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
Tento přehledový článek nabízí souhrn nejdůležitějších nově publikovaných poznatků v oblasti kardiovaskulární problematiky v akutních stavech publikovaných v roce 2023. Zároveň se snažíme zasadit tyto nové poznatky do kontextu předchozích znalostí, abychom se vyhnuli zbytečnému efektu kyvadla. Tato publikace si tedy neklade za cíl změnit náš každodenní přístup, ale nabídnout čtenářům přehled zaznamenání hodných informací, které mohou být v rámci další péče zvažovány.
This review article offers a summary of the most essential newly published findings in the field of cardiovascular issues in acute conditions published in 2023. At the same time, we try to place these new findings in the context of previous knowledge to avoid an unnecessary pendulum effect. This publication does not intend to alter our daily approach; instead, it provides readers with an overview of noteworthy information that could contribute to future care considerations.
- MeSH
- kardiogenní šok MeSH
- lidé MeSH
- péče o pacienty v kritickém stavu * MeSH
- šok terapie MeSH
- srdeční zástava * MeSH
- tekutinová terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- přehledy MeSH
BACKGROUND: To test the hypothesis that Hypotension probability indicator (HPI) driven hemodynamic protocol use may decrease the exposition to hypotension (mean arterial pressure below 65 mmHg) during supratentorial intracranial procedures. METHODS: Patients undergoing supratentorial tumor resection under general anesthesia (ASA 1-3) were included into this randomized single center-controlled pilot trial. Patients in the control group (COV, N.=20) were managed based on the institutional standard to avoid hypotension. Patients in the intervention (INT, N.=20) group were managed using a protocol triggered by the HPI above 85 based on the stroke volume variation, dynamic elastance, and cardiac index parameters. The number of patients experiencing hypotension (mean arterial pressure below 65 mmHg) during the whole procedure and anesthesia maintenance phase was the primary outcome variable. The number of hypotensive periods, time spent in hypotension, and hypotension dose served as secondary outcome variables. Other clinically relevant parameters and postsurgical outcomes were screened. RESULTS: The number of patients who never experienced hypotension was significantly lower in the INT group during the anesthesia maintenance phase (10 (50%) vs. 16 (80%); P=0.049). In several other hemodynamic outcomes, a distinct numerical, but statistically non-significant trend towards lower hypotension exposition was observed. There were no significant differences in clinically relevant parameters. CONCLUSIONS: In this pilot trial, the HPI-based protocol decreased the incidence of hypotension during the anesthesia maintenance but non-significant trends among secondary outcomes were also documented. Larger trials are needed to confirm our findings.
- MeSH
- hypotenze * prevence a kontrola epidemiologie MeSH
- lidé MeSH
- mozek MeSH
- pilotní projekty MeSH
- pravděpodobnost MeSH
- prospektivní studie MeSH
- randomizované kontrolované studie jako téma MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- protokol klinické studie MeSH
Fluids are the cornerstone of therapy in all critically ill patients. During the last decades, we have made many steps to get fluid therapy personalized and based on individual needs. In patients with lung involvement-acute respiratory distress syndrome-finding the right amount of fluids after lung surgery may be extremely important because lung tissue is one of the most vulnerable to fluid accumulation. In the current narrative review, we focus on the actual perspectives of fluid therapy with the aim of showing the possibilities to tailor the treatment to a patient's individual needs using fluid responsiveness parameters and other therapeutic modalities.
