Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2)

BACKGROUND: Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation (IMV) and the most commonly prescribed treatment in intensive care units (ICUs). International guidelines consistently indicate that enteral nutrition (EN) should be preferred over parenteral nutrition (PN) whenever possible and started as early as possible. However, no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality. The primary goal of this trial is to assess the hypothesis that early first-line EN, as compared to early first-line PN, decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock. METHODS/DESIGN: The NUTRIREA-2 study is a multicenter, open-label, parallel-group, randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48 hours, combined with vasoactive drugs, for shock. Patients will be allocated at random to first-line PN for at least 72 hours or to first-line EN. In both groups, nutritional support will be started within 24 hours after IMV initiation. Calorie targets will be 20 to 25 kcal/kg/day during the first week, then 25 to 30 kcal/kg/day thereafter. Patients receiving PN may be switched to EN after at least 72 hours in the event of shock resolution (no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2 mmol/L). On day 7, all patients receiving PN and having no contraindications to EN will be switched to EN. In both groups, supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake. We plan to recruit 2,854 patients at 44 participating ICUs. DISCUSSION: The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients. Enrollment started on 22 March 2013 and is expected to end in November 2015. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01802099 (registered 27 February 2013)

Posologie de la ceftazidime chez le grand brûlé (recommandations basées sur une étude de cinétique de population)

TOULOUSE3-BU Santé-Centrale (315552105) / SudocSudocFranceF

Incidence of, risk factors for and impact of readmission for heart failure after successful transcatheter aortic valve implantation

International audienceBackground: The incidence of and risk factors for readmission for heart failure after successful transcatheter aortic valve implantation (TAVI) are unclear.Aims: We sought to evaluate the incidence of, risk factors for and clinical impact of readmission for heart failure after successful TAVI in an unselected patient population.Methods: All patients who underwent successful TAVI in two high-volume French tertiary centres from February 2010 to December 2016 were included prospectively and followed up for 1 year. A Cox multivariable model was used to assess risk factors for readmission for heart failure and mortality.Results: A total of 1139 patients (mean age 82.4±7.7years; 52.2% male sex) were included. Readmission for heart failure occurred in 99 (9.2%) patients. Risk factors for readmission for heart failure were previous atrial fibrillation (adjusted hazard ratio [adjHR] 1.62, 95% confidence interval [CI] 1.09-2.40), diabetes mellitus (adjHR 1.67, 95% CI 1.11-2.50), chronic kidney disease (adjHR 1.72, 95% CI 1.13-2.62), chronic pulmonary disease (adjHR 1.81, 95% CI 1.17-2.81) and left ventricular ejection fraction after TAVI ≤ 35% (adjHR 2.12, 95% CI 1.20-3.75). Readmission for heart failure was strongly associated with mortality (adjHR 3.11, 95% CI 1.95-4.94), along with increased Society of Thoracic Surgeons' score (adjHR 1.07, 95% CI 1.03-1.12), chronic pulmonary disease (adjHR 1.45, 95% CI 1.00-2.09), previous atrial fibrillation (adjHR 2.11, 95% CI 1.52-2.93) and shock during the index hospitalization (adjHR 2.56, 95% CI 1.41-4.65).Conclusions: Readmission for heart failure occurs in one in 10 patients after successful TAVI, and is a strong risk factor for mortality. Co-morbidities and left ventricular ejection fraction after TAVI≤35% are the main risk factors for readmission for heart failure

Carotid versus femoral access for transcatheter aortic valve replacement: comparable results in the current era

