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Importance: Experimental data suggest that intravenous vitamin C may attenuate inflammation and vascular injury associated with sepsis and acute respiratory distress syndrome (ARDS). Objective: To determine the effect of intravenous vitamin C infusion on organ failure scores and biological markers of inflammation and vascular injury in patients with sepsis and ARDS. Design, Setting, and Participants: The CITRIS-ALI trial was a randomized, double-blind, placebo-controlled, multicenter trial conducted in 7 medical intensive care units in the United States, enrolling patients (N = 167) with sepsis and ARDS present for less than 24 hours. The study was conducted from September 2014 to November 2017, and final follow-up was January 2018. Interventions: Patients were randomly assigned to receive intravenous infusion of vitamin C (50 mg/kg in dextrose 5% in water, n = 84) or placebo (dextrose 5% in water only, n = 83) every 6 hours for 96 hours. Main Outcomes and Measures: The primary outcomes were change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 96 hours, and plasma biomarkers of inflammation (C-reactive protein levels) and vascular injury (thrombomodulin levels) measured at 0, 48, 96, and 168 hours. Results: Among 167 randomized patients (mean [SD] age, 54.8 years [16.7]; 90 men [54%]), 103 (62%) completed the study to day 60. There were no significant differences between the vitamin C and placebo groups in the primary end points of change in mean modified Sequential Organ Failure Assessment score from baseline to 96 hours (from 9.8 to 6.8 in the vitamin C group [3 points] and from 10.3 to 6.8 in the placebo group [3.5 points]; difference, -0.10; 95% CI, -1.23 to 1.03; P = .86) or in C-reactive protein levels (54.1 vs 46.1 µg/mL; difference, 7.94 µg/mL; 95% CI, -8.2 to 24.11; P = .33) and thrombomodulin levels (14.5 vs 13.8 ng/mL; difference, 0.69 ng/mL; 95% CI, -2.8 to 4.2; P = .70) at 168 hours. Conclusions and Relevance: In this preliminary study of patients with sepsis and ARDS, a 96-hour infusion of vitamin C compared with placebo did not significantly improve organ dysfunction scores or alter markers of inflammation and vascular injury. Further research is needed to evaluate the potential role of vitamin C for other outcomes in sepsis and ARDS. Trial Registration: ClinicalTrials.gov Identifier: NCT02106975.
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Ácido Ascórbico/administração & dosagem , Insuficiência de Múltiplos Órgãos/prevenção & controle , Síndrome do Desconforto Respiratório/tratamento farmacológico , Sepse/tratamento farmacológico , Vitaminas/administração & dosagem , Adulto , Idoso , Ácido Ascórbico/uso terapêutico , Biomarcadores/sangue , Proteína C-Reativa/análise , Método Duplo-Cego , Feminino , Humanos , Infusões Intravenosas , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Insuficiência de Múltiplos Órgãos/etiologia , Escores de Disfunção Orgânica , Síndrome do Desconforto Respiratório/complicações , Síndrome do Desconforto Respiratório/mortalidade , Sepse/complicações , Sepse/mortalidade , Trombomodulina/sangue , Vitaminas/uso terapêuticoRESUMO
PURPOSE: To test the primary hypothesis that a CPR video will reduce ICU patients' surrogates' anxiety when deciding code status, as measured by the Hamilton Anxiety Rating (HAM-A) Scale, as compared to the no video group. MATERIALS AND METHODS: This is a prospective randomized control trial. Twenty-seven ICU patients' surrogates were enrolled in the study after receiving an ICU team-led code status discussion. After the enrollment, twelve surrogates were randomized to the video group and fifteen to the no video group. The primary outcome of anxiety was quantified using the HAM-A Scale. Demographic information, clinical data, and patients' provenance information (Home vs. Not Home) were collected. The patients' severity of illness was calculated using the Sequential Organ Failure Assessment (SOFA) Score. RESULTS: The HAM-A score in the video group was 5.65 points lower than in the no video group ([ß = -5.65, 95% CI -11.12 -0.18] P = 0.04). The statistically significant difference was maintained when adjusting for patients' SOFA Score and patients' provenance (P = 0.03). CONCLUSION: CPR video used to supplement ICU team-led code status discussions reduced surrogates' anxiety, as compared to no video. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03630965.
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Reanimação Cardiopulmonar , Unidades de Terapia Intensiva , Ansiedade/prevenção & controle , Tomada de Decisões , Humanos , Projetos Piloto , Estudos ProspectivosRESUMO
BACKGROUND: The optimal dose and timing of enteral nutrition (EN) in septic shock are unclear. METHODS: We conducted a phase 3 single-center randomized controlled pilot trial comparing early trophic EN with "no EN" in mechanically ventilated adults with septic shock, with the hypothesis that implementing a protocol comparing early trophic EN with "no EN" in patients with septic shock would be feasible. Patients were randomized to early trophic EN or "no EN" until off vasopressor for 3 hours. The primary outcome was feasibility in achieving >75% consent and compliance rate and <10% contamination rate. RESULTS: One hundred thirty-one patients were eligible for enrollment, and 49 were available for consent. Thirty-one (86%) consented and were randomized and 100% of patients in the early EN arm and 94% in the "no EN" arm completed their protocols. While on vasopressors, early EN group received median 384 kcal, and the "no EN" group received median 0 kcal. Contamination rate was 0 in the early trophic EN arm and 6% in the "no EN" arm. The early EN group had median 25 intensive care unit-free days, as compared with 12 in the "no EN" arm (P = .014). The early EN arm had median 27 ventilator-free days, compared with 14 in "no EN" arm (P = .009). CONCLUSION: Our protocol comparing early trophic EN with "no EN" in septic shock was feasible. Early trophic EN may be beneficial, but a larger multicenter trial is warranted to confirm the observed clinical benefits seen in this trial.
