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1.
Antimicrob Resist Infect Control ; 11(1): 67, 2022 05 07.
Article in English | MEDLINE | ID: covidwho-1833352

ABSTRACT

BACKGROUND: The COVID-19 pandemic may have had a substantial impact on the incidence of device-associated healthcare-associated infections (HAI), in particular in intensive care units (ICU). A significant increase of HAI was reported by US hospitals when comparing incidence rates from 2019 and 2020. The objective of this study was to investigate the development of the most relevant device-associated HAI in German ICUs during the year 2020 as compared to 2019. METHODS: We utilized the data of the ICU component of the German National Reference Center for Surveillance of Nosocomial Infections (KISS = Krankenhaus-Infektions-Surveillance-System) for the period 2019-2020. We focused on central line-associated bloodstream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), ventilator-associated lower respiratory infections (VALRTI) and bloodstream infections associated with the use of Extracorporeal-Life-Support-Systems (ECLSABSI). Device use was defined as the number device days per 100 patient days; device-associated infection rates as the number of device-associated infections per 1000 device days. To compare the pooled means between the years and quarters we calculated rate ratios of device-associated infection rates with 95% confidence intervals by Poisson regression models. RESULTS: The number of participating ICUs in the surveillance system decreased from 982 in 2019 to 921 in 2020 (6.2%). Device utilization rates increased significantly for central lines and ventilator use. VALRTI rates and CAUTI rates decreased in 2020 compared with 2019, however, no increase was shown for CLABSI or ECLSABSI. This result was also confirmed when the corresponding quarters per year were analyzed. CONCLUSIONS: The lack of an increase in device-associated healthcare associated infections (HAI) in German ICUs may be due to the lower overall incidence of COVID-19 cases in Germany in 2020 compared with US, to a very high availability of ICU beds per 100,000 inhabitants compared with many other countries, and a change in the ICU patient mix due to numerous elective procedures that were postponed during the first two waves. The primary reason seems to be that only 7% of all ICU patients in Germany in 2020 were COVID-19 patients.


Subject(s)
COVID-19 , Catheter-Related Infections , Cross Infection , Pneumonia, Ventilator-Associated , Sepsis , Urinary Tract Infections , COVID-19/epidemiology , Catheter-Related Infections/epidemiology , Cross Infection/epidemiology , Female , Humans , Intensive Care Units , Male , Pandemics , Pneumonia, Ventilator-Associated/epidemiology , Prospective Studies , Sepsis/epidemiology , Urinary Tract Infections/epidemiology
2.
J Pediatr Nurs ; 65: 29-32, 2022.
Article in English | MEDLINE | ID: covidwho-1796225

ABSTRACT

The failure of the global supply chain became rapidly apparent at the beginning of the COVID-19 pandemic when healthcare organizations were left without supplies needed to care for patients. The supply chain failure is one downstream effect of the pandemic and indirectly impacts patient morbidity and mortality. This column presents a case study of one staff nurse's experience working in a pediatric intensive care unit at a rural children's hospital two years into the pandemic and the toll the global supply chain failure continues to take on patients and healthcare professionals. Central Line Blood Stream Infections (CLABSIs) are used to showcase the severity of the supply chain failure at the point of care. Standardized central line insertion and care bundles have proven to be effective in reducing the incidence of CLABSI; however, they are dependent on the availability of materials and supplies. Health care providers face a "wicked problem" in preventing CLABSIs. The failure of the global supply chain must be examined by healthcare organizations, manufacturers, and government officials so that new systems can be put into place, so we are prepared for a public health emergency.


Subject(s)
COVID-19 , Catheter-Related Infections , Catheterization, Central Venous , Central Venous Catheters , Catheter-Related Infections/epidemiology , Catheter-Related Infections/prevention & control , Central Venous Catheters/adverse effects , Child , Humans , Pandemics/prevention & control
3.
Infect Dis Clin North Am ; 35(4): 841-856, 2021 12.
Article in English | MEDLINE | ID: covidwho-1506789

ABSTRACT

Despite a large volume of research in prevention, central line-associated bloodstream infections and catheter-related bloodstream infections continue to cause significant morbidity, mortality, and increased health care costs. Strategies in prevention, including decision about catheter placement, insertion bundles, adherence to standard of care guidelines, and technologic innovations, shown to decrease rates of catheter-related bloodstream infections and central line-associated bloodstream infections are described in this update. The coronavirus disease 2019 pandemic has resulted in increased health care-acquired infections, including central line-associated bloodstream infections.


