (R-CHOP14) was superior to the standard 3-week schedule (R-CHOP21). Methods: We did a randomised phase 3 trial at 83 centres in four countries. 602 patients aged 60-80 years with untreated diffuse large B-cell lymphoma and at least one adverse prognostic factor (age-adjusted international prognostic index ≥1) were eligible for the study. We randomly allocated individuals to R-CHOP-ie, rituximab (375 mg/m2), cyclophosphamide (750 mg/m2), doxorubicin (50 mg/m2), vincristine (1·4 mg/m2, up to 2 mg) all on day 1, and prednisone 40 mg/m2 daily for 5 days-administered every 14 days (n=304) or every 21 days (n=298) for eight cycles. We did permuted-block randomisation (block size four, allocation ratio 1:1) stratified by centre and number of adverse prognostic factors. The primary endpoint was event-free survival. Our analysis was of the intention-to-treat population, and we present the final analysis. This study is registered with ClinicalTrials.gov, number NCT00144755. Findings: Two patients allocated R-CHOP21 were ineligible for the study and were excluded from analyses. After median follow-up of 56 months (IQR 27-60), 3-year event-free survival was 56% (95% CI 50-62) in the R-CHOP14 group and 60% (55-66) in the R-CHOP21 group (hazard ratio 1·04, 95% CI 0·82-1·31; p=0·7614). Grade 3-4 neutropenia occurred in 224 (74%) of 304 patients allocated R-CHOP14 and 189 (64%) of 296 assigned R-CHOP21, despite increased use of granulocyte colony-stimulating factor in the R-CHOP14 group compared with the R-CHOP21 group. 143 (47%) patients in the R-CHOP14 group received at least one red-blood-cell transfusion versus 93 (31%) in the R-CHOP21 group (p=0·0001). 35 (12%) patients allocated R-CHOP14 received at least one platelet transfusion versus 25 (8%) assigned R-CHOP21 (p=0·2156). 155 (51%) patients who were assigned R-CHOP14 had at least one serious adverse event compared with 140 (47%) who were allocated R-CHOP21. Interpretation: In elderly patients with untreated diffuse large B-cell lymphoma and at least one adverse prognostic factor, a 2-week dose-dense R-CHOP regimen did not improve efficacy compared with the 3-week standard schedule. The frequency of toxic side-effects was similar between regimens, but R-CHOP14 was associated with increased need for red-blood-cell transfusion. Funding: Groupe d'Etude des Lymphomes de l'Adulte (GELA), Amgen. © 2013 Elsevier Ltd.

Gouyon J.-B.,CHU de Dijon | Gouyon J.-B.,University of Burgundy | Vintejoux A.,CHU de Dijon | Sagot P.,University of Burgundy | And 6 more authors.
International Journal of Epidemiology | Year: 2010

Background Approximately 75% of preterm births are late-preterm (340/7 to 366/7 weeks gestation). This group has usually been considered as a whole in studies assessing the outcome of these preterm infants by comparison with term infants. However, the respective contribution to prognosis of each week of gestation has not been fully clarified. Methods A population-based study of 150 426 live-born singleton neonates with gestational ages ranging from 34 to 41 weeks of gestation. Results The rate of severe respiratory disorders (treated by mechanical ventilation and/or nasal continuous positive airway pressure) markedly declined with gestational age from 19.8% at 34 weeks to 0.28% at 39-41 weeks. Between 34 and 38 weeks, each additional week diminished the relative risk (crude or adjusted) of severe respiratory disorders by a factor varying from 2 to 3. The rate of poor prognosis (death and/or severe neurological condition) significantly declined between 34 and 38 weeks and remained stable thereafter. A multivariate analysis showed that antepartum haemorrhage and hypertensive disorders during pregnancy were significantly associated with severe respiratory disorders and poor outcome. Diabetes was an additional factor associated with severe respiratory disorders. Conclusions Future studies should delineate more precisely the respective contribution of gestational age, maternal complication and induced delivery in the prognosis of infants born between 33 and 39 weeks gestation. © The Author 2010. Published by Oxford University Press on behalf of the International Epidemiological Association. All rights reserved.

