BACKGROUND: Dexamethasone 6 mg in patients with severe COVID-19 has been shown to decrease mortality and morbidity. The effects of higher doses of corticosteroid, that would further increase anti-inflammatory effects, are uncertain. The objective of our study was to assess the effect of 20 mg dexamethasone vs. 6 mg dexamethasone intravenously in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) and COVID-19. METHODS: In a multicenter, open-label, randomized trial conducted in nine hospitals in the Czech Republic, we randomized adult patients with ARDS and COVID-19 requiring high-flow oxygen, noninvasive or invasive mechanical ventilation to receive either intravenous high-dose dexamethasone (20 mg/day on days 1-5, 10 mg/day on days 6-10) or standard-dose dexamethasone (6 mg/d, days 1-10). The primary outcome was 28-day ventilator-free days. The five secondary outcomes were 60-day mortality, C-reactive protein dynamics, 14-day WHO (World Health Organization) Clinical Progression Scale score, adverse events and 90-day Barthel index. The long-term outcomes were 180- and 360-day mortality and the Barthel index. The planned sample size was 300, with interim analysis after enrollment of 150 patients. RESULTS: The trial was stopped due to a lack of recruitment, and the follow-up was completed in February 2023. Among 234 randomized patients of 300 planned patients, the primary outcome was available for 224 patients (110 high-dose and 114 standard-dose dexamethasone; median [interquartile range (IQR)] age, 59.0 [48.5-66.0] years; 130 [58.0%] were receiving noninvasive or invasive mechanical ventilation at baseline). The mean number of 28-day ventilator-free days was 8.9 (± 11.5) days for high-dose dexamethasone and 8.0 (± 10.7) days for standard-dose dexamethasone, with an absolute difference of + 0.81 days (95% CI - 2.12-3.73 days). None of the prespecified secondary outcomes, including adverse events, differed between the groups. CONCLUSIONS: Despite not reaching its prespecified enrollment, there was no signal to either benefit or harm high-dose dexamethasone over standard-dose dexamethasone in patients with COVID-19 and moderate-to-severe ARDS. Trial registration Trial registration: ClinicalTrials.gov Identifier: NCT04663555. Registered 10 December 2020, https://clinicaltrials.gov/study/NCT04663555?term=NCT04663555&rank=1 and EudraCT: 2020-005887-70.
- MeSH
- COVID-19 * mortalita komplikace MeSH
- dexamethason * aplikace a dávkování terapeutické užití MeSH
- farmakoterapie COVID-19 * MeSH
- lidé středního věku MeSH
- lidé MeSH
- SARS-CoV-2 MeSH
- senioři MeSH
- syndrom dechové tísně * farmakoterapie mortalita MeSH
- umělé dýchání * MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: The optimal dose of dexamethasone for severe/critical COVID-19 is uncertain. We compared higher versus standard doses of dexamethasone in adults with COVID-19 and hypoxia. METHODS: We searched PubMed and trial registers until 23 June 2023 for randomised clinical trials comparing higher (>6 mg) versus standard doses (6 mg) of dexamethasone in adults with COVID-19 and hypoxia. The primary outcome was mortality at 1 month. Secondary outcomes were mortality closest to 90 days; days alive without life support; and the occurrence of serious adverse events/reactions (SAEs/SARs) closest to 1 month. We assessed the risk of bias using the Cochrane RoB2 tool, risk of random errors using trial sequential analysis, and certainty of evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: We included eight trials (2478 participants), of which four (1293 participants) had low risk of bias. Higher doses of dexamethasone probably resulted in little to no difference in mortality at 1 month (relative risk [RR] 0.97, 95% CI: 0.79-1.19), mortality closest to Day 90 (RR 1.01, 95% CI: 0.86-1.20), and SAEs/SARs (RR 1.00, 95% CI: 0.97-1.02). Higher doses of dexamethasone probably increased the number of days alive without invasive mechanical ventilation and circulatory support but had no effect on days alive without renal replacement therapy. CONCLUSIONS: Based on low to moderate certainty evidence, higher versus standard doses of dexamethasone probably result in little to no difference in mortality, SAEs/SARs, and days alive without renal replacement therapy, but probably increase the number of days alive without invasive mechanical ventilation and circulatory support.