Subject(s)
Bacteremia/prevention & control , Catheter-Related Infections/prevention & control , Catheterization, Central Venous/adverse effects , Bacteremia/epidemiology , Bacteremia/etiology , COVID-19/epidemiology , Catheter-Related Infections/epidemiology , Catheter-Related Infections/etiology , Catheterization, Central Venous/standards , Clinical Decision-Making , Cross Infection/epidemiology , Cross Infection/etiology , Humans , Patient Care Bundles/standards , Practice Guidelines as Topic , SARS-CoV-2
4.
J Hosp Infect ; 119: 149-154, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1458761

ABSTRACT

BACKGROUND: The incidence of nosocomial infections including ventilator-associated pneumonia and bacteraemia has been described during the COVID-19 pandemic. However, information regarding the impact of COVID-19 on the incidence of catheter-related bloodstream infections (CR-BSIs) is very limited. AIM: To evaluate the impact of the COVID-19 pandemic in the evolution of CR-BSIs in a large hospital. METHODS: This was a retrospective study comparing the incidence, aetiology and outcome of CR-BSIs during the months of March to May 2019 (pre-pandemic) and 2020 (during the pandemic). FINDINGS: The number of patients with one or more CR-BSIs in 2019 and 2020 were 23 and 58, respectively (1.89 vs 5.53/1000 admissions); P<0.001. Median time from catheter implantation to demonstration of CR-BSI was 27.5 days (range 11.75-126.00 days) in the 2019 cases and 16.0 days (range 11.00-23.50 days) in the 2020 population (P=0.032). CONCLUSIONS: A dramatic increase of CR-BSIs was found during the COVID-19 pandemic. Reinforcement of classic and new preventive measures is necessary.


Subject(s)
Bacteremia , COVID-19 , Catheter-Related Infections , Cross Infection , Bacteremia/epidemiology , Bacteremia/prevention & control , Catheter-Related Infections/epidemiology , Catheters , Cross Infection/epidemiology , Cross Infection/prevention & control , Humans , Pandemics , Retrospective Studies , SARS-CoV-2
5.
Infect Control Hosp Epidemiol ; 43(1): 12-25, 2022 01.
Article in English | MEDLINE | ID: covidwho-1392703

ABSTRACT

OBJECTIVES: To determine the impact of the coronavirus disease 2019 (COVID-19) pandemic on healthcare-associated infection (HAI) incidence in US hospitals, national- and state-level standardized infection ratios (SIRs) were calculated for each quarter in 2020 and compared to those from 2019. METHODS: Central-line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), ventilator-associated events (VAEs), select surgical site infections, and Clostridioides difficile and methicillin-resistant Staphylococcus aureus (MRSA) bacteremia laboratory-identified events reported to the National Healthcare Safety Network for 2019 and 2020 by acute-care hospitals were analyzed. SIRs were calculated for each HAI and quarter by dividing the number of reported infections by the number of predicted infections, calculated using 2015 national baseline data. Percentage changes between 2019 and 2020 SIRs were calculated. Supporting analyses, such as an assessment of device utilization in 2020 compared to 2019, were also performed. RESULTS: Significant increases in the national SIRs for CLABSI, CAUTI, VAE, and MRSA bacteremia were observed in 2020. Changes in the SIR varied by quarter and state. The largest increase was observed for CLABSI, and significant increases in VAE incidence and ventilator utilization were seen across all 4 quarters of 2020. CONCLUSIONS: This report provides a national view of the increases in HAI incidence in 2020. These data highlight the need to return to conventional infection prevention and control practices and build resiliency in these programs to withstand future pandemics.