University of Burgundy and Chu De Dijon | Date: 2013-07-05

The present invention relates to a pharmaceutical composition including Lipiodol and a molecule with anti-tumour activity and secondarily a hydroxyethyl starch. The present invention also relates to the use of the compositions according to the invention for treating cancer. According to one embodiment, the pharmaceutical composition according to the invention has between 0.004% and 0.2% by weight of idarubicin, between 0.38% and 2.25% by weight of hydroxyethyl starch and secondarily between 60% and 68% by weight of Lipiodol, and water for injection (or even physiological saline) in a quantity sufficient (q.s.) for 100%.

Fortinsky K.J.,University of Toronto | Bardou M.,CHU de Dijon | Barkun A.N.,McGill University
Gastrointestinal Endoscopy Clinics of North America | Year: 2015

Nonvariceal upper gastrointestinal bleeding (UGIB) is a major cause of morbidity and mortality worldwide. Mortality from UGIB has remained 5-10% over the past decade. This article presents current evidence-based recommendations for the medical management of UGIB. Preendoscopic management includes initial resuscitation, risk stratification, appropriate use of blood products, and consideration of nasogastric tube insertion, erythromycin, and proton pump inhibitor therapy. The use of postendoscopic intravenous proton pump inhibitors is strongly recommended for certain patient populations. Postendoscopic management also includes the diagnosis and treatment of Helicobacter pylori, appropriate use of proton pump inhibitors and iron replacement therapy. © 2015 Elsevier Inc.

Bardou M.,CHU de Dijon | Quenot J.-P.,Medical Intensive Care Unit | Barkun A.,McGill University
Nature Reviews Gastroenterology and Hepatology | Year: 2015

Bleeding from stress-related mucosal disease in critically ill patients remains an important clinical management issue. Although only a small proportion (1-6%) of patients admitted to an intensive care unit (ICU) will bleed, a substantial proportion exhibit clinical risk factors (mechanical ventilation for >48 h and a coagulopathy) that predict an increased risk of bleeding. Furthermore, upper gastrointestinal mucosal lesions can be found in 75-100% of patients in ICUs. Although uncommon, stress-ulcer bleeding is a severe complication with an estimated mortality of 40-50%, mostly from decompensating an underlying condition or multiorgan failure. Although the vast majority of patients in ICUs receive stress-ulcer prophylaxis, largely with PPIs, some controversy surrounds their efficacy and safety. Indeed, no single trial has shown that stress-ulcer prophylaxis reduces mortality. Some reports suggest that the use of PPIs increases the risk of nosocomial infections. However, several meta-analyses and cost-effectiveness studies suggest PPIs to be more clinically effective and cost-effective than histamine-2 receptor antagonists, without considerable increases in nosocomial pneumonia. To help clinicians use the most appropriate strategy for treatment of patients in the ICU, this Review presents the latest information on all aspects of stress-related mucosal disease. © 2015 Macmillan Publishers Limited. All rights reserved.

