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AIM: Although uncommon, infections associated with peripheral intravenous catheters (PIVCs) may be responsible for severe life-threatening complications and increase healthcare costs. Few data are available on the relationship between PIVC insertion site and risk of infectious complications. METHODS: We performed a post hoc analysis of the CLEAN 3 database, a randomized 2 × 2 factorial study comparing two skin disinfection procedures (2% chlorhexidine-alcohol or 5% povidone iodine-alcohol) and two types of medical devices (innovative or standard) in 989 adults patients requiring PIVC insertion before admission to a medical ward. Insertion sites were grouped into five areas: hand, wrist, forearm, cubital fossa and upper arm. We evaluated the risk of risk of PIVC colonization (i.e., tip culture eluate in broth showing at least one microorganism in a concentration of at least 1000 Colony Forming Units per mL) and/or local infection (i.e., organisms growing from purulent discharge at PIVC insertion site with no evidence of associated bloodstream infection), and the risk of positive PIVC tip culture (i.e., PIVC-tip culture eluate in broth showing at least one microorganism regardless of its amount) using multivariate Cox models. RESULTS: Eight hundred twenty three PIVCs with known insertion site and sent to the laboratory for quantitative culture were included. After adjustment for confounding factors, PIVC insertion at the cubital fossa or wrist was associated with increased risk of PIVC colonization and/or local infection (HR [95% CI], 1.64 [0.92-2.93] and 2.11 [1.08-4.13]) and of positive PIVC tip culture (HR [95% CI], 1.49 [1.02-2.18] and 1.59 [0.98-2.59]). CONCLUSION: PIVC insertion at the wrist or cubital fossa should be avoided whenever possible to reduce the risk of catheter colonization and/or local infection and of positive PIVC tip culture.
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Infecciones Relacionadas con Catéteres , Cateterismo Periférico , Humanos , Femenino , Masculino , Cateterismo Periférico/efectos adversos , Infecciones Relacionadas con Catéteres/prevención & control , Infecciones Relacionadas con Catéteres/microbiología , Persona de Mediana Edad , Anciano , Clorhexidina , Adulto , Desinfección/métodos , Povidona Yodada , Factores de Riesgo , Antiinfecciosos Locales , Contaminación de Equipos , Muñeca/microbiologíaRESUMEN
BACKGROUND: Patients with acute brain injury are at high risk of ventilator-associated pneumonia (VAP). The benefit of short-term antibiotic prophylaxis remains debated. We aimed to establish the effect of an early, single dose of the antibiotic ceftriaxone on the incidence of early VAP in patients with severe brain injury who required mechanical ventilation. METHODS: PROPHY-VAP was a multicentre, randomised, double-blind, placebo-controlled, assessor-masked, superiority trial conducted in nine intensive care units in eight French university hospitals. We randomly assigned comatose (Glasgow Coma Scale score [GCS] ≤12) adult patients (age ≥18 years) who required mechanical ventilation for at least 48 h after acute brain injury to receive intravenous ceftriaxone 2 g or placebo once within the 12 h following tracheal intubation. Participants did not receive selective oropharyngeal and digestive tract decontamination. The primary outcome was the proportion of patients developing early VAP from the 2nd to the 7th day of mechanical ventilation, confirmed by masked assessors. The analysis was reported in the modified intention-to-treat population, which comprised all randomly assigned patients except those who withdrew or did not give consent to continue and those who did not receive the allocated treatment because they met a criterion for non-eligibility. The trial is registered with ClinicalTrials.gov, NCT02265406. FINDINGS: From Oct 14, 2015, to May 27, 2020, 345 patients were randomly assigned (1:1) to receive ceftriaxone (n=171) or placebo (n=174); 330 received the allocated intervention and 319 were included in the analysis (162 in the ceftriaxone group and 157 in the placebo group). 166 (52%) participants in the analysis were men and 153 (48%) were women. 15 patients did not receive the allocated intervention after randomisation and 11 withdrew their consent. Adjudication confirmed 93 cases of VAP, including 74 early infections. The incidence of early VAP was lower in the ceftriaxone group than in the placebo group (23 [14%] vs 51 [32%]; hazard ratio 0·60 [95% CI 0·38-0·95], p=0·030), with no microbiological impact and no adverse effects attributable to ceftriaxone. INTERPRETATION: In patients with acute brain injury, a single ceftriaxone dose decreased the risk of early VAP. On the basis of our findings, we recommend that an early, single dose of ceftriaxone be included in all bundles for the prevention of VAP in patients with brain injury who require mechanical ventilation. FUNDING: French Ministry of Social Affairs and Health.