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
The coronavirus disease (COVID-19) pandemic caused unprecedented research activity all around the world but publications from Central-Eastern European countries remain scarce. Therefore, our aim was to characterise the features of the pandemic in the intensive care units (ICUs) among members of the SepsEast (Central-Eastern European Sepsis Forum) initiative. We conducted a retrospective, international, multicentre study between March 2020 and February 2021. All adult patients admitted to the ICU with pneumonia caused by COVID-19 were enrolled. Data on baseline and treatment characteristics, organ support and mortality were collected. Eleven centres from six countries provided data from 2139 patients. Patient characteristics were: median 68, [IQR 60-75] years of age; males: 67%; body mass index: 30.1 [27.0-34.7]; and 88% comorbidities. Overall mortality was 55%, which increased from 2020 to 2021 (p = 0.004). The major causes of death were respiratory (37%), cardiovascular (26%) and sepsis with multiorgan failure (21%). 1061 patients received invasive mechanical ventilation (mortality: 66%) without extracorporeal membrane oxygenation (n = 54). The rest of the patients received non-invasive ventilation (n = 129), high flow nasal oxygen (n = 317), conventional oxygen therapy (n = 122), as the highest level of ventilatory support, with mortality of 50%, 39% and 22%, respectively. This is the largest COVID-19 dataset from Central-Eastern European ICUs to date. The high mortality observed especially in those receiving invasive mechanical ventilation renders the need of establishing national-international ICU registries and audits in the region that could provide high quality, transparent data, not only during the pandemic, but also on a regular basis.
- MeSH
- COVID-19 * epidemiologie terapie MeSH
- dospělí MeSH
- jednotky intenzivní péče MeSH
- kyslík MeSH
- lidé MeSH
- registrace MeSH
- respirační insuficience * epidemiologie terapie MeSH
- retrospektivní studie MeSH
- SARS-CoV-2 MeSH
- sepse * epidemiologie MeSH
- syndrom dechové tísně * MeSH
- umělé dýchání MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
V průběhu roku 2022 se světová intenzivní medicína postupně začala navracet do normálních kolejí, ačkoli jsme stále mohli pozorovat dopady pandemických vln onemocnění covid-19. V literatuře jsme mohli zaznamenat jednak publikace výzkumných studií „násilně ukončených“ pandemií, ale již také nové práce. V tomto přehledovém článku přinášíme výběr těch pravděpodobně nejzajímavějších publikovaných článků v oblasti jak obecné intenzivní medicíny, tak se zaměřením na kardiovaskulární problematiku.
In 2022, intensive medicine all around the world gradually began to return to standard tracks, although we could still observe the effects of the pandemic waves of the disease COVID-19. In the literature, we could note the publication of research studies of “violently terminated” pandemics and new works. This review article presents a selection of the most interesting published articles in general intensive care medicine and those focusing on cardiovascular issues.
- MeSH
- hemodynamika MeSH
- lidé MeSH
- péče o pacienty v kritickém stavu * MeSH
- srdeční zástava * terapie MeSH
- tekutinová terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- přehledy 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
Bartonella quintana byla v širším povědomí lékařské veřejnosti především počátkem minulého století v souvislosti s vý skytem tzv. zákopové horečky. V dnešní době se jedná o ne příliš častého původce infekční endokarditidy (IE) především u pacientů se sníženou funkcí imunitního systému. Záludností této bakterie je, že ve většině případů není detekovatelná v hemokultuře, nebo až po velmi dlouhé kultivaci. Definitivní diagnózu se většinou podaří určit až na základě polymerázové řetězové reakce (PCR) z odebraného chlopenního materiálu. Kazuistika prezentuje případ 69leté ženy přijaté do intenzivní péče původně pro bronchopneumonii, u které byla díky rutinně provedenému vstupnímu echokardiografickému vyšetření diagnostikována těžká chlopenní vada a následně bartonellová endokarditida. Předkládaná kazuistika se snaží vyzdvihnout význam rutinního echokardiografického vyšetření prováděného intenzivistou‑nekardiologem a taktéž upozornit na ne příliš častý případ kultivačně negativní endokarditidy.