Subject(s)
COVID-19 , Catheter-Related Infections , Cross Infection , Methicillin-Resistant Staphylococcus aureus , Pneumonia, Ventilator-Associated , Catheter-Related Infections/epidemiology , Cross Infection/epidemiology , Cross Infection/prevention & control , Delivery of Health Care , Humans , Pneumonia, Ventilator-Associated/epidemiology , Pneumonia, Ventilator-Associated/prevention & control , SARS-CoV-2
6.
Int Urol Nephrol ; 54(1): 193-199, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1270535

ABSTRACT

PURPOSE: Hemodialysis patients with COVID-19 are at increased risk of death. We aimed to describe the characteristics of a cohort of Brazilian hemodialysis patients with COVID-19 and assess their mortality rate and risk factors for death. METHODS: Retrospective cohort study of 741 Brazilian hemodialysis patients with confirmed COVID-19 from Feb-Dec/2020, of 52 dialysis centers of the country. We analyzed comorbid conditions, sociodemographic factors, and dialysis-related parameters. To detect risk factors for mortality in hemodialysis patients, we performed multivariable Cox proportional hazard regression analysis. Survival was analyzed by Kaplan-Meier. RESULTS: From 9877 hemodialysis patients, 741 were diagnosed with COVID-19. Mean age was 57 ± 16 years, 61% were male, and 51% white. The most frequent symptoms were fever (54.1%), cough (50.9%), and dyspnea (37.2%); 14.2% were asymptomatic. There were 139 deaths (18.8%), with 66% within the disease's first 15 days. 333 patients (44.9%) required hospitalization, and 211 (28.5%) were admitted to an intensive care unit. The cumulative probability of survival at 90 days of diagnosis was 79% (95% CI 76-82%). In the fully adjusted multivariate model, the risk factors significantly associated with death were diabetes mellitus (HR 1.52, 95% CI 1.05-2.19, P = 0.026), use of a central venous catheter (CVC) (HR 1.79, 95% CI 1.22-2.64, P = 0.003), age (HR 1.03, 95% CI 1.01-1.04, P < 0.001), and origin from the North vs. Southeast region (HR 2.60, 95% CI 1.01-6.68, P = 0.047). CONCLUSIONS: Hemodialysis patients using a CVC as the vascular access, aside from diabetic and elderly ones, should be closely monitored due to their high risk of death in the course of the COVID-19.


Subject(s)
COVID-19/epidemiology , Catheter-Related Infections/etiology , Central Venous Catheters/adverse effects , Kidney Failure, Chronic/therapy , Renal Dialysis/adverse effects , Brazil/epidemiology , Catheter-Related Infections/epidemiology , Comorbidity , Female , Follow-Up Studies , Humans , Incidence , Kidney Failure, Chronic/epidemiology , Male , Middle Aged , Retrospective Studies , SARS-CoV-2 , Survival Rate/trends , Time Factors
7.
Am J Infect Control ; 49(6): 843-845, 2021 06.
Article in English | MEDLINE | ID: covidwho-1269214

ABSTRACT

Several catheter-associated urinary tract infection (CAUTI) prevention interventions were successfully implemented and evaluated on a surgical unit in a community-based hospital. Sustainability of CAUTI prevention efforts requires daily communication between multidisciplinary staff. In our hospital, daily report on CAUTI events and indwelling catheters at a hospital-wide, multidisciplinary safety huddle contributed to an enhanced focus on CAUTI-prevention strategies and unit-level reduction in device use days and CAUTI rates.


Subject(s)
Catheter-Related Infections , Cross Infection , Urinary Tract Infections , Adult , Catheter-Related Infections/epidemiology , Catheter-Related Infections/prevention & control , Catheters, Indwelling/adverse effects , Cross Infection/epidemiology , Cross Infection/prevention & control , Hospitals , Humans , Urinary Catheterization/adverse effects , Urinary Tract Infections/prevention & control
8.
Am J Infect Control ; 49(6): 764-768, 2021 06.
Article in English | MEDLINE | ID: covidwho-1269209