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Antibacterianos , Ceftriaxona , Neumonía Asociada al Ventilador , Respiración Artificial , Humanos , Ceftriaxona/administración & dosificación , Ceftriaxona/uso terapéutico , Neumonía Asociada al Ventilador/prevención & control , Femenino , Masculino , Método Doble Ciego , Persona de Mediana Edad , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Respiración Artificial/efectos adversos , Adulto , Anciano , Profilaxis Antibiótica/métodos , Lesiones Encefálicas/complicaciones , Lesiones Encefálicas/prevención & control , Francia , Unidades de Cuidados Intensivos , Intubación Intratraqueal/efectos adversos , Resultado del TratamientoRESUMEN
The use of arterial catheters is frequent in intensive care for hemodynamic monitoring of patients and for blood sampling, but they are often removed because of dysfunction. The primary objective is to compare the prevalence of radial arterial catheter dysfunction according to location in relation to the radiocarpal joint in intensive care patients. DESIGN: Prospective randomized, controlled, single-center study. SETTING: The surgical ICU of the university hospital of Poitiers in France. PATIENTS: From January 2016 to April 2017, all patients over 18 years old admitted to the surgical ICU and requiring an arterial catheter were included. INTERVENTIONS: Randomization into two groups: catheter placed near the wrist (within 4 cm of the radiocarpal joint) and catheter placed away the wrist. The primary endpoint was the prevalence of dysfunction. We also compared the prevalence of infection and colonization. MEASUREMENTS AND MAIN RESULTS: One hundred seven catheters were analyzed (14 failed placements with no difference between the two groups, and 16 catheters excluded for missing data), with 58 catheters in near the wrist group and 49 in away the wrist group. We did not find any significant difference in the number of catheter dysfunctions between the two groups (p = 0.56). The prevalence density of catheter dysfunction was 30.5 of 1,000 catheter days for near the wrist group versus 26.7 of 1,000 catheter days for away the wrist group. However, we observed a significant difference in terms of catheter-related infection in favor of away the wrist group (p = 0.04). In addition, distal positioning of the catheter was judged easier by the physicians. CONCLUSIONS: The distal or proximal position of the arterial catheter in the radial position has no influence on the occurrence of dysfunction. However, there may be an association with the prevalence of infections.
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OBJECTIVES: Ceftaroline could be suitable to treat early-onset ventilator-associated pneumonia (VAP) because of its antibacterial spectrum. However, augmented renal clearance (ARC) is frequent in ICU patients and may affect ceftaroline pharmacokinetics and efficacy. The objective of the study was to explore the impact of ARC on ceftaroline pharmacokinetics and evaluate whether the currently recommended dosing regimen (600â mg every 12â h) is appropriate to treat VAP in ICU patients. METHODS: A population pharmacokinetic model was developed using pharmacokinetic data from 18 patients with measured creatinine clearance (CLCR) ranging between 83 and 309â mL/min. Monte Carlo simulations were conducted to determine the PTA and the cumulative fraction of response (CFR) against Streptococcus pneumoniae and MRSA for five dosing regimens. Study registered at ClinicalTrials.gov (NCT03025841). RESULTS: Ceftaroline clearance increased non-linearly with CLCR, with lower concentrations and lower probability of reaching pharmacokinetic/pharmacodynamic targets when CLCR increases. For the currently recommended dosing regimen, the probability of having unbound ceftaroline concentrations above the MIC over the entire dose range is greater than 90% for MICs below 0.125â mg/L. Considering the distribution of MICs, this regimen would not be effective against MRSA infections (CFR between 21% and 67% depending on CLCR), but would be effective against S. pneumoniae infections (CFR >86%). CONCLUSIONS: The recommended dosing regimen of ceftaroline seems sufficient for covering S. pneumoniae in ICU patients with ARC, but not for MRSA. Among the dosing regimens tested it appears that a constant infusion (50â mg/h) after a loading dose of 600â mg could be more appropriate for MRSA infections.
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Staphylococcus aureus Resistente a Meticilina , Neumonía , Insuficiencia Renal , Humanos , Antibacterianos , Cefalosporinas , Cuidados Críticos , Pruebas de Sensibilidad Microbiana , Método de Montecarlo , Neumonía/tratamiento farmacológico , Streptococcus pneumoniae , CeftarolinaRESUMEN
INTRODUCTION: Little is known about the bloodstream infection (BSI) risk associated with short-term peripheral venous catheters (PVCs) and no large study investigated the insertion site-related risk for PVC-BSI. METHODS: We performed a cohort study at the University of Geneva Hospitals using the prospective hospital-wide BSI surveillance database. We analyzed the association between insertion site and risk of PVC-BSI on the upper extremity using univariable and multivariable marginal Cox models. RESULTS: Between 2016 and 2020, utilization of 403'206 peripheral venous catheters were prospectively recorded in a 2000-bed hospital consortium with ten sites. Twenty-seven percent of PVC (n = 109'686) were inserted in the hand. After adjustment for confounding factors, hand insertion was associated with a decreased PVC-BSI risk (adjusted hazard ratio [HR] 0.42, 95% CI 0.18-0.98, p = 0.046) compared to more proximal insertion sites. In a sensitivity analysis for PVCs with ≥ 3 days of dwell time, we confirmed a decreased PVC-BSI risk after hand insertion (HR 0.37, 95% CI 0.15-0.93, p = 0.035). CONCLUSION: Hand insertion should be considered for reducing PVC infections, especially for catheters with an expected dwell time of more than 2 days.
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Infecciones Relacionadas con Catéteres , Infección Hospitalaria , Sepsis , Humanos , Infecciones Relacionadas con Catéteres/epidemiología , Catéteres , Estudios de Cohortes , Infección Hospitalaria/epidemiología , Estudios Prospectivos , Sepsis/epidemiologíaRESUMEN
The objective of the study was to perform a cost-effectiveness analysis of bundled devices (BDs) versus standard devices (SDs) for the prevention of unscheduled peripheral venous catheter (PVC) removal due to complication from a French investigator-initiated, open-label, single center, randomized-controlled, two-by-two factorial trial (CLEAN-3 study). A 14-day time non homogeneous semi-markovian model was performed to be fitted to longitudinal individual patient data from CLEAN-3 database. This model includes five health states and eight transitional events; a base case scenario, two scenario analyses and bootstrap sensitivity analyses were performed. The cost-effectiveness criterion was the cost per patient with unscheduled PVC removal avoided. 989 adult (age≥18 years) patients were analyzed to compare the BDs group (494 patients), and the SDs group (495 patients). The assessed intervention was a combination of closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes compared with the use of open catheters and three-way stopcocks for treatment administration. For the base case scenario, an unscheduled 1st PVC removal before discharge was significantly more frequent in the SDs group (235 patients (47.5%) in the SDs group and 172 patients (34.8%) in the BDs group, p = 0.00006). After adjustment for 1st catheter time, the number of patients with unscheduled PVC removal per day was of 16 (95%CI: 15; 18) patients (out of 100) in the BDs group and of 26 (95%CI: 24; 28) patients (out of 100) in the SDs group. The mean cost per patient (adjusted on catheter-time) was of 144 (95%CI: 135-154) for patients in the SDs group versus 102 (95%CI: 95-109) for patients in the BDs group; the mean saving per patient was of 42 (95%CI: 32-54). As a consequence, the assessed BDs strategy was less costly and more effective than the SDs strategy. Trail registration: CLEAN-3 study is registered with ClinicalTrials.gov, NCT03757143.
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Infecciones Relacionadas con Catéteres , Cateterismo Periférico , Adolescente , Adulto , Humanos , Infecciones Relacionadas con Catéteres/prevención & control , Cateterismo Periférico/efectos adversos , Catéteres , Análisis Costo-BeneficioRESUMEN
Global emergence of multidrug-resistant and extensive drug-resistant gram-negative bacteria has increased the risk of treatment failure, especially for healthcare- or ventilator-associated pneumonia (HAP/VAP). Nebulization of antibiotics, by providing high intrapulmonary antibiotic concentrations, represents a promising approach to optimize the treatment of HAP/VAP due to multidrug-resistant and extensive drug-resistant gram-negative bacteria, while limiting systemic antibiotic exposure. Aminoglycosides and colistin methanesulfonate are the most common nebulized antibiotics. Although optimal nebulized drug dosing regimen is not clearly established, high antibiotic doses should be administered using vibrating-mesh nebulizer with optimized ventilator settings to ensure safe and effective intrapulmonary concentrations. When used preventively, nebulized antibiotics reduced the incidence of VAP without any effect on mortality. This approach is not yet recommended and large randomized controlled trials should be conducted to confirm its benefit and explore the impact on antibiotic selection pressure. Compared with high-dose intravenous administration, high-dose nebulized colistin methanesulfonate seems to be more effective and safer in the treatment of ventilator-associated tracheobronchitis and VAP caused by multidrug resistant and extensive-drug resistant gram-negative bacteria. Adjunctive nebulized aminoglycosides could increase the clinical cure rate and bacteriological eradication in patients suffering from HAP/VAP due to multidrug-resistant and extensive drug-resistant gram-negative bacteria. As nebulized aminoglycosides broadly diffuse in the systemic circulation of patients with extensive bronchopneumonia, monitoring of plasma trough concentrations is recommended during the period of nebulization. Large randomized controlled trials comparing high dose of nebulized colistin methanesulfonate to high dose of intravenous colistin methanesulfonate or to intravenous new ß-lactams in HAP/VAP due to multidrug-resistant and extensive drug-resistant gram-negative bacteria are urgently needed.
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Neumonía Asociada al Ventilador , Aminoglicósidos/farmacología , Aminoglicósidos/uso terapéutico , Antibacterianos/uso terapéutico , Colistina/farmacología , Colistina/uso terapéutico , Atención a la Salud , Bacterias Gramnegativas , Humanos , Neumonía Asociada al Ventilador/microbiologíaRESUMEN
OBJECTIVE: To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery. DESIGN: Phase III, randomised, double blind, placebo controlled trial. SETTING: 34 centres in France, December 2017 to March 2019. PARTICIPANTS: 1222 adults (>50 years) requiring major non-cardiac surgery with an expected duration of more than 90 minutes. The anticipated time frame for recruitment was 24 months. INTERVENTIONS: Participants were randomised to receive either dexamethasone (0.2 mg/kg immediately after the surgical procedure, and on day 1) or placebo. Randomisation was stratified on the two prespecified criteria of cancer and thoracic procedure. MAIN OUTCOMES MEASURES: The primary outcome was a composite of postoperative complications or all cause mortality within 14 days after surgery, assessed in the modified intention-to-treat population (at least one treatment administered). RESULTS: Of the 1222 participants who underwent randomisation, 1184 (96.9%) were included in the modified intention-to-treat population. 14 days after surgery, 101 of 595 participants (17.0%) in the dexamethasone group and 117 of 589 (19.9%) in the placebo group had complications or died (adjusted odds ratio 0.81, 95% confidence interval 0.60 to 1.08; P=0.15). In the stratum of participants who underwent non-thoracic surgery (n=1038), the primary outcome occurred in 69 of 520 participants (13.3%) in the dexamethasone group and 93 of 518 (18%) in the placebo group (adjusted odds ratio 0.70, 0.50 to 0.99). Adverse events were reported in 288 of 613 participants (47.0%) in the dexamethasone group and 296 of 609 (48.6%) in the placebo group (P=0.46). CONCLUSIONS: Dexamethasone was not found to significantly reduce the incidence of complications and death in patients 14 days after major non-cardiac surgery. The 95% confidence interval for the main result was, however, wide and suggests the possibility of important clinical effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov NCT03218553.
