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1.
Crit Care ; 28(1): 43, 2024 02 07.
Article in English | MEDLINE | ID: mdl-38326920

ABSTRACT

BACKGROUND: Albumin has potential endothelial protective effects through antioxidant and anti-inflammatory properties. However, the effect of albumin on peripheral tissue perfusion in human sepsis remains poorly known. METHODS: Bi-centric prospective study included patients with sepsis with or without shock and prolonged CRT > 3 s despite initial resuscitation. Clinicians in charge of the patients were free to infuse either saline 500 mL or human serum albumin 20% 100 mL over 15 min. Global hemodynamic parameters as well as peripheral tissue perfusion were analyzed after 1 (H1) and 4 h (H4). The primary endpoint was CRT normalization (< 3 s) at H1. RESULTS: 62 patients were screened, and 50 patients (13 sepsis and 37 septic shock) were included, 21 in the saline group and 29 in the albumin group. SOFA score was 8 [5-11], and SAPS II was 53 [45-70]. Median age was 68 [60-76] years with a higher proportion of men (74%). The primary sources of infection were respiratory (54%) and abdominal (24%). At baseline, comorbidities, clinical and biological characteristics were similar between groups. At H1, CRT normalization (< 3 s) was more frequent in patients receiving albumin as compared to patients treated by saline (63 vs 29%, P = 0.02). The decrease in fingertip CRT was more important in the albumin group when compared to saline group (- 1.0 [- 0.3; - 1.5] vs - 0.2 [- 0.1; - 1.1] seconds, P = 0.04) as well as decrease in mottling score. At H4, beneficial effects of albumin on peripheral tissue perfusion were maintained and urinary output trended to be higher in the albumin group (1.1 [0.5-1.8] vs 0.7 [0.5-0.9] ml/kg/h, P = 0.08). Finally, arterial lactate level did not significantly change between H0 and H4 in the saline group but significantly decreased in the albumin group (P = 0.03). CONCLUSION: In patients with resuscitated sepsis, albumin infusion might lead to greater improvement of tissue hypoperfusion compared to saline. CLINICALTRIALS: gov Identifier: NCT05094856.


Subject(s)
Sepsis , Shock, Septic , Humans , Male , Aged , Prospective Studies , Sepsis/complications , Sepsis/therapy , Shock, Septic/complications , Shock, Septic/drug therapy , Resuscitation , Saline Solution , Albumins/therapeutic use , Ischemia
2.
PLoS Med ; 20(12): e1004317, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38060611

ABSTRACT

BACKGROUND: Asymptomatic and paucisymptomatic infections account for a substantial portion of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) transmissions. The value of intensified screening strategies, especially in emergency departments (EDs), in reaching asymptomatic and paucisymptomatic patients and helping to improve detection and reduce transmission has not been documented. The objective of this study was to evaluate in EDs whether an intensified SARS-CoV-2 screening strategy combining nurse-driven screening for asymptomatic/paucisymptomatic patients with routine practice (intervention) could contribute to higher detection of SARS-CoV-2 infections compared to routine practice alone, including screening for symptomatic or hospitalized patients (control). METHODS AND FINDINGS: We conducted a cluster-randomized, two-period, crossover trial from February 2021 to May 2021 in 18 EDs in the Paris metropolitan area, France. All adults visiting the EDs were eligible. At the start of the first period, 18 EDs were randomized to the intervention or control strategy by balanced block randomization with stratification, with the alternative condition being applied in the second period. During the control period, routine screening for SARS-CoV-2 included screening for symptomatic or hospitalized patients. During the intervention period, in addition to routine screening practice, a questionnaire about risk exposure and symptoms and a SARS-CoV-2 screening test were offered by nurses to all remaining asymptomatic/paucisymptomatic patients. The primary outcome was the proportion of newly diagnosed SARS-CoV-2-positive patients among all adults visiting the 18 EDs. Primary analysis was by intention-to-treat. The primary outcome was analyzed using a generalized linear mixed model (Poisson distribution) with the center and center by period as random effects and the strategy (intervention versus control) and period (modeled as a weekly categorical variable) as fixed effects with additional adjustment for community incidence. During the intervention and control periods, 69,248 patients and 69,104 patients, respectively, were included for a total of 138,352 patients. Patients had a median age of 45.0 years [31.0, 63.0], and women represented 45.7% of the patients. During the intervention period, 6,332 asymptomatic/paucisymptomatic patients completed the questionnaire; 4,283 were screened for SARS-CoV-2 by nurses, leading to 224 new SARS-CoV-2 diagnoses. A total of 1,859 patients versus 2,084 patients were newly diagnosed during the intervention and control periods, respectively (adjusted analysis: 26.7/1,000 versus 26.2/1,000, adjusted relative risk: 1.02 (95% confidence interval (CI) [0.94, 1.11]; p = 0.634)). The main limitation of this study is that it was conducted in a rapidly evolving epidemiological context. CONCLUSIONS: The results of this study showed that intensified screening for SARS-CoV-2 in EDs was unlikely to identify a higher proportion of newly diagnosed patients. TRIAL REGISTRATION: Trial registration number: ClinicalTrials.gov NCT04756609.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Female , Humans , Middle Aged , COVID-19/diagnosis , COVID-19/epidemiology , Cross-Over Studies , Emergency Service, Hospital , France/epidemiology , Paris/epidemiology , Surveys and Questionnaires , Male
3.
Am Heart J ; 266: 98-105, 2023 12.
Article in English | MEDLINE | ID: mdl-37716448

ABSTRACT

BACKGROUND: Anterior acute myocardial infarction (AMI) is associated with an increased risk of left ventricular (LV) thrombus formation. We hypothesized that adding low-dose oral rivaroxaban to the usual antiplatelet regimen would reduce the risk of LV thrombus in patients with large AMI. STUDY DESIGN: APERITIF is an investigator-initiated, multicenter randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing "FRENCHIE" registry, a French multicenter prospective observational study, in which all consecutive patients admitted within 48 hours of symptom onset in a cardiac Intensive Care Unit (ICU) for AMI are included (NCT04050956). Among them, patients with anterior ST-elevation-myocardial infarction (STEMI) or very high-risk non- ST-elevation-myocardial infarction (NSTEMI) patients with involvement of the left anterior descending artery are randomized into 2 groups: Dual Antiplatelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, started as soon as possible after completion of the initial percutaneous coronary intervention/angiography procedure. The primary endpoint is the presence of LV thrombus at 1 month, as detected by contrast enhanced CMR (CE-CMR). Secondary endpoints include LV thrombus dimension (greatest diameter), the rate of major bleedings and major cardiovascular events at 1 month. Based on estimated event rates, a sample size of 560 patients is needed to show superiority of DAPT plus rivaroxaban therapy versus DAPT alone, with 80% power. CONCLUSION: The APERITIF trial will determine whether, in patients with large AMIs, the use of rivaroxaban 2.5mg twice daily in addition to DAPT reduces LV thrombus formation, compared with DAPT alone. CLINICALTRIALS: gov Identifier: NCT05077683.


Subject(s)
Anterior Wall Myocardial Infarction , Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Thrombosis , Humans , Platelet Aggregation Inhibitors/therapeutic use , ST Elevation Myocardial Infarction/therapy , Rivaroxaban/therapeutic use , Treatment Outcome , Myocardial Infarction/diagnosis , Thrombosis/etiology , Thrombosis/prevention & control , Anticoagulants/therapeutic use , Percutaneous Coronary Intervention/adverse effects
4.
BMC Emerg Med ; 23(1): 140, 2023 Nov 29.
Article in English | MEDLINE | ID: mdl-38030975

ABSTRACT

BACKGROUND: The aim of this trial-based economic evaluation was to assess the incremental costs and cost-effectiveness of the modified diagnostic strategy combining the YEARS rule and age-adjusted D-dimer threshold compared with the control (which used the age-adjusted D-dimer threshold only) for the diagnosis of pulmonary embolism (PE) in the Emergency Department (ED). METHODS: Economic evaluation from a healthcare system perspective alongside a non-inferiority, crossover, and cluster-randomized trial conducted in 16 EDs in France and two in Spain with three months of follow-up. The primary endpoint was the additional cost of a patient without failure of the diagnostic strategy, defined as venous thromboembolism (VTE) diagnosis at 3months after exclusion of PE during the initial ED visit. Mean differences in 3-month failure and costs were estimated using separate generalized linear-regression mixed models, adjusted for strategy type, period, and the interaction between strategy and period as fixed effects and the hospital as a random effect. The incremental cost-effectiveness ratio (ICER) was obtained by dividing the incremental costs by the incremental frequency of VTE. RESULTS: Of the 1,414 included patients, 1,217 (86%) were analyzed in the per-protocol analysis (648 in the intervention group and 623 in the control group). At three months, there were no statistically significant differences in total costs (€-46; 95% CI: €-93 to €0.2), and the failure rate was non inferior in the intervention group (-0.64%, one-sided 97.5% CI: -∞ to 0.21%, non-inferiority margin 1.5%) between groups. The point estimate of the incremental cost-effectiveness ratio (ICER) indicating that each undetected VTE averted in the intervention group is associated with cost savings of €7,142 in comparison with the control group. There was a 93% probability that the intervention was dominant. Similar results were found in the as randomized population. CONCLUSIONS: Given the observed cost decrease of borderline significance, and according to the 95% confidence ellipses, the intervention strategy has a potential to lead to cost savings as a result of a reduction in the use of chest imaging and of the number of undetected VTE averted. Policy-makers should investigate how these monetary benefits can be distributed across stakeholders. CLINICALTRIALS: Trial registration number ClinicalTrials.gov Identifier: NCT04032769; July 25, 2019.


Subject(s)
Pulmonary Embolism , Venous Thromboembolism , Humans , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiology , Cost-Benefit Analysis , Pulmonary Embolism/diagnosis , Emergency Service, Hospital , France
5.
J Tissue Viability ; 32(1): 20-25, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36599729

ABSTRACT

AIMS: As a prerequisite of a multicentre study, we conducted a pilot study to assess the feasibility of a daily repositioning schedule in critically ill patients. The schedule was adapted to the patient's clinical condition, and the estimated risk for developing a pressure ulcer using the Braden scale. DESIGN: A single-center pre and post-intervention pilot study in a French Intensive Care Unit of a university teaching hospital. This study followed TREND guidelines. METHODS: During the first period (March to May 2018), pressure ulcer prevention was performed according to usual care. During the second period (June to August 2018), the repositioning schedule was adapted to the estimated risk for developing a pressure ulcer according to the Braden scale. Eligible patients had no pressure ulcer at baseline, were intubated within 24 hours of admission and expected to receive mechanical ventilation for at least 24 hours. The primary outcome was the rate of pressure ulcer development at 28 days of hospitalization or at discharge or death, as compared with usual care. Secondary outcomes included the feasibility and safety of the schedule, as assessed by caregivers' adherence and workload, and the rate of adverse events. RESULTS: In the pre-intervention period 20 participants were included, and 14 patients were included in the post-intervention period. There was no decrease in the pressure ulcers incidence with the intervention (25% vs. 28.6%; P = 1). The number of daily repositioning performed increased from 3.3 [IQR 3.0; 3.9] during the pre-intervention period to 4.3 [IQR 3.8; 5.2] during the post-intervention period (P < 0.05), where it differed from the number scheduled by 0.6 [IQR 0.1; 1.4] per day, indicating satisfactory adherence of caregivers to the protocol. Adverse events rate did not differ between the two periods (55.9% vs. 57.1%; P = 0.90). CONCLUSION: A personalised daily repositioning schedule in critically ill patients is feasible and safe. The efficacy of such a strategy, together with its economic impact, need to be assessed in a multicentre randomized trial.


Subject(s)
Pressure Ulcer , Ulcer , Humans , Pilot Projects , Critical Illness , Feasibility Studies , Intensive Care Units , Pressure Ulcer/prevention & control
6.
J Med Genet ; 57(3): 160-168, 2020 03.
Article in English | MEDLINE | ID: mdl-31586944

ABSTRACT

BACKGROUND: The type 1 insulin-like growth factor receptor (IGF1R) is a keystone of fetal growth regulation by mediating the effects of IGF-I and IGF-II. Recently, a cohort of patients carrying an IGF1R defect was described, from which a clinical score was established for diagnosis. We assessed this score in a large cohort of patients with identified IGF1R defects, as no external validation was available. Furthermore, we aimed to develop a functional test to allow the classification of variants of unknown significance (VUS) in vitro. METHODS: DNA was tested for either deletions or single nucleotide variant (SNV) and the phosphorylation of downstream pathways studied after stimulation with IGF-I by western blot analysis of fibroblast of nine patients. RESULTS: We detected 21 IGF1R defects in 35 patients, including 8 deletions and 10 heterozygous, 1 homozygous and 1 compound-heterozygous SNVs. The main clinical characteristics of these patients were being born small for gestational age (90.9%), short stature (88.2%) and microcephaly (74.1%). Feeding difficulties and varying degrees of developmental delay were highly prevalent (54.5%). There were no differences in phenotypes between patients with deletions and SNVs of IGF1R. Functional studies showed that the SNVs tested were associated with decreased AKT phosphorylation. CONCLUSION: We report eight new pathogenic variants of IGF1R and an original case with a homozygous SNV. We found the recently proposed clinical score to be accurate for the diagnosis of IGF1R defects with a sensitivity of 95.2%. We developed an efficient functional test to assess the pathogenicity of SNVs, which is useful, especially for VUS.


Subject(s)
Abnormalities, Multiple/genetics , Fetal Development/genetics , Fetal Growth Retardation/genetics , Growth Disorders/genetics , Receptor, IGF Type 1/genetics , Abnormalities, Multiple/epidemiology , Abnormalities, Multiple/physiopathology , Adolescent , Child , Dwarfism/genetics , Dwarfism/physiopathology , Female , Fetal Growth Retardation/epidemiology , Fetal Growth Retardation/physiopathology , Growth Disorders/epidemiology , Growth Disorders/physiopathology , Heterozygote , Homozygote , Humans , Infant, Small for Gestational Age/growth & development , Insulin-Like Growth Factor I/genetics , Insulin-Like Growth Factor II/genetics , Male , Microcephaly/genetics , Microcephaly/physiopathology , Mutation, Missense/genetics , Pedigree , Polymorphism, Single Nucleotide/genetics , Receptors, Somatomedin/genetics
7.
J Adv Nurs ; 77(6): 2875-2886, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33783846

ABSTRACT

BACKGROUND: Chronic non-cancer pain, which persists for at least three months, seriously affects quality of life. Chronic non-cancer pain patients are usually managed by a multidisciplinary team using pharmacological and non-pharmacological strategies. Nurses perform transcutaneous electrical nerve stimulation (TENS) and hypnosis, which are widely used in France for the treatment of chronic pain in pain departments. OBJECTIVE: To assess pain relief at three months, comparing a simultaneous combination of hypnosis and TENS (intervention) with TENS alone (control). DESIGN: Randomized controlled trial. METHODS: Patients aged 18-80 years, suffering from chronic peripheral neuropathic and/or nociceptive non-cancer pain were included (September 2013 to May 2017) and followed for six months. The primary outcome was the pain intensity difference (by visual analog scale score) between month 3 and baseline. The secondary outcomes, assessed at months 3 and 6, were SF36 score, analgesics consumption and number of TENS sessions performed at home (last seven days). RESULTS: Seventy-two patients were included, suffering from a combination of chronic non-cancer nociceptive and neuropathic pain, with a mean pain intensity of about sixty out of a hundred. The results show an important pain reduction (forty percent) in both groups at 3 months. No significant difference was observed between the control and intervention groups. Similarly, SF36 score, change in analgesic intake and patient compliance did not differ significantly between groups. CONCLUSIONS: This is the first randomized controlled study showing a decrease of pain intensity and a high level of compliance with transcutaneous electrical nerve stimulation alone or associated to hypnosis. The combination does not seem to be more efficient than transcutaneous electrical nerve stimulation alone. Chronic non-cancer pain remains a major issue and a substantial proportion of patients do not appear to benefit from interventions. IMPACT: This study increases our understanding of the combination of two non-pharmacological methods in chronic non-cancer pain patients. The combination of the two non-pharmacological strategies did not appear to be more efficient than one alone. Further research on non-pharmacological treatments targeting to patient's characteristics are needed to find appropriate strategies in patients with complex multidimensional pain conditions. Clinical Trial Number: NCT01944150 (Sept. 17, 2013).


Subject(s)
Chronic Pain , Hypnosis , Transcutaneous Electric Nerve Stimulation , Analgesics, Opioid , Chronic Pain/therapy , France , Humans , Quality of Life
9.
Eur J Anaesthesiol ; 35(10): 727-735, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29561278

ABSTRACT

BACKGROUND: Thoracic surgery for lung resection is associated with a high incidence of postoperative pulmonary complications. Controlled ventilation with a large tidal volume has been documented to be a risk factor for postoperative respiratory complications after major abdominal surgery, whereas the use of low tidal volumes and positive end-expiratory pressure (PEEP) has a protective effect. OBJECTIVE: To evaluate the effects of ventilation with low tidal volume and PEEP on major complications after thoracic surgery. DESIGN: A double-blind, randomised controlled study. SETTING: A multicentre trial from December 2008 to October 2011. PATIENTS: A total of 346 patients undergoing lobectomy or pneumonectomy for lung cancer. MAIN OUTCOME MEASURES: The primary outcome was the occurrence of major postoperative complications (pneumonia, acute lung injury, acute respiratory distress syndrome, pulmonary embolism, shock, myocardial infarction or death) within 30 days after surgery. INTERVENTIONS: Patients were randomly assigned to receive either lung-protective ventilation (LPV group) [tidal volume 5 ml kg ideal body weight + PEEP between 5 and 8 cmH2O] or nonprotective ventilation (control group) (tidal volume 10 ml kg ideal body weight without PEEP) during anaesthesia. RESULTS: The trial was stopped prematurely because of an insufficient inclusion rate. Major postoperative complications occurred in 23/172 patients in the LPV group (13.4%) vs. 38/171 (22.2%) in the control group (odds ratio 0.54, 95% confidence interval, 0.31 to 0.95, P = 0.03). The incidence of other complications (supraventricular cardiac arrhythmia, bronchial obstruction, pulmonary atelectasis, hypercapnia, bronchial fistula and persistent air leak) was also lower in the LPV group (37.2 vs. 49.4%, odds ratio 0.60, 95% confidence interval, 0.39 to 0.92, P = 0.02).The duration of hospital stay was shorter in the LPV group, 11 [interquartile range, 9 to 15] days vs. 12 [9 to 16] days, P = 0.048. CONCLUSION: Compared with high tidal volume and no PEEP, LPV combining low tidal volume and PEEP during anaesthesia for lung cancer surgery seems to improve postoperative outcomes. TRIALS REGISTRATION: ClinicalTrials.gov number: NCT00805077.


Subject(s)
Lung Neoplasms/surgery , Positive-Pressure Respiration/methods , Postoperative Complications/epidemiology , Respiration, Artificial/methods , Aged , Anesthesia/methods , Double-Blind Method , Female , Humans , Length of Stay , Male , Middle Aged , Prospective Studies , Thoracic Surgery/methods , Tidal Volume
10.
JAMA ; 313(23): 2331-9, 2015 Jun 16.
Article in English | MEDLINE | ID: mdl-25980660

ABSTRACT

IMPORTANCE: Noninvasive ventilation delivered as bilevel positive airway pressure (BiPAP) is often used to avoid reintubation and improve outcomes of patients with hypoxemia after cardiothoracic surgery. High-flow nasal oxygen therapy is increasingly used to improve oxygenation because of its ease of implementation, tolerance, and clinical effectiveness. OBJECTIVE: To determine whether high-flow nasal oxygen therapy was not inferior to BiPAP for preventing or resolving acute respiratory failure after cardiothoracic surgery. DESIGN AND SETTING: Multicenter, randomized, noninferiority trial (BiPOP Study) conducted between June 15, 2011, and January 15, 2014, at 6 French intensive care units. PARTICIPANTS: A total of 830 patients who had undergone cardiothoracic surgery, of which coronary artery bypass, valvular repair, and pulmonary thromboendarterectomy were the most common, were included when they developed acute respiratory failure (failure of a spontaneous breathing trial or successful breathing trial but failed extubation) or were deemed at risk for respiratory failure after extubation due to preexisting risk factors. INTERVENTIONS: Patients were randomly assigned to receive high-flow nasal oxygen therapy delivered continuously through a nasal cannula (flow, 50 L/min; fraction of inspired oxygen [FiO2], 50%) (n = 414) or BiPAP delivered with a full-face mask for at least 4 hours per day (pressure support level, 8 cm H2O; positive end-expiratory pressure, 4 cm H2O; FiO2, 50%) (n = 416). MAIN OUTCOMES AND MEASURES: The primary outcome was treatment failure, defined as reintubation, switch to the other study treatment, or premature treatment discontinuation (patient request or adverse effects, including gastric distention). Noninferiority of high-flow nasal oxygen therapy would be demonstrated if the lower boundary of the 95% CI were less than 9%. Secondary outcomes included mortality during intensive care unit stay, changes in respiratory variables, and respiratory complications. RESULTS: High-flow nasal oxygen therapy was not inferior to BiPAP: the treatment failed in 87 of 414 patients with high-flow nasal oxygen therapy (21.0%) and 91 of 416 patients with BiPAP (21.9%) (absolute difference, 0.9%; 95% CI, -4.9% to 6.6%; P = .003). No significant differences were found for intensive care unit mortality (23 patients with BiPAP [5.5%] and 28 with high-flow nasal oxygen therapy [6.8%]; P = .66) (absolute difference, 1.2% [95% CI, -2.3% to 4.8%]. Skin breakdown was significantly more common with BiPAP after 24 hours (10% vs 3%; 95% CI, 7.3%-13.4% vs 1.8%-5.6%; P < .001). CONCLUSIONS AND RELEVANCE: Among cardiothoracic surgery patients with or at risk for respiratory failure, the use of high-flow nasal oxygen therapy compared with intermittent BiPAP did not result in a worse rate of treatment failure. The findings support the use of high-flow nasal oxygen therapy in similar patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01458444.


Subject(s)
Hypoxia/therapy , Oxygen Inhalation Therapy/methods , Positive-Pressure Respiration , Postoperative Complications/therapy , Respiratory Insufficiency/therapy , Thoracic Surgical Procedures , Aged , Cardiac Surgical Procedures , Humans , Hypoxia/etiology , Middle Aged , Oxygen Inhalation Therapy/instrumentation , Respiratory Insufficiency/complications
11.
BMC Emerg Med ; 15: 21, 2015 Sep 04.
Article in English | MEDLINE | ID: mdl-26340941

ABSTRACT

BACKGROUND: Medical errors and preventable adverse events are a major cause of concern, especially in the emergency department (ED) where its prevalence has been reported to be roughly of 5-10% of visits. Due to a short length of stay, emergency patients are often managed by a sole physician - in contrast with other specialties where they can benefit from multiples handover, ward rounds and staff meetings. As some studies report that the rate and severity of errors may decrease when there is more than one physician involved in the management in different settings, we sought to assess the impact of regular systematic cross-checkings between physicians in the ED. DESIGN: The CHARMED (Cross-checking to reduce adverse events resulting from medical errors in the emergency department) study is a multicenter cluster randomized study that aim to evaluate the reduction of the rate of severe medical errors with implementation of systematic cross checkings between emergency physician, compared to a control period with usual care. This study will evaluate the effect of this intervention on the rate of severe medical errors (i.e. preventable adverse events or near miss) using a previously described two-level chart abstraction. We made the hypothesis that implementing frequent and systematic cross checking will reduce the rate of severe medical errors from 10 to 6% - 1584 patients will be included, 140 for each period in each center. DISCUSSION: The CHARMED study will be the largest study that analyse unselected ED charts for medical errors. This could provide evidence that frequent systematic cross-checking will reduce the incidence of severe medical errors. TRIAL REGISTRATION: Clinical Trials, NCT02356926.


Subject(s)
Emergency Service, Hospital/organization & administration , Medical Errors/prevention & control , Patient Safety , Clinical Protocols , Cross-Over Studies , Feasibility Studies , Humans , Models, Statistical
12.
Crit Care ; 18(5): 516, 2014 Sep 19.
Article in English | MEDLINE | ID: mdl-25246084

ABSTRACT

INTRODUCTION: There are little data about patients with cardiogenic shock (CS) who survive the early phase of acute myocardial infarction (AMI). The aim of this study was to assess long-term (5-year) mortality among early survivors of AMI, according to the presence of CS at the acute stage. METHODS: We analyzed 5-year follow-up data from the French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2005 registry, a nationwide French survey including consecutive patients admitted for ST or non-ST-elevation AMI at the end of 2005 in 223 institutions. RESULTS: Of 3670 patients enrolled, shock occurred in 224 (6.1%), and 3411 survived beyond 30 days or hospital discharge, including 99 (2.9%) with shock. Early survivors with CS had a more severe clinical profile, more frequent concomitant in-hospital complications, and were less often managed invasively than those without CS. CONCLUSIONS: In patients surviving the early phase of AMI, CS at the initial stage carries an increased risk of death up to one year after the acute event. Beyond one year, however, mortality is similar to that of patients without shock. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT00673036, Registered May 5, 2008.


Subject(s)
Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Registries , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/mortality , Aged , Aged, 80 and over , Female , Follow-Up Studies , France/epidemiology , Humans , Male , Middle Aged , Survival Rate/trends , Time Factors , Treatment Outcome
13.
JAMA Intern Med ; 183(12): 1378-1385, 2023 Dec 01.
Article in English | MEDLINE | ID: mdl-37930696

ABSTRACT

Importance: Patients in the emergency department (ED) who are waiting for hospital admission on a wheeled cot may be subject to harm. However, mortality and morbidity among older patients who spend the night in the ED while waiting for a bed in a medical ward are unknown. Objective: To assess whether older adults who spend a night in the ED waiting for admission to a hospital ward are at increased risk of in-hospital mortality. Design, Settings, and Participants: This was a prospective cohort study of older patients (≥75 years) who visited the ED and were admitted to the hospital on December 12 to 14, 2022, at 97 EDs across France. Two groups were defined and compared: those who stayed in the ED from midnight until 8:00 am (ED group) and those who were admitted to a ward before midnight (ward group). Main Outcomes and Measures: The primary end point was in-hospital mortality, truncated at 30 days. Secondary outcomes included in-hospital adverse events (ie, falls, infection, bleeding, myocardial infarction, stroke, thrombosis, bedsores, and dysnatremia) and hospital length of stay. A generalized linear-regression mixed model was used to compare end points between groups. Results: The total sample comprised 1598 patients (median [IQR] age, 86 [80-90] years; 880 [55%] female and 718 [45%] male), with 707 (44%) in the ED group and 891 (56%) in the ward group. Patients who spent the night in the ED had a higher in-hospital mortality rate of 15.7% vs 11.1% (adjusted risk ratio [aRR], 1.39; 95% CI, 1.07-1.81). They also had a higher risk of adverse events compared with the ward group (aRR, 1.24; 95% CI, 1.04-1.49) and increased median length of stay (9 vs 8 days; rate ratio, 1.20; 95% CI, 1.11-1.31). In a prespecified subgroup analysis of patients who required assistance with the activities of daily living, spending the night in the ED was associated with a higher in-hospital mortality rate (aRR, 1.81; 95% CI, 1.25-2.61). Conclusions and Relevance: The findings of this prospective cohort study indicate that for older patients, waiting overnight in the ED for admission to a ward was associated with increased in-hospital mortality and morbidity, particularly in patients with limited autonomy. Older adults should be prioritized for admission to a ward.


Subject(s)
Activities of Daily Living , Hospitalization , Humans , Male , Female , Aged , Aged, 80 and over , Prospective Studies , Emergency Service, Hospital , Hospital Mortality
14.
Eur Heart J Qual Care Clin Outcomes ; 9(2): 194-202, 2023 02 28.
Article in English | MEDLINE | ID: mdl-35612990

ABSTRACT

AIMS: To estimate the cost-effectiveness and cost-utility ratios of a restrictive vs. liberal transfusion strategy in acute myocardial infarction (AMI) patients with anaemia. METHODS AND RESULTS: Patients (n = 666) with AMI and haemoglobin between 7-8 and 10 g/dL recruited in 35 hospitals in France and Spain were randomly assigned to a restrictive (n = 342) or a liberal (n = 324) transfusion strategy with 1-year prospective collection of resource utilization and quality of life using the EQ5D3L questionnaire. The economic evaluation was based on 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular events (MACEs) averted as the effectiveness outcome. and a 1-year cost-utility ratio.The 30-day incremental cost-effectiveness ratio was €33 065 saved per additional MACE averted with the restrictive vs. liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE-reducing (i.e. dominant). At 1 year, the point estimate of the cost-utility ratio was €191 500 saved per quality-adjusted life year gained; however, the cumulated MACE was outside the pre-specified non-inferiority margin, resulting in a decremental cost-effectiveness ratio with a point estimate of €72 000 saved per additional MACE with the restrictive strategy. CONCLUSION: In patients with AMI and anaemia, the restrictive transfusion strategy was dominant (cost-saving and outcome-improving) at 30 days. At 1 year, the restrictive strategy remained cost-saving, but clinical non-inferiority on MACE was no longer maintained. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02648113. ONE SENTENCE SUMMARY: The use of a restrictive transfusion strategy in patients with acute myocardial infarction is associated with lower healthcare costs, but more evidence is needed to ascertain its long-term clinical impact.


Subject(s)
Anemia , Myocardial Infarction , Humans , Cost-Benefit Analysis , Quality of Life , Prospective Studies , Erythrocyte Transfusion/adverse effects , Erythrocyte Transfusion/methods , Anemia/etiology , Myocardial Infarction/therapy , Myocardial Infarction/etiology
15.
Eur J Emerg Med ; 29(5): 341-347, 2022 Oct 01.
Article in English | MEDLINE | ID: mdl-36062433

ABSTRACT

BACKGROUND: The optimal strategy for the diagnosis of pulmonary embolism (PE) in the emergency department (ED) remains debated. To reduce the need of imaging testing, several rules have been recently validated using an elevated D-dimer threshold. OBJECTIVE: To validate the safety of different diagnostic strategies and compare the efficacy in terms of chest imaging testing. DESIGN AND PATIENTS: Post-hoc analysis of individual data of 3330 adult patients without a high clinical probability of PE in the ED followed-up at 3 months in France and Spain (1916 from the PROPER cohort, 1414 from the MODIGLIANI cohort). EXPOSURE: Four diagnostic strategies with an elevated D-dimer threshold if PE is unlikely. The YEARS combined with Pulmonary Embolism Rule-out Criteria (PERC) the pulmonary embolism graduated D-dimer (PEGeD) combined with PERC and the 4-level pulmonary embolism probability score (4PEPS) rules were assessed. A modified simplified (MODS) rule with a simplified YEARS reduced to the sole item of "Is PE the most likely diagnosis" combined with PERC was also tested. OUTCOME MEASURE AND ANALYSIS: The primary outcome was the proportion of diagnosed PE or deep venous thrombosis at 3 months in patients in whom PE could have been excluded without chest imaging according to the tested strategy. The safety of a strategy was confirmed if the failure rate was less than 1.85%. The secondary outcome was the use of imaging testing according to each rule. RESULTS: Among 3330 analyzed patients, 150 (4.5%) had a PE. The number of missed PEs were 25, 29, 30 and 26 for the PERC+YEARS, PERC+PEGeD, 4PEPS and MODS rules respectively, with a failure rate of 0.75% (95% CI 0.51% to 1.10%), 0.87% (0.61% to 1.25%), 0.90% (0.63% to 1.28%) and 0.78% (0.53% to 1.14%) respectively. There was no significant difference in the failure rate between rules. Except for a significant lower use of chest imaging for 4PEPS compared to YEARS (14.9% vs 16.3%, difference -1.4% [95%CI -2.1% to -0.8%]), there was no difference in the proportion of imaging testing. CONCLUSION: In this post-hoc analysis of patients with suspicion of PE, YEARS and PEGeD combined with PERC, and 4PEPS were safe to exclude PE. The safety of the modified simplified MODS strategy was also confirmed. There was no significant difference of the failure rate between strategies.


Subject(s)
Pulmonary Embolism , Adult , Humans , Cohort Studies , Emergency Service, Hospital , Pulmonary Embolism/diagnosis , Spain
16.
BMJ Open ; 12(3): e056169, 2022 03 22.
Article in English | MEDLINE | ID: mdl-35318234

ABSTRACT

INTRODUCTION: Patients with erosive hand osteoarthritis (EHOA) experience pain and inflammation, two features that can be targeted by vagus nerve stimulation using electrical auricular transcutaneous vagus nerve stimulation (tVNS). A pilot study demonstrated the feasibility of the procedure, so we designed a randomised sham-controlled trial to determine the safety and efficacy of tVNS in EHOA. METHODS AND ANALYSIS: ESTIVAL Study (Essai randomisé comparant la STImulation auriculaire transcutanée du nerf Vague versus sham stimulation dans l'Arthrose DigitaLe Érosive symptomatique et inflammatoire) is a superiority, randomised, double-blind sham-controlled trial comparing two parallel arms: active and sham tVNSs in a 1:1 ratio. Patients with symptomatic EHOA (score ≥40/100 mm on a visual analogue scale (VAS) for pain of 0-100 mm) and inflammatory EHOA (≥1 clinical and ultrasonography-determined interphalangeal synovitis) are included in 18 hospital centres (17 rheumatology and 1 rehabilitation departments) in France. Active and sham tVNSs use an auricular electrode connected to the Vagustim device, with no electric current delivered in the sham group. Patients undergo stimulation for 20 min/day for 12 weeks. The follow-up visits take place at weeks 4, 8 and 12. The enrolment duration is 2 years and started in April 2021; 156 patients are scheduled to be included. The primary outcome is the difference in self-reported hand pain in the previous 48 hours measured on a VAS of 0-100 mm between baseline and week 12. Secondary outcomes include other pain outcomes, function, quality of life, serum biomarker levels, compliance and tolerance. For a subset of patients, MRI of the hand is performed at baseline and week 12 to compare the change in Outcome Measures in Rheumatology/Hand Osteoarthritis MRI Scoring System subscores. The primary analysis will be performed at the end of the study according to the intent-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval was obtained from the institutional review board (Comité de Protection des Personnes, 2020-A02213-36). All participants will be required to provide written informed consent. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04520516; Pre-results. PROTOCOL VERSION AND NUMBER: V.2 of 11 March 2021.


Subject(s)
Osteoarthritis , Vagus Nerve Stimulation , Double-Blind Method , Humans , Pain , Pilot Projects , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome
17.
EClinicalMedicine ; 48: 101444, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35582124

ABSTRACT

Background: Although effective mRNA vaccines for SARS-CoV-2 infection have been deployed worldwide, their interchangeability could facilitate the scale-up of vaccination programs. The objective of the trial was to assess whether the immune response induced by a heterologous SARS-CoV-2 mRNA primo vaccination is non-inferior to that of a homologous mRNA vaccination. Methods: We conducted a multicenter, randomized, open-label trial in adults 18 years of age and older who received a first dose of SARS-CoV-2 mRNA vaccine. Participants were randomly assigned in a 1:1 ratio to receive a second dose of BNT162b2 or mRNA-1273, 28 to 49 days after the first dose. Randomization was stratified on the vaccine received at the first vaccination. The primary endpoint was the anti-spike IgG antibodies titer measured 28 days after the second vaccine dose. This study is registered with ClinicalTrials.gov, Trial, NCT04900467. Findings: Of the 414 randomized participants recruited from May 28 to July 2, 2021, 390 were included in the per protocol analysis: 94 participants in group 1 (BNT162b2/BNT162b2), 96 in group 2 (BNT162b2/mRNA-1273), 97 in group 3 (mRNA-1273/mRNA-1273), and 103 in group 4 (mRNA-1273/BNT162b2). The geometric mean titers ratios of anti-spike IgG antibodies for each heterologous regimen relative to the corresponding homologous regimen were 1·37 (two-sided 95% CI, 1·10 to 1·72) in the groups 1 and 2 and 0·67 (two-sided 95% CI, 0·55 to 0·82) in the groups 3 and 4. Levels of neutralizing antibodies to the main circulating SARS-Cov-2 viral strains were higher with the vaccine regimen containing mRNA-1273. Participants who received mRNA-1273 as a second dose experienced a higher rate of local adverse reactions and general symptoms than those who received BNT162b2 (p < 0·0001). Interpretation: The two SARS-CoV-2 mRNA vaccines could be used with flexibility for the second dose of COVID-19 primo vaccination. Tolerance remains good regardless of vaccine sequence although mRNA-1273 was more reactogenic. Funding: French Ministries of Solidarity and Health and Research. BNT162b2 was provided by Pfizer/BioNTech. mRNA-1273 was provided by Moderna.

18.
Lancet Respir Med ; 10(1): 26-34, 2022 01.
Article in English | MEDLINE | ID: mdl-34506761

ABSTRACT

BACKGROUND: The use of cyclophosphamide in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) is unknown. Our study was designed to evaluate the efficacy and safety of four cyclophosphamide pulses in addition to high-dose methylprednisolone in this population. METHODS: In this double-blind, placebo-controlled trial done in 35 departments across 31 hospitals in France, adult patients (≥18 years) with acute exacerbation of IPF and those with suspected acute exacerbation of IPF were randomly assigned in a 1:1 ratio using a web-based system to receive either intravenous pulses of cyclophosphamide (600 mg/m2) plus uromitexan as haemorrhagic cystitis prophylaxis (200 mg/m2) at the time of cyclophosphamide administration and then again, 4 h later, or placebo at days 0, 15, 30, and 60. Random assignment was stratified according to the severity of IPF and was block-balanced with variable block sizes of four or six patients. Patients receiving mechanical ventilation, with active infection, with active cancer, or who were registered on the lung transplant waiting list were excluded. All patients received standardised high-dose glucocorticoids. The investigators, patients, and the sponsor were masked to the treatment assignments. The primary endpoint was 3-month all-cause mortality, analysed by a χ2 test adhering to an intention-to-treat principle. The trial is now complete and registered with ClinicalTrials.gov, NCT02460588. FINDINGS: Between Jan 22, 2016, and July 19, 2018, 183 patients were assessed for eligibility, of whom 120 patients were randomly assigned and 119 patients (62 [52%] with severe IPF) received at least one dose of cyclophosphamide (n=60) or placebo (n=59), all of whom were included in the intention-to-treat analysis. The 3-month all-cause mortality was 45% (27/60) in patients given cyclophosphamide compared with 31% (18/59) in the placebo group (difference 14·5% [95% CI -3·1 to 31·6]; p=0·10). Similar results were found after adjustment by IPF severity (odds ratio [OR] 1·89 [95% CI 0·89-4·04]). The risk of death at 3 months, independent of the treatment received, was higher with severe than non-severe IPF (OR 2·62 [1·12-6·12]) and was lower with the use of antifibrotic therapy (OR 0·33 [0·13-0·82]). Adverse events were similar between groups by 6 months (25 [42%] in the cyclophosphamide group vs 30 [51%] in the placebo group) and their proportion, including infections, did not differ. Overall infection was the main adverse event and occurred in 20 (33%) of 60 patients in the cyclophosphamide group versus 21 (36%) of 59 patients in the placebo group. INTERPRETATION: In patients with acute exacerbation of IPF, adding intravenous cyclophosphamide pulses to glucocorticoids increased 3-month mortality. These findings provide evidence against the use of intravenous cyclophosphamide in such patients. FUNDING: Programme Hospitalier de Recherche Clinique of the French Ministry of Health (PHRC 2014-502), Roche Pharmaceuticals.


Subject(s)
Glucocorticoids , Idiopathic Pulmonary Fibrosis , Adult , Cyclophosphamide/adverse effects , Double-Blind Method , Glucocorticoids/adverse effects , Humans , Idiopathic Pulmonary Fibrosis/drug therapy , Treatment Outcome
19.
BMJ Open ; 11(8): e048187, 2021 08 18.
Article in English | MEDLINE | ID: mdl-34408046

ABSTRACT

INTRODUCTION: At the time of the worrying emergence and spread of bacterial resistance, reducing the selection pressure by reducing the exposure to antibiotics in patients with community-acquired pneumonia (CAP) is a public health issue. In this context, the combined use of molecular tests and biomarkers for guiding antibiotics discontinuation is attractive. Therefore, we have designed a trial comparing an integrated approach of diagnosis and treatment of severe CAP to usual care. METHODS AND ANALYSIS: The multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe-CAP (MULTI-CAP) trial is a multicentre (n=20), parallel-group, superiority, open-label, randomised trial. Patients are included if adult admitted to intensive care unit for a CAP. Diagnosis of pneumonia is based on clinical criteria and a newly appeared parenchymal infiltrate. Immunocompromised patients are excluded. Subjects are randomised (1:1 ratio) to either the intervention arm (experimental strategy) or the control arm (usual strategy). In the intervention arm, the microbiological diagnosis combines a respiratory multiplex PCR (mPCR) and conventional microbiological investigations. An algorithm of early antibiotic de-escalation or discontinuation is recommended, based on mPCR results and the procalcitonin value. In the control arm, only conventional microbiological investigations are performed and antibiotics de-escalation remains at the clinician's discretion. The primary endpoint is the number of days alive without any antibiotic from the randomisation to day 28. Based on our hypothesis of 2 days gain in the intervention arm, we aim to enrol a total of 450 patients over a 30-month period. ETHICS AND DISSEMINATION: The MULTI-CAP trial is conducted according to the principles of the Declaration of Helsinki, is registered in Clinical Trials and has been approved by the Committee for Protection of Persons and the National French Drug Safety Agency. Written informed consents are obtained from all the patients (or representatives). The results will be disseminated through educational institutions, submitted to peer-reviewed journals for publication and presented at medical congresses. TRIAL REGISTRATION NUMBER: NCT03452826; Pre-results.


Subject(s)
COVID-19 , Pneumonia , Adult , Anti-Bacterial Agents/therapeutic use , Humans , Intensive Care Units , Multiplex Polymerase Chain Reaction , Pneumonia/drug therapy , Procalcitonin
20.
Microbiome ; 8(1): 12, 2020 02 03.
Article in English | MEDLINE | ID: mdl-32014035

ABSTRACT

BACKGROUND: The role of the gut microbiota in Crohn's disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileo-colonic CD. METHOD: Patients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either FMT or sham transplantation during a colonoscopy. Corticosteroids were tapered and a second colonoscopy was performed at week 6. The primary endpoint was the implantation of the donor microbiota at week 6 (Sorensen index > 0.6). RESULTS: Eight patients received FMT and nine sham transplantation. None of the patients reached the primary endpoint. The steroid-free clinical remission rate at 10 and 24 weeks was 44.4% (4/9) and 33.3% (3/9) in the sham transplantation group and 87.5% (7/8) and 50.0% (4/8; one patient loss of follow-up while in remission at week 12 and considered in flare at week 24) in the FMT group. Crohn's Disease Endoscopic Index of Severity decreased 6 weeks after FMT (p = 0.03) but not after sham transplantation (p = 0.8). Conversely, the CRP level increased 6 weeks after sham transplantation (p = 0.008) but not after FMT (p = 0.5). Absence of donor microbiota engraftment was associated with flare. No safety signal was identified. CONCLUSION: The primary endpoint was not reached for any patient. In this pilot study, higher colonization by donor microbiota was associated with maintenance of remission. These results must be confirmed in larger studies (NCT02097797). Video abstract.


Subject(s)
Crohn Disease/therapy , Fecal Microbiota Transplantation , Adrenal Cortex Hormones/therapeutic use , Adult , Feces/microbiology , Female , Humans , Male , Microbiota , Pilot Projects , Remission Induction , Research Design , Severity of Illness Index , Single-Blind Method , Treatment Outcome
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