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  1. Article ; Online: The Burden of Mental Illness Among Survivors of Critical Care-Risk Factors and Impact on Quality of Life: A Multicenter Prospective Cohort Study.

    Teixeira, Cassiano / Rosa, Regis Goulart / Sganzerla, Daniel / Sanchez, Evelin C / Robinson, Caroline Cabral / Dietrich, Camila / Kochhann, Renata / de Souza, Denise / Rech, Gabriela S / da R Dos Santos, Rosa / Schneider, Daniel / Boldo, Rodrigo / Sharshar, Tarek / Bozza, Fernando Augusto / Falavigna, Maicon / Friedman, Gilberto

    Chest

    2021  Volume 160, Issue 1, Page(s) 157–164

    Abstract: Background: Survivors of critical care may demonstrate mental health disorders in the months after discharge.: Research question: What are risk factors for mental health disorders after ICU discharge and is there an association between the burden of ... ...

    Abstract Background: Survivors of critical care may demonstrate mental health disorders in the months after discharge.
    Research question: What are risk factors for mental health disorders after ICU discharge and is there an association between the burden of mental illness and health-related quality of life (HRQoL)?
    Study design and methods: Multicenter prospective cohort study that included 579 adult ICU survivors with an ICU stay of > 72 h in 10 ICUs.
    Results: The outcomes were anxiety and depression assessed by the Hospital Anxiety and Depression Scale, posttraumatic stress disorder (PTSD) assessed by the Impact Event Scale 6, and HRQoL assessed by the Short Form 12 version 2. The 6-month prevalences of any mental health disorder were 36.2% (the prevalences of anxiety, depression, and PTSD were 24.2%, 20.9%, and 15.4%, respectively). ICU survivors with mental health disorders showed worse HRQoL scores in both physical and mental dimensions than those without. The higher the number of psychiatric syndromes manifested, the worse the mental dimension of HRQoL. Age of < 65 years (P = .009), history of depression (P = .009), anxiety (P = .003) and depression (P = .02) symptoms at ICU discharge, physical dependence (P = .01), and decreased physical functional status (P = .04) at 6 months were associated with anxiety. History of depression (P = .001), depression symptoms at ICU discharge (P < .001), and decreased physical functional status at 6 months (P = .01) were associated with depression. Depression symptoms at ICU discharge (P = .01), physical dependence (P = .01), and decreased physical functional status (P = .02) at 6 months were associated with PTSD.
    Interpretation: The network of potential risk factors for mental illness among patients discharged from an ICU is complex and involves multiple factors (age, premorbid mental health, acute emotional stress, and physical impairment after ICU stay). The negative impact of the burden of mental illness on HRQoL among critical care survivors is of concern.
    MeSH term(s) Aged ; Anxiety/epidemiology ; Anxiety/psychology ; Brazil/epidemiology ; Critical Care/methods ; Critical Illness/epidemiology ; Critical Illness/psychology ; Depression/epidemiology ; Depression/psychology ; Female ; Follow-Up Studies ; Humans ; Incidence ; Intensive Care Units/statistics & numerical data ; Male ; Mental Health ; Middle Aged ; Prospective Studies ; Risk Factors ; Surveys and Questionnaires ; Survivors/psychology
    Language English
    Publishing date 2021-02-25
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 1032552-9
    ISSN 1931-3543 ; 0012-3692
    ISSN (online) 1931-3543
    ISSN 0012-3692
    DOI 10.1016/j.chest.2021.02.034
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.