International audienceAbstract OBJECTIVES The carotid approach for transcatheter aortic valve replacement (TAVR) has been shown to be feasible and safe. The goal of this study was to compare the 30-day outcomes of trans-carotid (TC) and transfemoral (TF) TAVR. METHODS This retrospective study enrolled 500 consecutive patients treated by TC-TAVR (n = 100) or TF-TAVR (n = 400) with percutaneous closure between January 2018 and January 2020 at the Nantes University Hospital. The primary end-point was the occurrence of cardiovascular death and cerebrovascular events at 30 days. RESULTS The mean age was 79.9 ± 8.1 in the TC group and 81.3 ± 6.9 (P = 0.069) in the TF group. The TC group had more men (69% vs 50.5%; P = 0.001) and more patients with peripheral vascular disease (86% vs 14.8%; P < 0.0001). Cardiac characteristics were similar between the groups, and the EuroSCORE II was 3.8 ± 2.6% vs 4.6 ± 6.0%, respectively (P = 0.443). The 30-day mortality was 2% in the TC group versus 1% in the TF group (P = 0.345). TC-TAVR was not associated with an increased risk of stroke (2% vs 2.5%; P = 0.999) or major vascular complications (2% vs 4%; P = 0.548). More permanent pacemakers were implanted in the TF group (14.9% vs 5.6%; P = 0.015), and no moderate or severe aortic regurgitation was observed in the TC group (0 vs 3.3%; P = 0.08). TC-TAVR was not associated with an increased risk of mortality or stroke at 30 days (odds ratio 1.32; 95% confidence interval 0.42–4.21; P = 0.63) in the multivariable analysis. CONCLUSIONS No statistically significant differences between TC-TAVR and TF-TAVR were observed; therefore, TC-TAVR should be the first alternative in patients with anatomical contraindications to the femoral route

Impact du traitement anticoagulant oral dans le devenir clinique et l’évolution des paramètres hémodynamique après un remplacement valvulaire aortique percutanée

International audienceBackgroundThe effect of oral anticoagulation on clinical and haemodynamic outcomes following successful transcatheter aortic valve implantation is unclear.AimsTo evaluate the effect of oral anticoagulation within the first year after transcatheter aortic valve implantation.MethodsAll patients undergoing transcatheter aortic valve implantation in two French tertiary centres from 2010 to 2016 were included prospectively. The composite outcome of death, stroke, readmission for heart failure or major/life-threatening bleeding according to Valve Academic Research Consortium 2 criteria within 1 year was evaluated. Valvular haemodynamic deterioration was defined as mean transprosthetic gradient ≥ 20 mmHg or an increase of ≥ 10 mmHg during echocardiographic follow-up.ResultsOf the 1139 patients included, 400 (35.1%) were discharged on oral anticoagulation. The primary endpoint was more frequent in the group with versus without oral anticoagulation (29.4% vs. 17.3% 21.5%; hazard ratio 1.83, 95% confidence interval 1.42–2.35). Composite endpoint risk factors were chronic pulmonary and kidney diseases, previous atrial fibrillation, left ventricular ejection fraction ≤ 30% at discharge and no femoral vascular approach, but not oral anticoagulation prescription at discharge. Conversely, 58 patients were identified with valvular haemodynamic deterioration, including 11 (19%) in the group with oral anticoagulation and 47 (81%) in the group without oral anticoagulation. Valvular haemodynamic deterioration risk factors were absence of oral anticoagulation exposure, increased body mass index, use of a balloon-expandable bioprosthesis and use of a bioprosthesis with diameter ≤ 23 mm. Antithrombotic treatment crossover (i.e. oral anticoagulation interruption or introduction during follow-up) occurred in 9.6% of patients, and was a risk factor for death (adjusted hazard ratio 3.39, 95% confidence interval 1.63–7.07).ConclusionsBaseline characteristics, rather than oral anticoagulation prescription at discharge, were associated with adverse outcomes following successful transcatheter aortic valve implantation. Conversely, oral anticoagulation was associated with reduced valvular haemodynamic deterioration.ContexteL’impact du traitement anticoagulant oral (TAO) sur les paramètres cliniques et hémodynamiques après TAVI demeure incertain.ObjectifsÉvaluer l’impact du TAO dans l’année suivant un TAVI.MéthodesTous les patients traités par TAVI dans deux centres français entre 2010 et 2016 furent prospectivement inclus. Le critère de jugement principal (CJP) était composé de la mortalité, accident vasculaire cérébrale, hospitalisation pour insuffisance cardiaque ou hémorragie sévères, défini selon les critères VARC-2. Une détérioration hémodynamique valvulaire prothétique (DHV) était définie par un gradient moyen transprothétique ≥ 20 mmHg ou par une majoration ≥ 10 mmHg durant le suivi échocardiographique.RésultatsUn TAO fut prescrit à 400 patients soit 35,1 % des 1139 patients inclus dans le registre. Le CJP est survenu plus fréquemment en cas de TAO post-TAVI qu’en son absence (29,4 % vs 17,3 % %; HR 1,83, IC à 95 % 1,42–2,35). Les facteurs de risque (FdR) du CJP étaient une pneumopathie chronique, une insuffisance rénale chronique, une fibrillation atriale, une FEVG ≤ 30 % après TAVI et un abord vasculaire extrafémoral. La prescription de TAO après un TAVI n’était pas un FdR indépendant du CJP. Une DHV fut relevée chez 58 patients, dont 11 (19 %) traités par TAO et 47 (81 %) non traités par TAO. Les FdR de DHV étaient l’absence de TAO après TAVI, un IMC augmenté, l’utilisation de bioprothèse expansible au ballon et un diamètre de bioprothèse ≤ 23 mm. Un crossover de TAO (défini comme un arrêt ou une initiation de TAO au cours du suivi) survenu chez 9,6 % des patients et était associé à la mortalité (HR ajusté 3,39, IC à 95 % 1,63–7,07).ConclusionsLes antécédents médicaux et non la prescription de TAO sont associés au devenir clinique après un TAVI. A l’inverse, la prescription de TAO est associée à une moindre survenue de DHV. Previous article in issu