The community of physicians was largely aware of Bartonella quintana especially at the beginning of the last century and in connec tion with occurence of so called trench fever. Today, it is a not very common cause of infectious endocarditis, especially in patients with immune compromise. The trickery of this bacterium is that in most cases it is not detectable in blood culture, or only after a very long cultivation. The definitive diagnosis can usually be made only on the basis of polymerase chain reaction (PCR) from the collected valve material. The case report presents the case onalosf a 69 year old woman admitted to intensive care, originally for bronchopneumonia, who was diagnosed with a severe valvular defect and endocarditis diagnosed with the aid of echocardiographic examination. Presented case report tries to highlight the importance of routine echocardiographic examination performed by an intensivist-non-cardiologist and also to draw attention to the not very common case of cultivation negative endocarditis.
- MeSH
- antibakteriální látky aplikace a dávkování terapeutické užití MeSH
- bakteriální endokarditida * diagnóza patologie terapie MeSH
- Bartonella quintana * izolace a purifikace patogenita MeSH
- bronchopneumonie MeSH
- diferenciální diagnóza MeSH
- echokardiografie MeSH
- lidé MeSH
- nemoci srdečních chlopní chirurgie diagnostické zobrazování MeSH
- senioři MeSH
- srdeční selhání diagnóza etiologie terapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- práce podpořená grantem MeSH
Stanovení funkce krevních destiček a plazmatického koagulačního systému patří v oborech anesteziologie a intenzivní péče mezi běžně prováděná vyšetření. Důvodem pro vyšetření krevní srážlivosti může být plánovaný či akutní operační výkon, spontánní krvácivé projevy, pooperační krvácení bez jasného zdroje, sledování efektu léčby antikoagulačních a protidestičkových léků, tromboembolie apod. Velmi často jde o situace naléhavé, kdy je s výhodou, pokud je možno tato vyšetření provést přímo u lůžka pacienta. Současná medicína nám nabízí několik tzv. point of care (POCT) přístrojů, které lze k tomuto účelu použít. V našem sdělení přinášíme přehled nejčastěji užívaných metod a přístrojů, které slouží k vyšetření krevní srážlivosti u lůžka pacienta.
Determination of platelet function and function of plasma coagulation system is one of the commonly performed examina tions in anesthesiology and intensive care. The reason for the examination of blood clotting may be planned or acute surgery, spontaneous bleeding, postoperative bleeding without a clear source, monitoring the effect of treatment with anticoagu lant and antiplatelet drugs, thromboembolism, etc. Very often these are urgent situations where it is advantageous if such examination can be performed directly at the patient's bedside. Current medicine offers us the possibility of using several so-called point of care (POCT) devices that can be used for this purpose. In our article, we provide an overview of the most common methods and devices that are used to examine blood clotting at the patient's bedside.
- Klíčová slova
- agregometrie,
- MeSH
- hemostáza fyziologie MeSH
- inhibitory agregace trombocytů MeSH
- lidé MeSH
- tromboelastografie metody přístrojové vybavení MeSH
- vyšetření krevní srážlivosti * metody přístrojové vybavení MeSH
- vyšetření u lůžka * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- přehledy MeSH
OBJECTIVES: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. TRIAL DESIGN: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. PARTICIPANTS: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. INCLUSION CRITERIA: Subjects will be eligible for the trial if they meet all of the following criteria: 1. Adult (≥18 years of age) at time of enrolment; 2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing); 3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy; 4. Moderate or severe ARDS according to Berlin criteria: • Moderate - PaO2/FiO2 100-200 mmHg; • Severe - PaO2/FiO2 < 100 mmHg; 5. Admission to ICU in the last 24 hours. EXCLUSION CRITERIA: Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. Fulfilled criteria for ARDS for ≥14 days at enrolment; 3. Pregnancy or breastfeeding; 4. Unwillingness to comply with contraception measurements from enrolment until at least 1 week after the last dose of dexamethasone (sexual abstinence is considered an adequate contraception method); 5. End-of-life decision or patient is expected to die within next 24 hours; 6. Decision not