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1.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-307820

ABSTRACT

Background: Hyponatremia has been described in severe acute respiratory syndrome. Our objective was to describe the impact of hyponatremia on COVID-19 patients’ outcome (intensive care unit [ICU] admission, mechanic ventilation or death). Methods According to natremia at admission, two groups were retrospectively screened: hyponatremic (< 135 mM, n = 101) or normonatremic (natremia ≥ 135 mM, n = 222) patients. Pearson’s chi-2 (qualitative variables) and Student tests (quantitative variables) were used to compare the two groups. A multiple logistic regression model was used to assess the association of outcome and patients’ data. Results Hyponatremia was generally mild. There were more male patients in the hyponatremic group (p = 0.005). Pulmonary lesions on the first thoracic CT-scanner performed during the hospitalization were significantly more extended in the hyponatremic group (p = 0.03). ICU admission, mechanic ventilation or death were significantly higher in hyponatremic compared to normonatremic patients (34 versus 14%;p < 0.001;16% versus 5%;p = 0.002;19 versus 9%, p = 0.021, respectively). Hyponatremia was an independent predictor of poor outcome (adjusted Odds-ratio: 2.49 [1.18–5.33, p = 0.017]). Conclusions Our study showed an independent relationship between hyponatremia at admission and transfer to ICU, use of mechanic ventilation or death in COVID-19. Hyponatremia may reflect the potential severity of underlying pulmonary lesions. Our results support the use of natremia as a simple bedside screening tool for early identification of SARS-CoV-2 infected patients at high risk of poor outcome.

2.
Lancet Respir Med ; 10(2): 180-190, 2022 02.
Article in English | MEDLINE | ID: covidwho-1537209

ABSTRACT

BACKGROUND: Patients with severe COVID-19 have emerged as a population at high risk of invasive fungal infections (IFIs). However, to our knowledge, the prevalence of IFIs has not yet been assessed in large populations of mechanically ventilated patients. We aimed to identify the prevalence, risk factors, and mortality associated with IFIs in mechanically ventilated patients with COVID-19 under intensive care. METHODS: We performed a national, multicentre, observational cohort study in 18 French intensive care units (ICUs). We retrospectively and prospectively enrolled adult patients (aged ≥18 years) with RT-PCR-confirmed SARS-CoV-2 infection and requiring mechanical ventilation for acute respiratory distress syndrome, with all demographic and clinical and biological follow-up data anonymised and collected from electronic case report forms. Patients were systematically screened for respiratory fungal microorganisms once or twice a week during the period of mechanical ventilation up to ICU discharge. The primary outcome was the prevalence of IFIs in all eligible participants with a minimum of three microbiological samples screened during ICU admission, with proven or probable (pr/pb) COVID-19-associated pulmonary aspergillosis (CAPA) classified according to the recent ECMM/ISHAM definitions. Secondary outcomes were risk factors of pr/pb CAPA, ICU mortality between the pr/pb CAPA and non-pr/pb CAPA groups, and associations of pr/pb CAPA and related variables with ICU mortality, identified by regression models. The MYCOVID study is registered with ClinicalTrials.gov, NCT04368221. FINDINGS: Between Feb 29 and July 9, 2020, we enrolled 565 mechanically ventilated patients with COVID-19. 509 patients with at least three screening samples were analysed (mean age 59·4 years [SD 12·5], 400 [79%] men). 128 (25%) patients had 138 episodes of pr/pb or possible IFIs. 76 (15%) patients fulfilled the criteria for pr/pb CAPA. According to multivariate analysis, age older than 62 years (odds ratio [OR] 2·34 [95% CI 1·39-3·92], p=0·0013), treatment with dexamethasone and anti-IL-6 (OR 2·71 [1·12-6·56], p=0·027), and long duration of mechanical ventilation (>14 days; OR 2·16 [1·14-4·09], p=0·019) were independently associated with pr/pb CAPA. 38 (7%) patients had one or more other pr/pb IFIs: 32 (6%) had candidaemia, six (1%) had invasive mucormycosis, and one (<1%) had invasive fusariosis. Multivariate analysis of associations with death, adjusted for candidaemia, for the 509 patients identified three significant factors: age older than 62 years (hazard ratio [HR] 1·71 [95% CI 1·26-2·32], p=0·0005), solid organ transplantation (HR 2·46 [1·53-3·95], p=0·0002), and pr/pb CAPA (HR 1·45 [95% CI 1·03-2·03], p=0·033). At time of ICU discharge, survival curves showed that overall ICU mortality was significantly higher in patients with pr/pb CAPA than in those without, at 61·8% (95% CI 50·0-72·8) versus 32·1% (27·7-36·7; p<0·0001). INTERPRETATION: This study shows the high prevalence of invasive pulmonary aspergillosis and candidaemia and high mortality associated with pr/pb CAPA in mechanically ventilated patients with COVID-19. These findings highlight the need for active surveillance of fungal pathogens in patients with severe COVID-19. FUNDING: Pfizer.


