Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt

Patterns of C-reactive protein ratio response in severe community-acquired pneumonia: a cohort study

Submitted by Repositório Arca ([email protected]) on 2019-04-24T16:56:17Z No. of bitstreams: 1 license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5)Approved for entry into archive by Janaína Nascimento ([email protected]) on 2019-10-16T12:33:53Z (GMT) No. of bitstreams: 2 ve_Coelho_Luís_etal_INI_2012.pdf: 294307 bytes, checksum: 05a16071390405bcdf3017a5cfbd474c (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5)Made available in DSpace on 2019-10-16T12:33:53Z (GMT). No. of bitstreams: 2 ve_Coelho_Luís_etal_INI_2012.pdf: 294307 bytes, checksum: 05a16071390405bcdf3017a5cfbd474c (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2012Centro Hospitalar de Lisboa Ocidental. Hospital de São Francisco Xavier. Polyvalent Intensive Care Unit. Lisbon, Portugal / New University of Lisbon. Centro de Estudos de Doenças Crónicas. Faculty of Medical Sciences. Lisbon, Portugal.D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil / Instituto Nacional de Câncer. Postgraduate Program. Rio de Janeiro, Brazil.D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil / Instituto Nacional de Câncer. Postgraduate Program. Rio de Janeiro, Brazil.Fundação Rio de Janeiro. Instituto de Pesquisa Clínica Evandro Chagas. Rio de Janeiro, RJ, Brasil.Hospital Barra D’Or. Intensive Care Unit. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Imunofarmacologia. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Pulmonary Diseases Department. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Imunofarmacologia. Rio de Janeiro, RJ, Brasil.Centro Hospitalar de Lisboa Ocidental. Hospital de São Francisco Xavier. Polyvalent Intensive Care Unit. Lisbon, Portugal / New University of Lisbon. Centro de Estudos de Doenças Crónicas. Faculty of Medical Sciences. Lisbon, Portugal.Introduction: Community-acquired pneumonia (CAP) requiring intensive care unit (ICU) admission remains a severe medical condition, presenting ICU mortality rates reaching 30%. The aim of this study was to assess the value of different patterns of C-reactive protein (CRP)-ratio response to antibiotic therapy in patients with severe CAP requiring ICU admission as an early maker of outcome. Methods: In total, 191 patients with severe CAP were prospectively included and CRP was sampled every other day from D1 to D7 of antibiotic prescription. CRP-ratio was calculated in relation to D1 CRP concentration. Patients were classified according to an individual pattern of CRP-ratio response with the following criteria: fast response - when D5 CRP was less than or equal to 0.4 of D1 CRP concentration; slow response - when D5 CRP was > 0.4 and D7 less than or equal to 0.8 of D1 CRP concentration; nonresponse - when D7 CRP was > 0.8 of D1 CRP concentration. Comparison between ICU survivors and non-survivors was performed. Results: CRP-ratio from D1 to D7 decreased faster in survivors than in non-survivors (p = 0.01). The ability of CRPratio by D5 to predict ICU outcome assessed by the area under the ROC curve was 0.73 (95% Confidence Interval, 0.64 - 0.82). By D5, a CRP concentration above 0.5 of the initial level was a marker of poor outcome (sensitivity 0.81, specificity 0.58, positive likelihood ratio 1.93, negative likelihood ratio 0.33). The time-dependent analysis of CRP-ratio of the three patterns (fast response n = 66; slow response n = 81; nonresponse n = 44) was significantly different between groups (p < 0.001). The ICU mortality rate was considerably different according to the patterns of CRP-ratio response: fast response 4.8%, slow response 17.3% and nonresponse 36.4% (p < 0.001). Conclusions: In severe CAP, sequential evaluation of CRP-ratio was useful in the early identification of patients with poor outcome. The evaluation of CRP-ratio pattern of response to antibiotics during the first week of therapy was useful in the recognition of the individual clinical evolution

Role of organisational factors on the 'weekend effect' in critically ill patients in Brazil: a retrospective cohort analysis