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Antiinflamatorios/administración & dosificación , Dexametasona/administración & dosificación , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/prevención & control , Anciano , Método Doble Ciego , Esquema de Medicación , Femenino , Francia , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Tempo Operativo , Cuidados PosoperatoriosRESUMEN
We report data regarding three countries with similar healthcare systems which had three different vaccinal strategies between 1st of January and 10th of April 2021: rapid full vaccination (Israel), rapid first-dose vaccination (United Kingdom) and a delayed vaccination strategy (France).
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Vacunas contra la COVID-19/administración & dosificación , COVID-19/prevención & control , Hospitalización/estadística & datos numéricos , Programas de Inmunización/estadística & datos numéricos , Brasil , COVID-19/virología , Francia , Humanos , Programas de Inmunización/métodos , Esquemas de Inmunización , Israel , SARS-CoV-2/inmunología , Sudáfrica , Reino UnidoRESUMEN
BACKGROUND: Ventilator-associated pneumonia (VAP) is the most frequent health care-associated infection in severely ill patients, and aspiration of contaminated oropharyngeal content around the cuff of the tracheal tube is the main route of contamination. RESEARCH QUESTION: Is continuous regulation of tracheal cuff pressure using a pneumatic device superior to manual assessment three times daily using a portable manometer (routine care) in preventing VAP in patients with severe trauma? STUDY DESIGN AND METHODS: In this open-label, randomized controlled superiority trial conducted in 13 French ICUs, adults (age ≥ 18 years) with severe trauma (Injury Severity Score > 15) and requiring invasive mechanical ventilation for ≥ 48 h were enrolled. Patients were randomly assigned (1:1) via a secure Web-based random number generator in permuted blocks of variable sizes to one of two groups according to the method of tracheal cuff pressure control. The primary outcome was the proportion of patients developing VAP within 28 days following the tracheal intubation, as determined by two assessors masked to group assignment, in the modified intention-to-treat population. This study is closed to new participants. RESULTS: A total of 434 patients were recruited between July 31, 2015, and February 15, 2018, of whom 216 were assigned to the intervention group and 218 to the control group. Seventy-three patients (33.8%) developed at least one episode of VAP within 28 days following the tracheal intubation in the intervention group compared with 64 patients (29.4%) in the control group (adjusted subdistribution hazard ratio, 0.96; 95% CI, 0.76-1.20; P = .71). No serious adverse events related to the use of the pneumatic device were noted. INTERPRETATION: Continuous regulation of cuff pressure of the tracheal tube using a pneumatic device was not superior to routine care in preventing VAP in patients with severe trauma. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT02534974; URL: www.clinicaltrials.gov.