- MeSH
- COVID-19 * MeSH
- dexamethason škodlivé účinky MeSH
- dospělí MeSH
- farmakoterapie COVID-19 MeSH
- hypoxie MeSH
- lidé MeSH
- pacienti MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- přehledy MeSH
- systematický přehled MeSH
- MeSH
- chronická myeloidní leukemie * farmakoterapie MeSH
- chronická nemoc MeSH
- inhibitory proteinkinas terapeutické užití MeSH
- inhibitory tyrosinkinasy MeSH
- lidé MeSH
- myeloidní leukemie * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Publikační typ
- abstrakt z konference MeSH
BACKGROUND: Providing palliative care at the end of life (EOL) in intensive care units (ICUs) seems to be modified during the COVID-19 pandemic with potential burden of moral distress to health care providers (HCPs). We seek to assess the practice of EOL care during the COVID-19 pandemic in ICUs in the Czech Republic focusing on the level of moral distress and its possible modifiable factors. METHODS: Between 16 June 2021 and 16 September 2021, a national, cross-sectional study in intensive care units (ICUs) in Czech Republic was performed. All physicians and nurses working in ICUs during the COVID-19 pandemic were included in the study. For questionnaire development ACADEMY and CHERRIES guide and checklist were used. A multivariate logistic regression model was used to analyse possible modifiable factors of moral distress. RESULTS: In total, 313 HCPs (14.5% out of all HCPs who opened the questionnaire) fully completed the survey. Results showed that 51.8% (n = 162) of respondents were exposed to moral distress during the COVID-19 pandemic. 63.1% (n = 113) of nurses and 71.6% of (n = 96) physicians had experience with the perception of inappropriate care. If inappropriate care was perceived, a higher chance for the occurrence of moral distress for HCPs (OR, 1.854; CI, 1.057-3.252; p = 0.0312) was found. When patients died with dignity, the chance for moral distress was lower (OR, 0.235; CI, 0.128-0.430; p < 0.001). The three most often reported differences in palliative care practice during pandemic were health system congestion, personnel factors, and characteristics of COVID-19 infection. CONCLUSIONS: HCPs working at ICUs experienced significant moral distress during the COVID-19 pandemic in the Czech Republic. The major sources were perceiving inappropriate care and dying of patients without dignity. Improvement of the decision-making process and communication at the end of life could lead to a better ethical and safety climate. TRIAL REGISTRATION: NCT04910243 .
- MeSH
- COVID-19 * epidemiologie MeSH
- jednotky intenzivní péče MeSH
- lidé MeSH
- mravy MeSH
- paliativní péče * MeSH
- pandemie MeSH
- postoj zdravotnického personálu MeSH
- průřezové studie MeSH
- průzkumy a dotazníky MeSH
- psychický stres MeSH
- smrt MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinická studie MeSH
- Geografické názvy
- Česká republika MeSH
Cíl studie: Léčba pacientů s těžkým průběhem onemocnění covid-19 (Coronavirus Disease 2019) kortikoidy je doporučena Světovou zdravotnickou organizací na základě výsledků studie RECOVERY. Stále však existuje mnoho otázek stran dávkování, načasování nebo volby konkrétní účinné látky. Toto dotazníkové šetření mělo za úkol zjistit, jakou strategii v podávání systémových kortikoidů skutečně praktikují lékaři ošetřující nemocné s covidem-19 na jednotkách intenzivní péče v České republice. Typ studie: Průřezové dotazníkové šetření. Materiál a metoda: Elektronický dotazník obsahující 15 otázek byl zaslán členům České společnosti anesteziologie, resuscitace a intenzivní medicíny, České společnosti intenzivní medicíny a České pneumologické a ftizeologické společnosti. Dotazník byl vyhodnocen pomocí deskriptivní statistické analýzy. Výsledky: Dotazník vyplnilo celkem 233 respondentů, z toho 231 odpovědí bylo analyzováno. Nejvíce zastoupenou skupinou respondentů byli sekundární lékaři s ukončeným specializačním vzděláváním v oboru Anesteziologie a intenzivní medicína (AIM) (32 %, n = 74). Nejčastější indikací k zahájení podávání kortikoidů u pacientů s covidem-19 byla probíhající oxygenoterapie (maskou nebo nosní kanylou) (59,3 %, n = 137) a vysokoprůtoková nosní kanyla (HFNC) (21,6 %, n = 50). Nejčastěji aplikovaným kortikoidem byl dexamethason (75,8 %, n = 175) v dávce 8 mg i. v. (48,6 %, n = 85), nebo v dávce 6 mg i. v. (32,0 %, n = 56), následován metylprednisolonem (25,5 %, n = 59) v dávce 80 mg i. v. (35,6%, n = 21), nebo v dávce 40 mg i. v. (13,6 %, n = 8). Nejčastější délka terapie byla 10 dnů dexamethason (60,6 %, n = 106), metylprednisolon (20,3 %, n = 12). Závěr: Zahájení kortikoidní terapie bylo nejčastěji indikováno u pacientů s covidem-19 a oxygenoterapií. Nejčastěji aplikovaným lékem byl dexamethason 8 mg i. v. a 6 mg i. v. po dobu 10 dnů.