Subject(s)
COVID-19 , Pulmonary Aspergillosis , Adolescent , Adult , Child, Preschool , Humans , Intensive Care Units , Male , Middle Aged , Respiration, Artificial , Retrospective Studies , SARS-CoV-2
4.
J Nephrol ; 34(4): 991-998, 2021 08.
Article in English | MEDLINE | ID: covidwho-1171147

ABSTRACT

AIM: Our objective was to describe the impact of hyponatremia on the outcomes of COVID-19 patients [outcomes selected: intensive care unit (ICU) admission, mechanical ventilation or death]. METHODS: Two groups of COVID-19 patients were retrospectively screened on the basis of plasma sodium level at admission: hyponatremic (sodium < 135 mM, n = 92) or normonatremic (sodium ≥ 135 mM, n = 198) patients. Pearson's chi-2 (qualitative variables) and Student's T tests (quantitative variables) were used to compare the two groups. A multiple logistic regression model was used to explore the association between patients' clinical data and outcomes. RESULTS: Hyponatremia was frequent but generally mild. There were more male patients in the hyponatremic group (p = 0.014). Pulmonary lesions on the first thoracic CT-scan performed during hospitalization were significantly more extensive in the hyponatremic group (p = 0.010). ICU admission, mechanical ventilation or death were significantly more frequent in hyponatremic compared to normonatremic patients (37 versus 14%; p < 0.001; 17 versus 6%; p = 0.003; 18 versus 9%, p = 0.042, respectively). Hyponatremia was an independent predictor of adverse outcomes (adjusted Odds-ratio: 2.77 [1.26-6.15, p = 0.011]). CONCLUSIONS: Our study showed an independent relationship between hyponatremia at admission and transfer to ICU, use of mechanical ventilation or death in COVID-19 patients. Hyponatremia may reflect the severity of underlying pulmonary lesions. Our results support the use of sodium levels as a simple bedside screening tool for the early identification of SARS-CoV-2 infected patients at high risk of poor outcome.


Subject(s)
COVID-19 , Hyponatremia , Female , Humans , Hyponatremia/diagnosis , Hyponatremia/epidemiology , Male , Retrospective Studies , SARS-CoV-2 , Sodium
5.
Crit Care Med ; 49(1): e11-e19, 2021 01 01.
Article in English | MEDLINE | ID: covidwho-910342

ABSTRACT

OBJECTIVES: Many trials investigate potential effects of treatments for coronavirus disease 2019. To provide sufficient information for all involveddecision-makers (clinicians, public health authorities, and drug regulatory agencies), a multiplicity of endpoints must be considered. The objectives are to provide hands-on statistical guidelines for harmonizing heterogeneous endpoints in coronavirus disease 2019 clinical trials. DESIGN: Randomized controlled trials for patients infected with coronavirus disease 2019. SETTING: General methods that apply to any randomized controlled trial for patients infected with coronavirus disease 2019. PATIENTS: Coronavirus disease 2019 positive individuals. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We develop a multistate model that is based on hospitalization, mechanical ventilation, death, and discharge. These events are both categories of the ordinal endpoint recommended by the World Health Organization and also within the core outcome set of the Core Outcome Measures in Effectiveness Trials initiative for coronavirus disease 2019 trials. To support our choice of states in the multistate model, we also perform a brief review of registered coronavirus disease 2019 clinical trials. Based on the multistate model, we give recommendation for compact, informative illustration of time-dynamic treatment effects and explorative statistical analysis. A majority of coronavirus disease 2019 clinical trials collect information on mechanical ventilation, hospitalization, and death. Using reconstructed and real data of coronavirus disease 2019 trials, we show how a stacked probability plot provides a detailed understanding of treatment effects on the patients' course of hospital stay. It contributes to harmonizing multiple endpoints and differing lengths of follow-up both within and between trials. CONCLUSIONS: All ongoing clinical trials should include a stacked probability plot in their statistical analysis plan as descriptive analysis. While primary analysis should be on an early endpoint with appropriate capability to be a surrogate (parameter), our multistate model provides additional detailed descriptive information and links results within and between coronavirus disease 2019 trials.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Pandemics/prevention & control , Randomized Controlled Trials as Topic/methods , COVID-19/prevention & control , Endpoint Determination , Humans , Research Design
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