to intubate or ceilings of care in place; 7. Immunosuppression and/or immunosuppressive drugs in medical history: a) Systemic immunosuppressive drugs or chemotherapy in the past 30 days; b) Systemic corticosteroid use before hospitalization; c) Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrolment; d) Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock); 8. Current haematological or generalized solid malignancy; 9. Any contraindication for corticosteroid administration, e.g. • intractable hyperglycaemia; • active gastrointestinal bleeding; • adrenal gland disorders; • presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 10. Cardiac arrest before ICU admission; 11. Participation in another interventional trial in the last 30 days. INTERVENTION AND COMPARATOR: Dexamethasone solution for injection/infusion is the investigational medicinal product as well as the comparator. The trial will assess two doses, 20 mg (investigational) vs 6 mg (comparator). Patients in the intervention group will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10. Patients in the control group will receive dexamethasone 6 mg day 1-10. All authorized medicinal products containing dexamethasone in the form of solution for i.v. injection/infusion can be used. MAIN OUTCOMES: Primary endpoint: Number of ventilator-free days (VFDs) at 28 days after randomisation, defined as being alive and free from mechanical ventilation. SECONDARY ENDPOINTS: a) Mortality from any cause at 60 days after randomisation; b) Dynamics of inflammatory marker (C-Reactive Protein, CRP) change from Day 1 to Day 14; c) WHO Clinical Progression Scale at Day 14; d) Adverse events related to corticosteroids (new infections, new thrombotic complications) until Day 28 or hospital discharge; e) Independence at 90 days after randomisation assessed by 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 through telephone structured interviews using the Barthel Index. RANDOMISATION: Randomisation will be carried out within the electronic case report form (eCRF) by the stratified permuted block randomisation method. Allocation sequences will be prepared by a statistician independent of the study team. Allocation to the treatment arm of an individual patient will not be available to the investigators before completion of the whole randomisation process. The following stratification factors will be applied: • Age <65 and ≥ 65; • Charlson Comorbidity index (CCI) <3 and ≥3; • CRP <150 mg/L and ≥150 mg/L • Trial centre. Patients will be randomised in a 1 : 1 ratio into one of the two treatment arms. Randomisation through the eCRF will be available 24 hours every day. BLINDING (MASKING): This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is calculated to detect the difference of 3 VFDs at 28 days (primary efficacy endpoint) between the two treatment arms with a two-sided type I error of 0.05 and power of 80%. Based on data from a multi-centre randomised controlled trial in COVID-19 ARDS patients in Brazil and a multi-centre observational study from French and Belgian ICUs regarding moderate to severe ARDS related to COVID-19, investigators assumed a standard deviation of VFD at 28 days as 9. Using these assumptions, a total of 142 patients per treatment arm would be needed. After adjustment for a drop-out rate, 150 per treatment arm (300 patients per study) will be enrolled. TRIAL STATUS: This is protocol version 1.1, 15.01.2021. The trial is due to start on 2 February 2021 and recruitment is expected to be completed by December 2021. TRIAL REGISTRATION: The study protocol was registered on EudraCT No.:2020-005887-70, and on December 11, 2020 on ClinicalTrials.gov (Title: Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19 (REMED)) Identifier: NCT04663555 with a last update posted on February 1, 2021. FULL PROTOCOL: The full protocol (version 1.1) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the standard formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
- MeSH
- COVID-19 komplikace terapie MeSH
- délka pobytu MeSH
- dexamethason aplikace a dávkování MeSH
- glukokortikoidy aplikace a dávkování MeSH
- hodnocení ekvivalence jako téma MeSH
- klinické zkoušky, fáze II jako téma MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- progrese nemoci MeSH
- randomizované kontrolované studie jako téma MeSH
- SARS-CoV-2 MeSH
- syndrom dechové tísně etiologie terapie MeSH
- umělé dýchání * MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- dopisy MeSH
- protokol klinické studie MeSH