    Vlaar, Alexander P J / Witzenrath, Martin / van Paassen, Pieter / Heunks, Leo M A / Mourvillier, Bruno / de Bruin, Sanne / Lim, Endry H T / Brouwer, Matthijs C / Tuinman, Pieter R / Saraiva, José F K / Marx, Gernot / Lobo, Suzana M / Boldo, Rodrigo / Simon-Campos, Jesus A / Cornet, Alexander D / Grebenyuk, Anastasia / Engelbrecht, Johannes M / Mukansi, Murimisi / Jorens, Philippe G /
    Zerbib, Robert / Rückinger, Simon / Pilz, Korinna / Guo, Renfeng / van de Beek, Diederik / Riedemann, Niels C

    The Lancet. Respiratory medicine

    2022  Volume 10, Issue 12, Page(s) 1137–1146

    Abstract: Background: Vilobelimab, an anti-C5a monoclonal antibody, was shown to be safe in a phase 2 trial of invasively mechanically ventilated patients with COVID-19. Here, we aimed to determine whether vilobelimab in addition to standard of care improves ... ...

    Abstract Background: Vilobelimab, an anti-C5a monoclonal antibody, was shown to be safe in a phase 2 trial of invasively mechanically ventilated patients with COVID-19. Here, we aimed to determine whether vilobelimab in addition to standard of care improves survival outcomes in this patient population.
    Methods: This randomised, double-blind, placebo-controlled, multicentre phase 3 trial was performed at 46 hospitals in the Netherlands, Germany, France, Belgium, Russia, Brazil, Peru, Mexico, and South Africa. Participants aged 18 years or older who were receiving invasive mechanical ventilation, but not more than 48 h after intubation at time of first infusion, had a PaO
    Findings: From Oct 1, 2020, to Oct 4, 2021, we included 368 patients in the ITT analysis (full analysis set; 177 in the vilobelimab group and 191 in the placebo group). One patient in the vilobelimab group was excluded from the primary analysis due to random assignment in error without treatment. At least one dose of study treatment was given to 364 (99%) patients (safety analysis set). 54 patients (31%) of 177 in the vilobelimab group and 77 patients (40%) of 191 in the placebo group died in the first 28 days. The all-cause mortality rate at 28 days was 32% (95% CI 25-39) in the vilobelimab group and 42% (35-49) in the placebo group (hazard ratio 0·73, 95% CI 0·50-1·06; p=0·094). In the predefined analysis without site-stratification, vilobelimab significantly reduced all-cause mortality at 28 days (HR 0·67, 95% CI 0·48-0·96; p=0·027). The most common TEAEs were acute kidney injury (35 [20%] of 175 in the vilobelimab group vs 40 [21%] of 189 in the placebo), pneumonia (38 [22%] vs 26 [14%]), and septic shock (24 [14%] vs 31 [16%]). Serious treatment-emergent adverse events were reported in 103 (59%) of 175 patients in the vilobelimab group versus 120 (63%) of 189 in the placebo group.
    Interpretation: In addition to standard of care, vilobelimab improves survival of invasive mechanically ventilated patients with COVID-19 and leads to a significant decrease in mortality. Vilobelimab could be considered as an additional therapy for patients in this setting and further research is needed on the role of vilobelimab and C5a in other acute respiratory distress syndrome-causing viral infections.
    Funding: InflaRx and the German Federal Government.
    MeSH term(s) Humans ; COVID-19/therapy ; SARS-CoV-2 ; Critical Illness/therapy ; Respiration, Artificial ; Treatment Outcome ; Antibodies, Monoclonal ; Double-Blind Method
    Chemical Substances vilobelimab (F5T0RF9ZJA) ; Antibodies, Monoclonal
    Language English
    Publishing date 2022-09-07
    Publishing country England
    Document type Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2686754-0
    ISSN 2213-2619 ; 2213-2600
    ISSN (online) 2213-2619
    ISSN 2213-2600
    DOI 10.1016/S2213-2600(22)00297-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Quality of life after intensive care unit: a multicenter cohort study protocol for assessment of long-term outcomes among intensive care survivors in Brazil.