ABSTRACT

BACKGROUND: Until recently, there has been a lack of viable alternative to an indwelling urinary catheter for female patients that require precise urine output measurements. With the introduction of external female urinary catheters, we can now substitute this type of device for an indwelling urinary catheter in many patients, decreasing their risk of catheter-associated urinary tract infections. METHODS: In this retrospective study, we analyzed the impact of a hospital-wide implementation of an external female urinary catheter at a large academic medical center. The study included female patients, greater than 18 years of age. We compared a 12-month period before and after device implementation to assess the impact on indwelling urinary catheter utilization and catheter-associated urinary tract infections rate. RESULTS: Data included over 220,000 patient days, over 10,000 external urinary catheter days and 33,000 indwelling urinary catheter days. We found a statistically significant decrease in indwelling urinary catheter utilization following the implementation of the external female urinary catheter, but only in intensive care units. CONCLUSIONS: It is our recommendation that facilities first implement the device in ICUs as this level of care was where we observed the most significant impact.


Subject(s)
Catheter-Related Infections , Cross Infection , Urinary Tract Infections , Catheter-Related Infections/epidemiology , Catheter-Related Infections/prevention & control , Catheters, Indwelling/adverse effects , Female , Humans , Retrospective Studies , Urinary Catheterization/adverse effects , Urinary Catheters/adverse effects , Urinary Tract Infections/prevention & control
9.
Antimicrob Resist Infect Control ; 10(1): 87, 2021 06 04.
Article in English | MEDLINE | ID: covidwho-1259218

ABSTRACT

BACKGROUND: During the intensive care units' (ICUs) reorganization that was forced by the COVID-19 emergency, attention to traditional infection control measures may have been reduced. Nevertheless, evidence on the effect of the COVID-19 pandemic on healthcare-associated infections (HAIs) is still limited and mixed. In this study, we estimated the pandemic impact on HAI incidence and investigated the HAI type occurring in COVID-19 patients. METHODS: Patients admitted to the main ICU of the Umberto I teaching hospital of Rome from March 1st and April 4th 2020 were compared with patients hospitalized in 2019. We assessed the association of risk factors and time-to-first event through multivariable Fine and Grey's regression models, that consider the competitive risk of death on the development of HAI (Model 1) or device related-HAI (dr-HAI, Model 2) and provide estimates of the sub-distribution hazard ratio (SHR) and its associated confidence interval (CI). A subgroup analysis was performed on the 2020 cohort. RESULTS: Data from 104 patients were retrieved. Overall, 59 HAIs were recorded, 32 of which occurred in the COVID-19 group. Patients admitted in 2020 were found to be positively associated with both HAI and dr-HAI onset (SHR: 2.66, 95% CI 1.31-5.38, and SHR: 10.0, 95% CI 1.84-54.41, respectively). Despite being not confirmed at the multivariable analysis, a greater proportion of dr-HAIs seemed to occur in COVID-19 patients, especially ventilator-associated pneumonia, and catheter-related urinary tract infections. CONCLUSIONS: We observed an increase in the incidence of patients with HAIs, especially dr-HAIs, mainly sustained by COVID-19 patients. A greater susceptibility of these patients to device-related infections was hypothesized, but further studies are needed.


Subject(s)
COVID-19/epidemiology , Cross Infection/epidemiology , Intensive Care Units/statistics & numerical data , Aged , Catheter-Related Infections/epidemiology , Critical Care , Delivery of Health Care , Female , Hospitalization , Hospitals, Teaching , Humans , Incidence , Infection Control , Male , Middle Aged , Pandemics , Pneumonia, Ventilator-Associated/epidemiology , Retrospective Studies , Risk Factors , SARS-CoV-2/isolation & purification
10.
Infect Control Hosp Epidemiol ; 43(1): 26-31, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1146282

