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Introduction: Critically ill patients with severe COVID-19 have an increased risk of bacterial and fungal superinfections due to a dysregulated immune response characterized by lymphopenia and low immunoglobulins levels. The intravenous immunoglobulins are involved in pathogen/toxin scavenging and inhibition of inflammatory mediators gene transcription with anti-apoptotic effects on immune system cells. This research aimed to describe the effects of intravenous IgM-enriched immunoglobulins in COVID-19 patients with sepsis due to secondary infections and low IgM levels. Method(s): We performed an observational retrospective study, including patients admitted to our intensive care unit (ICU) between March 2020 and February 2021 with severe COVID-19 and sepsis due to a superinfection (known or suspected) treated with intravenous IgM-enriched immunoglobulins. We collected demographic data and comorbidities. We noted hemodinamic data, antimicrobial and adiuvant therapies, laboratory results at ICU admission (T0), at the beginning (T1) and at the end (T2) of the IgM-enriched immunoglobulins infusion and at ICU discharge (T3). Result(s): In our cohort of 36 patients (Table 1) the prevalence of documented secondary infections was 83%. We observed a significant reduction of leukocytes from T0 to T3 (10.4 [8.3-14.5] x 103/ mmc vs 7.1 [4.8-11.2] x 103/ mmc, p < 0.01) and the SOFA score from T0 to T2 (7 [6-19] vs 5 [3-7], p < 0.01) and from T0 to T3 (7 [6-10] vs 4 [2-9], p < 0.01);from T1 to T2 (7 [6-9] vs 5 [3-7], p < 0.01) and from T1 to T3 (7 [6-9] vs 4 [2-9], p < 0.01). Cardiovascular SOFA showed a statistically significant reduction from T1 to T2 (4 [3-4] vs 0 [0-3], p < 0.01). Conclusion(s): The IgM-enriched immunoglobulins could improve organ function, as evidenced by the reduction of the SOFA score. Although the latest Surviving Sepsis Campaign guidelines suggest against using of IgM-enriched immunoglobulins, our study supports its use as an adjunctive therapy in COVID-19 patients with septic shock.
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Introduction: Venovenous extracorporeal membrane oxygenation (VV ECMO) is a technique that provides blood oxygenation and CO2 removal, allowing a protective ventilation strategy until the resolution of respiratory failure. A delay in ECMO initiation could worsen the outcome and prolong the duration of treatment. The study aims to describe the incidence of mortality in our intensive care unit (ICU) in patients with severe COVID-19-related acute respiratory distress syndrome (ARDS) treated with VV ECMO. Method(s): We performed an observational retrospective study, including patients with severe COVID-19-related ARDS admitted to our ICU and treated with VV ECMO between February 2020 and February 2022. We collected data on demographic characteristics, comorbidities, mechanical ventilation, therapies, laboratory results, VV ECMO and ICU mortality. SOFA score, SAPS II and Charlson Comorbidity Index were calculated at ICU admission. Result(s): The average age of our cohort of 60 patients was 54.4 +/- 7.7 years and 51 (85%) were males. The mean value of the SOFA score at ICU admission was 7 +/- 2.3 points, and the median value of the SAPS II score was 41 [31-48] points. The incidence of mortality in the whole cohort was 48.3%. The differences between the two groups of patients, Survivors and Non-survivors, are presented in Table 1. Through a multivariate logistic regression model we found that age (OR 1.09 [95% CI 1.00-1.19], p = 0.03) and lymphocytes (OR 0.09 [95% CI 0.01-0.59], p = 0.01) were significantly associated with ICU mortality. Mechanical ventilation before ECMO placement higher than 10 days and superinfections at ICU admission were not significantly associated with the outcome in the same model. Conclusion(s): In patients with COVID-19-related ARDS treated with VV ECMO, advanced age and lymphopenia at ICU admission are risk factors for ICU mortality. A longer duration of mechanical ventilation before ECMO placement and traditional ICU prognostic scores seem not to be relevant for the prognosis.