Study objective: Administration of systemic corticosteroids in patients with severe COVID-19 (Coronavirus Disease 2019) has been recommended by World Health Organization (WHO) according to the RECOVERY trial results. However, there is still ongoing debate regarding the evidence supporting the dose, timing, route of administration and type of corticosteroid. This survey aimed to describe the current clinical practice of administration of systemic corticosteroids for patients with COVID-19 within Intensive Care Units (ICU) in Czech Republic. Study design: cross-sectional survey Material and methods: Electronic survey containing 15 questions was sent to the members of Czech Society of Anaesthesiology, Resuscitation and Intensive Care, Czech Society of Intensive care and Czech Pneumological and Phthisiological Society members. The results were analysed by descriptive statistic methods. Results: The survey fulfilled 233 respondents and 231 answers were eligible for analysis. The most prevalent group was attending physician with completed training in anaesthesiology and intensive care medicine (AIM) (32 %, n = 74). The most prevalent indication for initiation of corticosteroid treatment was oxygen therapy (face mask or nasal cannula) (59,3 %, n = 137) and high-flow nasal oxygen therapy (HFNC) (21,6 %, n = 50). The most preferred corticosteroid was dexamethasone (75,8 %, n = 175) at dose of 8 mg intravenously (i. v.) (48,6 %, n = 85), or dose of 6 mg i. v. (32,0 %, n = 56) followed by methylprednisolone (25,5 %, n= 59) at dose of 80 mg i. v. (35,6 %, n = 21), and 40 mg i. v. (13,6 %, n = 8), respectively. The preferred duration of therapy was 10 days (dexamethasone 60,6 %, n = 106, methylprednisolone 20,3 %, n = 12). Conclusion: Administration of corticosteroid was dominantly initiated in patients with severe COVID-19 receiving supplemental oxygen. The corticosteroid of first choice was intravenous dexamethasone at dose of 8 mg and 6 mg for 10 days, respectively.
BACKGROUND: Chemoradiotherapy-induced gastrointestinal toxicity may lead to a significant impairment of the oncological patient's quality of life, as well as to reduced adherence to the treatment, which may have a negative impact on survival and mortality rates. OBJECTIVE: The aim of this review was to investigate whether oral probiotic administration prevents chemotherapy (± radiotherapy)-induced gastrointestinal toxicity, particularly diarrhea. METHODS: We searched the MEDLINE, Web of Science, and SCOPUS databases for randomized controlled trials in English published between 1990 and 2020. We conducted statistical data analyses expressing the treatment effect size as a risk ratio (RR) together with a 95% confidence interval (CI). Implications are based on trials rated as having a low risk of bias (RoB). RESULTS: We included 8 trials (n = 697 participants), from which 3 studies rated as low RoB contained primary endpoint data; the risk of developing grade 3/4 diarrhea in patients receiving probiotics was reduced by 78% compared to the control group (RR = 0.22 [95% CI 0.05-1.08]; P = .06; n = 114 participants). Probiotics showed preventive effects in patients treated with chemotherapy alone (RR = 0.34 [0.12-0.94]; P = .04, n = 121 participants) and in patients with colorectal cancer (RR = 0.56 [0.34-0.92]; P = .02; n = 208 participants). The reduction in the incidence of overall diarrhea was not significant. CONCLUSIONS: Probiotics failed to prove a preventive effect of statistical significance against the development of severe and overall diarrhea in cancer patients treated with chemotherapy (± radiotherapy). However, we cannot rule out that the effects of probiotics are clinically relevant, especially in certain subgroups of patients. This needs to be clarified in further well-performed studies.