ABSTRACT

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had a considerable impact on US hospitalizations, affecting processes and patient population. OBJECTIVE: To evaluate the impact of COVID-19 pandemic on central-line-associated bloodstream infections (CLABSIs) and catheter associated urinary tract infections (CAUTIs) in hospitals. METHODS: We performed a retrospective study of CLABSIs and CAUTIs in 78 US 12 months before COVID-19 and 6 months during COVID-19 pandemic. RESULTS: During the 2 study periods, there were 795,022 central-line days and 817,267 urinary catheter days. Compared to the period before the COVID-19 pandemic, CLABSI rates increased by 51.0% during the pandemic period from 0.56 to 0.85 per 1,000 line days (P < .001) and by 62.9% from 1.00 to 1.64 per 10,000 patient days (P < .001). Hospitals with monthly COVID-19 patients representing >10% of admissions had a National Health Safety Network (NHSN) device standardized infection ratio for CLABSI that was 2.38 times higher than hospitals with <5% prevalence during the pandemic period (P = .004). Coagulase-negative Staphylococcus CLABSIs increased by 130% from 0.07 to 0.17 events per 1,000 line days (P < .001), and Candida spp by 56.9% from 0.14 to 0.21 per 1,000 line days (P = .01). In contrast, no significant changes were identified for CAUTI (0.86 vs 0.77 per 1,000 catheter days; P = .19). CONCLUSIONS: The COVID-19 pandemic was associated with substantial increases in CLABSIs but not CAUTIs. Our findings underscore the importance of hardwiring processes for optimal line care and regular feedback on performance to maintain a safe environment.


Subject(s)
COVID-19 , Catheter-Related Infections , Cross Infection , Sepsis , Urinary Tract Infections , Catheter-Related Infections/epidemiology , Catheter-Related Infections/prevention & control , Cross Infection/epidemiology , Cross Infection/prevention & control , Humans , Intensive Care Units , Pandemics , Retrospective Studies , SARS-CoV-2 , Sepsis/epidemiology , Urinary Catheters , Urinary Tract Infections/epidemiology , Urinary Tract Infections/prevention & control
11.
Am J Infect Control ; 49(8): 1075-1077, 2021 08.
Article in English | MEDLINE | ID: covidwho-1086738

ABSTRACT

This case study is part of a series centered on the Centers for Disease Control and Prevention/National Healthcare Safety Network (NHSN) healthcare-associated infection (HAI) surveillance definitions. This specific case study focuses on the application of the Pneumonia (PNEU), Ventilator-associated event (VAE), and Bloodstream infections (BSI) surveillance definitions to a patient with COVID-19. The intent of the case study series is to foster standardized application of the NHSN HAI surveillance definitions among Infection Preventionists (IPs) and encourage accurate determination of HAI events.


Subject(s)
COVID-19 , Catheter-Related Infections , Cross Infection , Pneumonia, Ventilator-Associated , Catheter-Related Infections/epidemiology , Catheter-Related Infections/prevention & control , Cross Infection/epidemiology , Cross Infection/prevention & control , Data Accuracy , Delivery of Health Care , Humans , Infection Control , Pneumonia, Ventilator-Associated/epidemiology , Pneumonia, Ventilator-Associated/prevention & control , SARS-CoV-2 , United States
13.
J Nephrol ; 34(2): 345-353, 2021 04.
Article in English | MEDLINE | ID: covidwho-996505

ABSTRACT

BACKGROUND: In hemodialysis (HD) patients, central venous catheter (CVC) related bloodstream infections are a major cause of morbidity and mortality. Hygienic precautions are a key aspect of dialysis care for infection prevention, but they are not sufficient to completely avoid the occurrence of CVC related infections. During the COVID-19 pandemic, hygienic precautions for preventing viral transmission have been markedly reinforced. We evaluated their effects on CVC-related infection rates. METHODS: An observational retrospective study was conducted in two hemodialysis units of the same institution treating 215 chronic hemodialysis patients, 71 of whom are currently (33%) using a CVC. In the CVC cohort, we compared data on catheter-related infection rates during the maximum spread of the COVID-19 pandemic in Italy (February to May 2020) with data from the same period of the previous year and with the whole of 2019. RESULTS: In 2019, we recorded a catheter-related bloodstream infection (CRBSI) rate of 1.19 (95% CI 0.81-1.68)/1000 days [2.07 (95% CI 1.12-3.52)/1000 days in the Feb-May 2019 period] and a tunnel and exit-site infection rate of 0.82 (95% CI 0.51-1.24)/1000 days [1.04 (95% CI 0.41-2.15)/1000 days in the Feb-May 2019 period]. Infection rates drastically decreased during the COVID-19 pandemic, with just one catheter-related bloodstream infection being recorded. Catheter-related bloodstream infection rates showed a significant reduction to 0.20 (95% CI 0.01-0.9)/1000 days (p < 0.05 and p < 0.005 compared to 2019 and to Feb-May 2019, respectively) and a non-significant reduction in tunnel and exit-site infections to 0.6 (95% CI 0.15-1.6)/1000 days. CONCLUSIONS: The observed 91% reduction in catheter-related bloodstream infections compared to the same period in 2019 [IRR 0.09 (95% CI 0.002-0.64)] and the 83% reduction compared to the whole of 2019 [IRR 0.17 (95% CI 0.004-1.009)] suggest that a stricter implementation of hygienic precautions in the dialysis setting can markedly improve the problem of CVC-related infections.