Chavanet P.,CHU de Dijon
Medecine et Maladies Infectieuses | Year: 2013

Background: Methicillin-resistant Staphylococcus aureus (MRSA) accounts for 10-40% of hospital-acquired pneumonia, and even more in intensive care units. The current guidelines for the treatment of MRSA nosocomial pneumonia include vancomycin and linezolid. The authors of 2 prospective randomized trials comparing vancomycin and linezolid in nosocomial pneumonia had concluded to the non-inferiority of linezolid. A slight superiority of linezolid was observed in the MRSA pneumonia subgroup, in terms of clinical success and survival, but no definite conclusion could be drawn. Methods: A prospective randomized study was made to compare a fixed linezolid dose to dose-optimized vancomycin for the treatment of bacteriologically proven MRSA nosocomial pneumonia (ZEPHyR Study). Results: Among the 165 patients treated by linezolid (57.6%) in the PP population, 95 were clinically cured at the end of the study, compared to 81 of the 174 patients treated by vancomycin (46.6%) (IC 95% of the difference 0.5%-21.6%, P= 0.042). Nephrotoxicity in the mITT population reached 8.4% in the linezolid group compared to 18.2% in the vancomycin group. Conclusion: LNZ was superior to vancomycin for the treatment of MRSA nosocomial pneumonia. © 2013 Elsevier Masson SAS.

Aim. The main objective of the study was to describe changes in the blood pressure (BP) values of a cohort of elderly subjects as a result of substituting NaCl with NaCl+Chitosan 3% (Symbiosal®) in their diet (salt used during food preparation and added table salt). Methods. An observational study was conducted in a rehabilitation centre for elderly where all cooked foods are produced by the local kitchen and all the salt NaCl traditionally used was replaced by Symbiosal®. All patients, hypertensive or not, were followed at inclusion and then every month to monitor their BP parameters over three months. Results. In the total population of seventy-seven patients, SBP (mmHg) decreases from 130±17 at inclusion to 123±10 at 3 months (-7.8±8.5) (P<0.0001). In sixteen persons, whose hypertension was not under control at inclusion, it decreases from 156±18 to 136±12 after 3 months (-19.6±7.3) (P<0.0001) and among them 68.5% were controlled. In the subject with limit hypertension (between 130-140) it decreases from 135.7±3.1 to 123.2±4.9 (-12.5±4.6) (P<0.0001). Conclusion. NaCl + chitosan 3% seems to reduce significantly the BP. This suggests that it could be used either in the field of a low salt diet in hypertensive patients but also in general or elderly population in addition to the recommendation of a salt reduction.

Two thirds of the patients hospitalized for an acute coronary syndrome (ACS) show disorders of glucose metabolism (diabetes, impaired fasting glucose, impaired glucose intolerance).Every patient hospitalized for an ACS whose HbA1c is equal or above 6.5% must be considered as diabetic.Each patient hospitalized for an ACS whose HbA1c is less than 6.5% should have measurement of plasma glucose fasting and after an oral glucose load between the 7th and the 28th day following the ACS in order to detect a disorder of glucose metabolism.During the hospitalization in cardiac intensive care unit, a treatment with insulin will be started when plasma glucose is. ≥. 1.80. g/L (10.0. mmol/L). In a patient with previously known diabetes, a treatment with insulin will also be started when preprandial plasma glucose is 1.40. g/L (7.8. mmol/L).Insulin treatment in cardiac intensive care unit will be performed by continuous IV infusion of insulin including bolus for meals. Insulin dosage will be determined according to the capillary glucose monitoring.After the hospitalization in cardiac intensive care unit, it is often possible to stop insulin treatment, which may be replaced by other antidiabetic treatments.The choice of the optimal antidiabetic treatment depends on the metabolic profile of the patient (insulin-resistance, insulin deficiency). This choice is not always easy and referral to an endocrinologist/diabetolgist may be needed.Because of the increased cardiovascular mortality associated with hypoglycemias, the long-term use of insulin or insulin-secretory agents (sulfonylureas, glinides) must be limited.During and in the immediate follow-up of an ACS, referral to an endocrinologist/diabetologist is recommended in case of diagnosis of diabetes, when HbA1c. ≥. 8%, when long-term treatment with insulin has been initiated and in case of frequent or severe hypoglycemias. © 2016 Elsevier Masson SAS.

Chu De Dijon | Date: 2014-01-31

The invention relates to a method for detecting a colorectal lesion likely to evolve into invasive colorectal cancer, in a patient, by determining the presence of Liver Fatty Acid-Binding Protein (LFABP), in a biological sample of the patient, distant form the lesion.

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