Submitted by Janaína Nascimento ([email protected]) on 2019-02-07T11:22:51Z No. of bitstreams: 1 ve_Zampieri_Fernando_etal_INI_2018.pdf: 1857014 bytes, checksum: 3f16399e2c8e4351d5d911156f29da22 (MD5)Approved for entry into archive by Janaína Nascimento ([email protected]) on 2019-02-12T12:12:17Z (GMT) No. of bitstreams: 1 ve_Zampieri_Fernando_etal_INI_2018.pdf: 1857014 bytes, checksum: 3f16399e2c8e4351d5d911156f29da22 (MD5)Made available in DSpace on 2019-02-12T12:12:17Z (GMT). No. of bitstreams: 1 ve_Zampieri_Fernando_etal_INI_2018.pdf: 1857014 bytes, checksum: 3f16399e2c8e4351d5d911156f29da22 (MD5) Previous issue date: 2018Hospital do Coração. Instituto de Pesquisa. São Paulo, SP, Brasil / Hospital Alemão Oswaldo Cruz. São Paulo, SP, Brasil.Santa Casa de Misericórdia de Porto Alegre. Complexo Hospitalar. Unidade de Cuidados Intensivos. Porto Alegre, RS, Brasil.Hospital Israelita Albert Einstein. São Paulo, SP, Brasil.D’Or Institute for Research and Education. Department of Critical Care and Graduate Program in Translational Medicine. Rio de Janeiro, RJ, Brazil / Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Hospital São Francisco. Ribeirão Preto, SP, Brasil.Hospital São Luiz Brasil. Santo André, SP, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Rede Amil de Hospitais. Unidade de Cuidados Intensivos. Rio de Janeiro, RJ, Brasil.Hospital Barra D’Or. Rio de Janeiro, RJ, Brasil.Hospital São Luís. São Luís, MA, Brasil.Hospital São Lucas. Rio de Janeiro, RJ, Brasil.Hospital São Luiz. São Paulo, SP, Brazil / Hospital Samaritano. São Paulo, SP, Brasil.Hospital Alemão Oswaldo Cruz. São Paulo, SP, Brasil.Hospital Sírio-Libanês. São Paulo, SP, Brasil.Hospital Copa D’Or. Rio de Janeiro, RJ, Brasil.Hospital Quinta D’Or. Rio de Janeiro, RJ, Brasil.Hospital Esperança Olinda. Olinda, PE, Brasil.Hospital Santa Luzia. Brasília, DF, Brasil.Hospital Unimed Vitória. Vitória, ES, Brasil.D’Or Institute for Research and Education. Department of Critical Care and Graduate Program in Translational Medicine. Rio de Janeiro, RJ, Brazil.D’Or Institute for Research and Education. Department of Critical Care and Graduate Program in Translational Medicine. Rio de Janeiro, RJ, Brazil.Introduction: Higher mortality for patients admitted to intensive care units (ICUs) during the weekends has been occasionally reported with conflicting results that could be related to organisational factors. We investigated the effects of ICU organisational and staffing patterns on the potential association between weekend admission and outcomes in critically ill patients. Methods: We included 59 614 patients admitted to 78 ICUs participating during 2013. We defined ‘weekend admission’ as any ICU admission from Friday 19:00 until Monday 07:00. We assessed the association between weekend admission with hospital mortality using a mixed logistic regression model controlling for both patientlevel (illness severity, age, comorbidities, performance status and admission type) and ICU-level (decrease in nurse/bed ratio on weekend, full-time intensivist coverage, use of checklists on weekends and number of institutional protocols) confounders. We performed secondary analyses in the subgroup of scheduled surgical admissions. Results: A total of 41 894 patients (70.3%) were admitted on weekdays and 17 720 patients (29.7%) on weekends. In univariable analysis, weekend admitted patients had higher ICU (10.9% vs 9.0%, P<0.001) and hospital (16.5% vs 13.5%, P<0.001) mortality. After adjusting for confounders, weekend admission was not associated with higher hospital mortality (OR 1.05, 95%CI 0.99 to 1.12, P=0.095). However, a ‘weekend effect’ was still observed in scheduled surgical admissions, as well as in ICUs not using checklists during the weekends. For unscheduled admissions, no ‘weekend effect’ was observed regardless of ICU’s characteristics. For scheduled surgical admissions, a ‘weekend effect’ was present only in ICUs with a low number of implemented protocols and those with a reduction in the nurse/bed ratio and not applying checklists during weekends. Conclusions: ICU organisational factors, such as decreased nurse-to-patient ratio, absence of checklists and fewer standardised protocols, may explain, in part, increases in mortality in patients admitted to the ICU mortality on weekends

Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.13Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt