ABSTRACT
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other hand, as a standard approach, the parenteral (35.8%, n=112) and enteral (17.3%, n=54) nutrition were most often withdrawn. Regarding organ support, renal replacement therapy (69.7%, n=218) and vasopressors (60.4%, n=189) were often withdrawn. The most rarely withdrawn organ support was artificial ventilation (24.6%, n=77), endotracheal intubation (11.5%,n=36), and tracheostomy cannula (2.9%, n=9).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.
ABSTRACT
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 Anaesthesiol-ogy, 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 methylprednis-olone (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.
ABSTRACT
Background. Treatment-free remission (TFR) has become a new treatment goal for chronic myeloid leukemia (CML) patients. However, usually abrupt tyrosine kinase inhibitors (TKIs) therapy discontinuation has been successful only in about half of eligible patients and it can cause burdening TKI withdrawal syndrome (TWS) in about 30% of them. Moreover, any robust clinical or biological factor predictive for successful TFR has not been identified yet. On top of that, sustainable deep molecular response (DMR) as the main prerequisite for TKI discontinuation attempt is achieved only in 20-40% of patients. The majority of CML patients, therefore, need to be treated with the effective and well-tolerated drug for a long time or even life-long. Study design and methods. With the recognition of all these aspects, we designed a nationwide prospective investigator-initiated phase II clinical trial HALF (ClinicalTrials.gov NCT04147533) in order to evaluate efficacy and safety of TKI discontinuation after previous two-step dose reduction in patients with CML in DMR (Fig. 1). Step-wise TKI dose reduction, i.e. half of the standard during the first 6 months after study entry, and the same dose given alternatively (every other day) during the next 6 months, was derived from pharmacokinetics and experimental data as well as from clinical trials' results. We assume that the step-wise and eventually meaningful TKI dose reduction enables a higher rate of patients achieving successful TFR with less pronounce TWS, or even would represent a more reasonable and safer alternative to the complete and sudden TKI interruption. This unique nationwide academic project has been facilitated by hematological patients care centralization in the Czech Republic. A primary study objective is to evaluate the proportion of patients in major molecular response (MMR) at 6 and 12 months and in TFR at 18, 24, and 36 months after the study enrollment, respectively, and molecular recurrence-free survival at all mentioned time points as well. Main secondary and exploratory objectives are: to evaluate the proportion of patients loosing MMR and in whom MMR and MR4.0 would be re-achieved after TKI re-introduction, time to MMR and MR4.0 re-achievement, FFS, PFS, OS, TWS, and QoL assessment, predictive factors for successful TFR identification, quantification of BCR-ABL1 using digital droplet PCR at both the DNA and mRNA levels, immunological profiling, BCR-ABL1 kinetics mathematical modeling, assessment of TKI pharmacokinetics, clonal hematopoiesis and pharmaco-economics. Results. The study was launched in December 2019;however, due to the COVID-19 outbreak, patients' recruitment started on June 16, 2020. Here, characteristics of the first 74 patients included in the study until April 2021 are presented. There were 37 males and 37 females, with median age at the time of diagnosis of 53 years (range, 23-74) and at the time of the study entry of 67 years (range, 35-86). A median time of CML disease, TKI treatment, and DMR duration before the study initiation was as follows: 9.9 years (range, 4.4-22.5), 9.8 years (range, 4.2-20.2), and 7.3 years (range, 3.2-18.3), respectively. The ELTS score was low, intermediate, high and unknown in 62.2%, 21.6%, 13.5%, and 2.7% of patients, respectively. At the time of study entry, 58 patients (79.5%) were treated with imatinib, 10 (13.7%) with nilotinib, and 5 (6.8%) with dasatinib, respectively, whereas in 63 patients (86.3%) it was in the first line of therapy. With almost half of patients (48.6%), the TKI dose was already reduced at the time of study entry. With 10 (13.5%) patients, interferon-α treatment preceded TKI administration. At the time of this preparation, on July 26, 2021, altogether 102 patients (from planned 150) have been enrolled in the study;48 of them (47.1%) have already moved to the second de-escalation phase and 9 (8.8%) patients to the TFR phase. There were 2 cases of confirmed MMR loss (both in month 8 after the study entry) and no patient experienced symptoms resembling TWS. Conclusions. Despite the COVID-19 pandemic, the HALF study was successfully launched and initiated in the majority of centers, with 102 already included patients and continuing intensive enrolment. Based on our very preliminary results, the step-wise dose reduction seems to be an effective and safe approach. More included patients, longer follow-up and further analyses are needed in order to reach all set up objectives. [Formula presented] Disclosures: Žácková: Angelini: Consultancy, Speakers Bureau;Novartis: Speakers Bureau. Faber: Angelini: Consultancy, Other: conference fees, Research Funding, Speakers Bureau;Bristol-Myers Squibb: Consultancy, Other: conference fees, Research Funding, Speakers Bureau;Novartis: Consultancy, Other: conference fees, Research Funding, Speakers Bureau;Pfizer: Other: conference fees;TERUMO: Other: conference fees. Bělohlávková: Novartis: Consultancy;BMS/Celgene: Consultancy. Horňák: Angelini: Honoraria. Svobodník: Roche: Speakers Bureau;Janssen-Cilag: Speakers Bureau. Machová Poláková: Incyte: Consultancy;Angelini: Consultancy;Novartis: Research Funding. Mayer: Principia: Research Funding.