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Intubación Intratraqueal/instrumentación , Neumonía Asociada al Ventilador/prevención & control , Respiración Artificial/instrumentación , Adulto , Femenino , Francia , Humanos , Puntaje de Gravedad del Traumatismo , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Presión , TráqueaRESUMEN
BACKGROUND: Two billion peripheral venous catheters are sold globally each year, but the optimal skin disinfection and types of devices are not well established. We aimed to show the superiority of disinfection with 2% chlorhexidine plus alcohol over 5% povidone iodine plus alcohol in preventing infectious complications, and of closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes used in combination (innovation group) over open catheters and three-way stopcocks for treatment administration (standard group) in preventing catheter failure. METHODS: We did an open-label, randomised-controlled trial with a two-by-two factorial design, for which we enrolled adults (age ≥18 years) visiting the emergency department at the Poitiers University Hospital, France, and requiring one peripheral venous catheter before admission to the medical wards. Before catheter insertion, patients were randomly assigned (1:1:1:1) using a secure web-based random-number generator to one of four treatment groups based on skin preparation and type of devices (innovative devices or standard devices; 2% chlorhexidine plus alcohol or 5% povidone iodine plus alcohol). Primary outcomes were the incidence of infectious complications (local infection, catheter colonisation, or bloodstream infections) and time between catheter insertion and catheter failure (occlusion, dislodgment, infiltration, phlebitis, or infection). This study is registered with ClinicalTrials.gov, NCT03757143. FINDINGS: 1000 patients were recruited between Jan 7, and Sept 6, 2019, of whom 500 were assigned to the chlorhexidine plus alcohol group and 500 to the povidone iodine plus alcohol group (250 with innovative solutions and 250 with standard devices in each antiseptic group). No significant interaction was found between the two study interventions. Local infections occurred less frequently with chlorhexidine plus alcohol than with povidone iodine plus alcohol (0 [0%] of 496 patients vs six [1%] of 493 patients) and the same was observed for catheter colonisation (4/431 [1%] vs 70/415 [17%] catheters among the catheters cultured; adjusted subdistribution hazard ratio 0·08 [95% CI 0·02-0·18]). Median time between catheter insertion and catheter failure was longer in the innovation group compared with the standard group (50·4 [IQR 29·6-69·4] h vs 30·0 [16·6-52·6] h; p=0·0017). Minor skin reactions occurred in nine (2%) patients in the chlorhexidine plus alcohol group and seven (1%) patients in the povidone iodine plus alcohol group. INTERPRETATION: For skin antisepsis, chlorhexidine plus alcohol provides greater protection of peripheral venous catheter-related infectious complications than does povidone iodine plus alcohol. Use of innovative devices extends the catheter complication-free dwell time. FUNDING: Becton Dickinson.
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Antiinfecciosos Locales/uso terapéutico , Infecciones Relacionadas con Catéteres/prevención & control , Cateterismo Periférico/efectos adversos , Clorhexidina/uso terapéutico , Desinfección/estadística & datos numéricos , Contaminación de Equipos , Etanol/uso terapéutico , Povidona Yodada/uso terapéutico , Anciano , Contaminación de Equipos/prevención & control , Contaminación de Equipos/estadística & datos numéricos , Femenino , Humanos , MasculinoRESUMEN
INTRODUCTION: Prolonged fasting before surgery is common in pediatrics. In the literature, it is responsible for hypotension, irritability and postoperative nausea and vomiting. Despite clear instructions given during the preanesthetic consultation, fasting rules are respected in only 30%-40% of cases. We aimed to evaluate the benefit of sending a text message the day before surgery to improve the parents' observance of fasting rules. METHODS: We conducted a before-and-after study at the University Hospital of Poitiers. From August to October 2018, 172 parents of children under 15 years of age scheduled for all types of surgery were enrolled into two groups according to the period: the control group with parents receiving information on preoperative fasting rules during the preanesthetic consultation several days before surgery, and the text message group, receiving the same information during consultation plus a text message the day before the surgery. RESULTS: There was a difference in observance of clear fluid fasting instructions (between 2 and 3 h before the admission at hospital) in favor of the text message group 33% versus 92% OR 29.2 (10.9-95.2) p < 0.001, and in average fasting time for clear fluids 8.7 h ± 4.8 h vs. 4.3 h ± 2.4 h (p < 0.001). CONCLUSION: Sending of a reminder text message to the parents the day before the surgery resulted in a significant increase in observance of fasting rules in children undergoing scheduled surgery.