- MeSH
- kvalita života MeSH
- lidé MeSH
- nádory * farmakoterapie radioterapie komplikace MeSH
- probiotika * terapeutické užití MeSH
- průjem etiologie prevence a kontrola MeSH
- randomizované kontrolované studie jako téma MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
- systematický přehled MeSH
Cíl studie: Paliativní péče v závěru života je nezbytnou součástí komplexního přístupu k pacientům na jednotkách intenzivní péče (ICU, Intensive Care Unit). Cílem průzkumu bylo identifikovat subjektivní popis a praxi péče v závěru života na ICU v České republice. Typ studie: průřezová, dotazníková studie Materiál a metodika: Respondenty byli zdravotničtí pracovníci (lékař, sestra) s profesní praxí na ICU během pandemie COVID-19 (Coronavirus Disease 2019). Elektronický dotazník (40 položek) byl distribuován prostřednictvím odborných společností ČR zdravotníkům, kteří byli přímo zapojeni do péče o pacienty s COVIDEM-19. Vyhodnocení dat bylo provedeno pomocí deskriptivní statistické analýzy. Výsledky: Analyzováno bylo 313 vyplněných dotazníků. Respondenti uvedli až 15 různých pojmů pro označení péče v závěru života, nejčastěji byl uveden pojem paliativní péče (75,1 %, n = 235). U podpůrné terapie byla nejčastěji uvedena úprava dle potřeb pacienta, a to zejména navýšení sedativ. Naopak paušálně bylo uvedeno vysazení nejčastěji parenterální (35,8 %, n = 112) a enterální (17,3 %, n = 54) výživy. V rámci managementu orgánové podpory bylo uvedeno ukončení eliminačních metod (69,7 %, n = 218) a katecholaminů (60,4 %, n = 189). Nejméně se ukončovala umělá plicní ventilace (24,6 %, n = 77), zajištění dýchacích cest endotracheální kanylou (11,5 %,n = 36) a tracheostomickou kanylou (2,9 %, n = 9). Další vzdělávání v paliativní péči by uvítala většina dotazovaných. Závěr: Paliativní péče v závěru života je zásadním tématem nejen během pandemie COVID-19. Používaná terminologie v ČR i samotná praxe se mohou významně lišit. Pro vzdělávání a výzkum vedoucí ke sjednocení postupů na ICU je tak stále významný prostor.
Study goal: Palliative care is an essential part of a complex approach to patients in the intensive care unit (ICU). This study aimed to describe palliative care practice in ICU in the Czech Republic. Study type: a cross-sectional, questionnaire study Material and methods: The inclusion criteria for study participation were nurses or physicians taking care of patients in the ICU for patients with Coronavirus Disease 2019 (COVID-19). The participants could participate by filling out the electronic survey with 40 questions. The questionnaire was evaluated by descriptive statistical analysis. Results: 313 questionnaires were analyzed. Participants reported up to 15 different terms for end-of-life care, the most often being palliative care (75.1%, n=235). The supportive care, especially sedatives, was most frequently adjusted according to the patient’s needs. On the other hand, as a standard approach, the parenteral (35.8%, n=112) and enteral (17.3%, n=54) nutrition were most often withdrawn. Regarding organ support, renal replacement therapy (69.7%, n=218) and vasopressors (60.4%, n=189) were often withdrawn. The most rarely withdrawn organ support was artificial ventilation (24.6%, n=77), endotracheal intubation (11.5%,n=36), and tracheostomy cannula (2.9%, n=9). The majority of respondents would appreciate further education in palliative care. Conclusion: Palliative care is an essential theme not only in the COVID-19 pandemic. The palliative care terminology and practice used in the Czech Republic are heterogeneous. There is a space for further research and education in palliative care.
- Klíčová slova
- studie PEOpLE-C19,
- MeSH
- COVID-19 MeSH
- dospělí MeSH
- jednotky intenzivní péče * MeSH
- lidé středního věku MeSH
- lidé MeSH
- paliativní péče * MeSH
- pandemie MeSH
- průřezové studie MeSH
- průzkumy a dotazníky MeSH
- terminologie jako téma MeSH
- zdravotničtí pracovníci MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need of oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day is currently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and may miss important therapeutic potential or may prevent potential deleterious effects of higher doses of corticosteroids. METHODS: REMED is a prospective, open-label, randomised controlled trial testing the superiority of dexamethasone 20 mg (dexamethasone 20 mg on days 1-5, followed by dexamethasone 10 mg on days 6-10) vs 6 mg administered once daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. Three hundred participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised in a 1:1 ratio into one of the two treatment arms. The following stratification factors will be applied: age, Charlson Comorbidity Index, CRP levels and trial centre. The primary endpoint is the number of ventilator-free days (VFDs) at 28 days after randomisation. The secondary endpoints are mortality from any cause at 60 days after randomisation; dynamics of the inflammatory marker, change in WHO Clinical Progression Scale at day 14; and adverse events related to corticosteroids and independence at 90 days after randomisation assessed by the Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. The study will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. DISCUSSION: We aim to compare two different doses of dexamethasone in patients with moderate to severe ARDS undergoing mechanical ventilation regarding efficacy and safety. TRIAL REGISTRATION: EudraCT No. 2020-005887-70. ClinicalTrials.gov NCT04663555. Registered on December 11, 2020.
- MeSH
- COVID-19 * MeSH
- dexamethason škodlivé účinky MeSH
- dospělí MeSH
- farmakoterapie COVID-19 MeSH
- kvalita života MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- prospektivní studie MeSH
- randomizované kontrolované studie jako téma MeSH
- SARS-CoV-2 MeSH
- syndrom dechové tísně * diagnóza farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
- Publikační typ
- abstrakt z konference MeSH