Concomitant cases of disseminated Geotrichum clavatum infections in patients with acute myeloid leukemia

International audienc

Indications actuelles de la contre-pulsion par ballonnet intra-aortique : le registre CP-GARO

International audienceBACKGROUND: Intra-aortic balloon pumps (IABPs) have been used routinely since the 1970s. Recently, large randomized trials failed to show that IABP therapy has meaningful benefit, and international recommendations downgraded its place, particularly in cardiogenic shock. AIMS: The aim of this registry was to describe the contemporary use of IABP therapy, in light of these new data. METHODS: This prospective multicentre registry included 172 patients implanted with an IABP in 19 French cardiac centres in 2015. Baseline characteristics, aetiologies leading to IABP use, and IABP-related and disease-related complications were assessed. In-hospital and 1-year mortality rates were studied. RESULTS: A total of 172 patients were included (mean age 65.5±12.0 years; 118 men [68.6%]). The reasons for IABP implantation were mainly haemodynamic (n=107; 62.2%), followed by bridge to revascularization (n=34; 19.8%) and four other "rare" aetiologies (n=29 patients; 16.8%). In-hospital and 1-year mortality rates were 40.7% and 45.8%, respectively. Fourteen patients (8.1%) experienced ischaemic or haemorrhagic complications, which were directly related to the IABP in seven patients (4.1%). CONCLUSIONS: Despite current international guidelines regarding the place of IABPs in ischaemic cardiogenic shock without mechanical complications, this aetiology remains the leading cause for its utilization in the contemporary era

Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3)

Introduction International guidelines include early nutritional support (≤48 hour after admission), 20–25 kcal/kg/day, and 1.2–2 g/kg/day protein at the acute phase of critical illness. Recent data challenge the appropriateness of providing standard amounts of calories and protein during acute critical illness. Restricting calorie and protein intakes seemed beneficial, suggesting a role for metabolic pathways such as autophagy, a potential key mechanism in safeguarding cellular integrity, notably in the muscle, during critical illness. However, the optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding. We hypothesised that nutritional support with calorie and protein restriction during acute critical illness decreased day 90 mortality and/or dependency on intensive care unit (ICU) management in mechanically ventilated patients receiving vasoactive amine therapy for shock, compared with standard calorie and protein targets.Methods and analysis NUTRIREA-3 is a randomised, controlled, multicentre, open-label trial comparing two parallel groups of patients receiving invasive mechanical ventilation and vasoactive amine therapy for shock and given early nutritional support according to one of two strategies: early calorie-protein restriction (6 kcal/kg/day-0.2–0.4 g/kg/day) or standard calorie-protein targets (25 kcal/kg/day, 1.0–1.3 g/kg/day) at the acute phase defined as the first 7 days in the ICU. We will include 3044 patients in 61 French ICUs. Two primary end-points will be evaluated: day 90 mortality and time to ICU discharge readiness. The trial will be considered positive if significant between-group differences are found for one or both alternative primary endpoints. Secondary outcomes include hospital-acquired infections and nutritional, clinical and functional outcomes.Ethics and dissemination The NUTRIREA-3 study has been approved by the appropriate ethics committee. Patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.Trial registration number NCT03573739