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Nutrição Enteral , Choque Séptico , Adulto , Humanos , Unidades de Terapia Intensiva , Tempo de Internação , Projetos Piloto , Respiração Artificial , Choque Séptico/terapia , Resultado do TratamentoRESUMO
BACKGROUND: Computed tomography (CT) methods to estimate sarcopenia in obesity do not differentiate high-attenuating from low-attenuating muscle. The primary purpose of this study was to determine agreement between a CT method using general workstation-derived total and high-attenuating psoas muscle cross-sectional area (CSA) and a commercially available segmentation software-derived value. Secondary purpose was to explore the relationship between quantity of high-attenuating muscle to physical functioning in a pilot cohort of obese medical intensive care unit (MICU) patients. METHODS: We conducted a prospective observational cross-sectional study. CT images of obese MICU patients were reconstructed to calculate total psoas muscle, low-attenuating muscle, and high-attenuating muscle within the third lumbar psoas CSA using a CT method and commercial software. We performed blinded outcome measures of CSA, physical function, and muscle strength in 28 patients. RESULTS: Concordance correlation coefficient for identifying total psoas muscle was 0.96 (95% confidence interval: 0.93-0.98, P-value < 0.0001) between CT method and commercial software. There was moderate correlation between modified Medical Research Council muscle strength scores and high-attenuating psoas muscle CSA (r = 0.47, P = 0.01) and lower extremity strength and high-attenuating psoas muscle CSA (r = 0.40, P = 0.04). CONCLUSION: There was strong agreement between our CT method and a commercial software method to identify total psoas muscle CSA in obesity. Greater total high-attenuating psoas CSA moderately correlated with muscle strength. Additional studies using more objective markers of muscle strength validating these findings are needed.
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Força Muscular , Obesidade/patologia , Músculos Psoas/diagnóstico por imagem , Sarcopenia/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Idoso , Anatomia Transversal , Estudos de Coortes , Estado Terminal , Estudos Transversais , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Obesidade/diagnóstico por imagem , Estudos Prospectivos , Músculos Psoas/patologia , SoftwareRESUMO
PURPOSE: To identify variables associated with 24-h mortality after inter-hospital transfer. MATERIALS AND METHODS: Single center retrospective study of adult patients transferred to a tertiary care medical ICU between 1 January 2010 and 15 April 2014. Demographic, clinical, physiologic, and laboratory data were collected. The Lasso method was used for logistic regression to identify predictors of 24-h mortality after inter-hospital ICU transfer. RESULTS: We identified 773 patients. Median age was 58 years (IQR 45-69), 49% were female, 83% Caucasian, and 48% had Medicare. The median length of stay at the transferring facility was 1.0 day (IQR 0-2). Median SOFA score on the day of ICU transfer was 5 (IQR 2-8). Twenty-two (3%) died within 24 h after inter-hospital transfer. SOFA score of 12-16 the day of inter-hospital transfer (odds ratio (OR) 7.77, 95% CI 1.21-66.26, p = 0.037), FiO2 0.8-1.0 on ICU arrival, and cardiac arrest prior to transfer (OR 4.94, 95% CI 1.43-15.96, p = 0.009) were associated with an increased risk for 24-h mortality after inter-hospital transfer. CONCLUSIONS: Our study identified biologically plausible and potentially modifiable factors associated with 24-h mortality after inter-hospital medical ICU transfer, which may serve to inform patients and families of readiness and risk for mortality after inter-hospital transfer.
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OBJECTIVE: Poor sign-out or handover of care may lead to preventable patient harm. Critically ill patients in intensive care units (ICU) are complex and prone to rapid clinical deterioration. If clinical deterioration occurs, timeliness of appropriate interventions is essential to prevent or reduce adverse outcomes. Therefore sign-outs need to efficiently transmit key information and provide anticipatory guidance. Interventions to improve resident-to-resident ICU sign-outs have not been well described. We conducted a controlled trial to test the effectiveness of a standardised ICU sign-out process to the usual ICU sign-out. DESIGN: Prospective controlled trial. SETTING: A 26-bed medical intensive care unit (MICU) in an urban tertiary academic medical centre. SUBJECTS: Residents rotating through the MICU. INTERVENTIONS: ICU-specific written sign-out template. METHODS: Residents completed postcall surveys assessing satisfaction with verbal and written sign-outs and incidence of non-routine events. Our main outcome of interest was the occurrence of non-routine events. MAIN RESULTS: Compared with the intervention group, on significantly more nights, night float residents in the control group encountered patients who were sicker than sign-out would have suggested (15.94% vs 43.75%; p<0.0001). On significantly fewer nights, night float residents in the intervention group indicated that either something happened to patients that was unexpected (18.84% vs 36.51%; p=0.023) or they were insufficiently prepared for (4.35% vs 35.94%; p<0.0001). Similarly, on fewer nights, residents in the intervention group indicated that they had to perform interventions that were unplanned or unanticipated (15.9% vs 37.7%; p=0.005). CONCLUSION: A structured sign-out process compared with usual sign-out significantly reduced the occurrence of non-routine events in an academic MICU.