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Introduction: The clinical features and acute complications of patients with severe COVID-19 have long been described. However, little information is available about the quality of life and long-term persistent symptoms after discharge from ICU [1]. The purpose of this study is to describe the symptoms, the neurological, functional and psychological status 6 months after discharge from ICU. Methods: We performed an observational prospective monocentric study. We considered patients admitted to ICU for acute respiratory failure from SARS-CoV-2 infection from March 2020 to March 2021 and discharged alive. Patients underwent a telephone interview 6 months after discharge. We asked for residual symptoms. Neurological, psychological and functional status was assessed using validated questionnaires. Results: Of the 111 eligible patients, 6 (5.4%) died after discharge and 35 (31,5%) were lost to follow-up. Demographic characteristics of the population are presented in Table 1. At 6 months after discharge, 9 (12.8%) patients reported no symptoms. Dyspnoea was present in 45 (64.3%) patients, asthenia in 39 (55.7%). 32 patients (45.7%) reported memory deficit, 28 (40%) peripheral neuropathy, 17 (24.3%) artrhalgias and 6 (8.6%) dysphagia. Palpitations were present in 16 (22.8%) patients and 10 (14.3%) patients experienced insomnia or agitation. The PC-PTSD-5 was positive in 21 (30%) patients. Based on PCFS Scale, 13 (18.6%) patients reported no functional limitations, 14 (20%) negligible functional limitations, 24 (34.3%) slight functional limitations, 5 (7.1%) moderate functional limitations and 14 (20%) severe functional limitations. The GOS-E score was 6 [5-8] and it was inversely correlated with the number of hypoxia episodes (Spearman rho = - 0.25, CI 95% - 0.47 to - 0.01, p = 0.03). Conclusions: At 6 months after ICU discharge, only a few patients reported no symptoms or functional limitations. Dyspnoea, asthenia and neurological symptoms were the most frequently described. (Table Presented).
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Introduction: Even if life-saving in most cases, excess O2 may have adverse effects. We described the prevalence of hyperoxemia and excess O2 administration in patients with severe acute respiratory syndrome due to novel coronavirus (SARS-CoV-2) and explored the association with mortality in the intensive care unit (ICU) or ventilatorassociated pneumonia (VAP). Methods: Retrospective single-centre study on 134 patients with SARS-CoV-2 requiring mechanical ventilation for ≥ 48 h. We calculated the excess O2 administered based on an ideal arterial O2 tension ( PaO2) target of 55-80 mmHg. We defined hyperoxemia as PaO2 > 100 mmHg and hyperoxia + hyperoxemia as an inspired O2 fraction (FiO2) > 60% + PaO2 > 100 mmHg. Risk factors for ICU-mortality and VAP were assessed with multivariate analyses. Results: Each patient received an excess O2 of 1121 [829-1449] l per day of mechanical ventilation. Hyperoxemia was found in 38 [27-55] % of arterial blood gases, hyperoxia + hyperoxemia in 11 [5-18] %. The FiO2 was not reduced in 69 [62-76] % of cases of hyperoxemia. Adjustments were more frequent with higher PaO2 or initial FiO2 levels. ICU-mortality was 32%. VAP was diagnosed in 48.5% of patients. Hyperoxemia (odds ratio [OR] 1.300 95% confidence interval [1.097- 1.542]) and hyperoxia + hyperoxemia (OR 1.144 [1.008-1.298]) were associated with higher risk for ICU-mortality, independently of age, Sequential Organ failure Assessment score at ICU-admission and mean PaO2/FiO2. Hyperoxemia (OR 1.033 [1.006-1.061]), hyperoxia + hyperoxemia (OR 1.038 [1.003-1.075]) and daily excess O2 (OR 1.001 [1.000- 1.001]) were identified as risk factors for VAP, independently of body mass index, blood transfusions, days of neuromuscular blocking agents before VAP, prolonged prone positioning and mean PaO2/FiO2 before VAP. Conclusions: Excess O2 administration and hyperoxemia were common in mechanically ventilated patients with SARS-CoV-2 and may be associated with ICU-mortality and greater risk for VAP.
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Introduction: Patients with severe COVID-19 admitted to ICU have an increased risk of bacterial and fungal superinfections [1,2]. Steroid therapy with dexamethasone is one of the recommended treatments for patients on oxygen therapy. The aim of this study is to evaluate the incidence of superinfections in patients treated with steroids. Methods: We performed an observational retrospective study, including patients with severe COVID-19 admitted to our ICU between March 2020 and February 2021. Data on bacterial and fungal superinfections and steroid therapy were collected. Results: Among the 152 patients enrolled, 82 (53.9%) received steroid therapy before admission to ICU, 50 (32.9%) did not receive steroids, for 20 (13.2%) the steroid treatment was not known. The clinical characteristics of the two groups of patients at admission are presented in Table 1. Comparing patients receiving steroids and those not receiving steroids, the incidence of superinfections due to fungi was respectively 29.6% vs 12.2% (RR 2.41, CI 95%: 1.06-5.50). The incidence of Gram- and Gram + superinfections was respectively 56% vs 55% (RR 1.03, CI 95%: 0.75-1.41) and 54% vs 38% (RR 1.40, CI 95% 0.93-2.09). Among Gram- superinfections, we observed a significant association between steroid therapy and Acinetobacter spp. superinfection (19.7% in patients on steroids and 6.1% in patients who did not receive steroids, p = 0.03). The duration of steroid therapy was directly correlated with the number of superinfections for each patient (Spearman's rho = 0.34, CI 95% 0.18-0.48, p < 0.001). Conclusions: In patients with severe COVID-19 admitted to ICU, steroid therapy seems to be a risk factor for fungal superinfections and associated with Acinetobacter spp. superinfections. The duration of the steroid therapy is directly correlated to the number of superinfections for each patient. (Table Presented).