    Robinson, Caroline Cabral / Rosa, Regis Goulart / Kochhann, Renata / Schneider, Daniel / Sganzerla, Daniel / Dietrich, Camila / Sanchez, Évelin Carneiro / Dutra, Francine Hoffmann / Oliveira, Maicon Quadro de / Anzolin, Luisa Barbosa / Menezes, Suelen Fardim de / Jeffman, Rodrigo / Souza, Denise de / Silva, Sâmia Faria da / Cruz, Luciane Nascimento / Boldo, Rodrigo / Cardoso, Juliana Rezende / Birriel, Daniella Cunha / Gamboa, Mariana Nunes /
    Machado, André Sant'Ana / Andrade, Juliana Mara Stormosvski de / Alencar, Cesar / Teixeira, Michelle Carneiro / Vieira, Silvia Regina Rios / Moreira, Fernanda Caleffe / Amaral, Alexandre / Silveira, Ana Paula Menezes / Teles, José Mario Meira / Oliveira, Daniela Cunha de / Oliveira Júnior, Lúcio Couto de / Castro, Lívia Correa E / Silva, Marli Sarmento da / Neves, Rafael Trevizoli / Gomes, Renata de Andrade / Ribeiro, Cinthia Mucci / Cavalcanti, Alexandre Biasi / Oliveira, Roselaine Pinheiro de / Maccari, Juçara Gasparetto / Berto, Paula Pinheiro / Martins, Lucieda Araújo / Santos, Rui Leandro da Silva / Ue, Luciana Yumi / Hammes, Luciano Serpa / Sharshar, Tarek / Bozza, Fernando / Falavigna, Maicon / Teixeira, Cassiano

    Revista Brasileira de terapia intensiva

    2019  Volume 30, Issue 4, Page(s) 405–413

    Abstract: Objective: To establish the prevalence of physical, cognitive and psychiatric disabilities, associated factors and their relationship with the qualities of life of intensive care survivors in Brazil.: Methods: A prospective multicenter cohort study ... ...

    Title translation Qualidade de vida pós-unidades de terapia intensiva: protocolo de estudo de coorte multicêntrico para avaliação de desfechos em longo prazo em sobreviventes de internação em unidades de terapia intensiva brasileiras.
    Abstract Objective: To establish the prevalence of physical, cognitive and psychiatric disabilities, associated factors and their relationship with the qualities of life of intensive care survivors in Brazil.
    Methods: A prospective multicenter cohort study is currently being conducted at 10 adult medical-surgical intensive care units representative of the 5 Brazilian geopolitical regions. Patients aged ≥ 18 years who are discharged from the participating intensive care units and stay 72 hours or more in the intensive care unit for medical or emergency surgery admissions or 120 hours or more for elective surgery admissions are consecutively included. Patients are followed up for a period of one year by means of structured telephone interviews conducted at 3, 6 and 12 months after discharge from the intensive care unit. The outcomes are functional dependence, cognitive dysfunction, anxiety and depression symptoms, posttraumatic stress symptoms, health-related quality of life, rehospitalization and long-term mortality.
    Discussion: The present study has the potential to contribute to current knowledge of the prevalence and factors associated with postintensive care syndrome among adult intensive care survivors in Brazil. In addition, an association might be established between postintensive care syndrome and health-related quality of life.
    MeSH term(s) Anxiety/epidemiology ; Brazil ; Cognitive Dysfunction/epidemiology ; Cohort Studies ; Critical Care ; Depression/epidemiology ; Follow-Up Studies ; Humans ; Intensive Care Units ; Patient Discharge ; Prevalence ; Prospective Studies ; Quality of Life ; Survivors/psychology ; Time Factors
    Language English
    Publishing date 2019-01-10
    Publishing country Brazil
    Document type Journal Article ; Multicenter Study
    ZDB-ID 2732162-9
    ISSN 1982-4335 ; 1982-4335
    ISSN (online) 1982-4335
    ISSN 1982-4335
    DOI 10.5935/0103-507X.20180063
    Database MEDical Literature Analysis and Retrieval System OnLINE

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