Subject(s)
COVID-19/prevention & control , Catheter-Related Infections/prevention & control , Central Venous Catheters/adverse effects , Pandemics , Renal Dialysis/adverse effects , Aged , COVID-19/epidemiology , Catheter-Related Infections/epidemiology , Comorbidity , Female , Humans , Incidence , Italy/epidemiology , Kidney Failure, Chronic/epidemiology , Kidney Failure, Chronic/therapy , Male , Retrospective Studies , SARS-CoV-2
14.
J Pediatr Surg ; 55(7): 1339-1343, 2020 Jul.
Article in English | MEDLINE | ID: covidwho-997195

ABSTRACT

BACKGROUND: The infectious risk of central venous line (CVL) placement in children with neutropenia (absolute neutrophil count [ANC] <500/mm3) is not well defined. This study aims to investigate the early (≤30 days) and late (>30 days) infectious complications of CVLs placed in pediatric patients with and without neutropenia. METHODS: A retrospective review was conducted of all CVLs placed by pediatric surgeons at two institutions from 2010 to 2017. Multivariable logistic regression was performed to identify risk factors for line infection. Propensity score-matched cohorts of patients with and without neutropenia were compared in a 1:1 ratio. Wilcoxon rank-sum, Chi-square, Fisher's exact, and log-rank tests were also performed. RESULTS: Review identified 1,102 CVLs placed in 937 patients. Fifty-four patients were neutropenic at the time of placement. Multivariable analysis demonstrated tunneled catheters and subclavian access as associated with line infection. The propensity score-matched cohort included 94 patients, 47 from each group. Demographic and preoperative data were similar between the groups (p > 0.05). Patients with neutropenia were no more likely to develop early (4.3% vs. 2.1%, p = 1.000) or late (19.1% vs. 17.0%, p = 1.000) infectious complications than patients without neutropenia, with similar median time to infection (141 vs. 222 days, p = 0.370). CONCLUSION: A policy of selective CVL placement in neutropenic patients with standardized postoperative line maintenance is safe. Future directions include defining criteria by which neutropenic patients could be prospectively selected for safe CVL placement. LEVEL OF EVIDENCE: II - Retrospective cohort study.


Subject(s)
Catheter-Related Infections/epidemiology , Catheterization, Central Venous/adverse effects , Neutropenia/epidemiology , Postoperative Complications/epidemiology , Child , Humans , Perioperative Period , Propensity Score , Retrospective Studies , Risk Factors
15.
JAMA ; 324(13): 1307-1316, 2020 10 06.
Article in English | MEDLINE | ID: covidwho-739602

ABSTRACT

Importance: Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients. Objective: To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS. Design, Setting, and Participants: Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients. Interventions: Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148). Main Outcomes and Measures: The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days. Results: A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events. Conclusions and Relevance: Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days. Trial Registration: ClinicalTrials.gov Identifier: NCT04327401.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Coronavirus Infections/drug therapy , Dexamethasone/therapeutic use , Pneumonia, Viral/drug therapy , Respiration, Artificial/statistics & numerical data , Respiratory Distress Syndrome/drug therapy , Administration, Intravenous , Aged , Anti-Inflammatory Agents/adverse effects , Betacoronavirus , Brazil , COVID-19 , Catheter-Related Infections/epidemiology , Coronavirus Infections/complications , Coronavirus Infections/mortality , Coronavirus Infections/therapy , Dexamethasone/adverse effects , Early Termination of Clinical Trials , Female , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/mortality , Pneumonia, Viral/therapy , Respiratory Distress Syndrome/etiology , SARS-CoV-2
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