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Background: During Coronavirus Disease-19 (COVID-19) pandemic, the way to guarantee the adherence to treatment for patients with lysosomal disorders (LDs) in Italy, was home therapy, allowed by the temporary and exceptional authorization 341/2020 of the Italian Medicines Agency (AIFA). Stable patients affected with Pompe disease and mucopolysaccharidosis type I (MPS I) could then receive regular enzyme replacement therapy (ERT) infusions at home. Indeed, a data collection was considered a good occasion to investigate the safety of home infusions considering that information is still lacking. Methods: This is an Italian, multicenter, non-interventional, double cohort study sponsored by Sanofi Genzyme with both retrospective and prospective data collection to obtain safety information on ERT treatment of Pompe disease and mucopolysaccharidosis type I (MPS I) patients in a home-care setting. The study will enroll 60 patients at 15 sites. The retrospective observation will start from the first ERT infusions in a homecare setting and the prospective observation will last after 12 months from the enrollment. During the control visits, investigators will administer the questionnaires and will record any documented clinical data occurred during the home infusions. Objectives: This study aims at obtaining safety information on patients with Pompe disease treated with alglucosidase alfa and of patients with MPS I treated with laronidase in a home-care setting, as well as evaluating personal satisfaction of both cohorts of patients and documenting infusion compliance. Conclusions: The outcomes will mirror real-life management of patients in home-care infusion setting, including safety profile, treatment compliance and quality of life.
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The coronavirus 19 (COVID-19) pandemic has affected hundreds of millions of people worldwide: in most of cases children and young people developed asymptomatic or pauci-symptomatic clinical pictures. However authors have showed that there are some categories of childhood more vulnerable to COVID-19 infection such as newborns or children with comorbidities. We report for the first time to the best of our knowledge about microvascular dysfunction in three pediatric clinical cases who developed COVID-19 infections with need of pediatric critical care. We found that sublingual microcirculation is altered in children with severe COVID-19 infection. Our findings confirmed most of data already observed by other authors in adult population affected by severe COVID-19 infection, but with distinct characteristics than microcirculation alterations previous observed in a clinical case of MIS-C. However we cannot establish direct correlation between microcirculation analysis and clinical or laboratory parameters in our series, by our experience we have found that sublingual microcirculation analysis allow clinicians to report directly about microcirculation dysfunction in COVID-19 patients and it could be a valuable bedside technique to monitor thrombosis complication in this population.
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BACKGROUND: Published reports on tocilizumab in COVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues. METHODS: This open-label trial, structured according to Simon's optimal design, aims to identify factors predicting which patients could benefit from anti-IL6 strategies and to enhance the design of unequivocal and reliable future randomized trials. A total of 46 patients with COVID-19 pneumonia needing of oxygen therapy to maintain SO2 > 93% and with recent worsening of lung function received a single infusion of tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary end point was early and sustained clinical response. RESULTS: Twenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher baseline values of PaO2/FiO2 (P = 0.008) predicted a favourable response. CONCLUSIONS: Objective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function in patients selected according to our inclusion criteria warrants investigations in randomized trials.
Subject(s)
Antibodies, Monoclonal, Humanized , Biomarkers, Pharmacological/analysis , COVID-19 , Drug Monitoring/methods , Interleukin-6 , Pneumonia, Viral , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/pharmacokinetics , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/physiopathology , COVID-19/therapy , Female , Humans , Immunologic Factors/administration & dosage , Immunologic Factors/pharmacokinetics , Infusions, Intravenous , Interleukin-6/antagonists & inhibitors , Interleukin-6/blood , Italy/epidemiology , Male , Oximetry/methods , Oxygen Inhalation Therapy/methods , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Pneumonia, Viral/etiology , Predictive Value of Tests , Respiratory Function Tests/methods , SARS-CoV-2/isolation & purification , Treatment OutcomeABSTRACT
Novel coronavirus 2019 is a single-stranded, ribonucleic acid virus that has led to an international pandemic of coronavirus disease 2019. Clinical data from the Chinese outbreak have been reported, but experiences and recommendations from clinical practice during the Italian outbreak have not. We report the impact of the coronavirus disease 2019 outbreak on regional and national healthcare infrastructure. We also report on recommendations based on clinical experiences of managing patients throughout Italy. In particular, we describe key elements of clinical management, including: safe oxygen therapy; airway management; personal protective equipment; and non-technical aspects of caring for patients diagnosed with coronavirus disease 2019. Only through planning, training and team working will clinicians and healthcare systems be best placed to deal with the many complex implications of this new pandemic.