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1.
Crit Care Clin ; 38(3): 587-600, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1859370

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 infection leads to dysregulation of immune pathways. Therapies focusing on suppressing cytokine activity have some success. Current evidence supports the use of dexamethasone in hospitalized patients requiring oxygen to decrease mortality. Interleukin-6 inhibitors, like tocilizumab and sarilumab, are also beneficial in hypoxemic patients, if used early. Janus kinase inhibition in combination with glucocorticoids is emerging as a potential therapeutic option for patients with moderate to severe symptoms. Data on the role of anakinra, hyperimmune immunoglobulin/convalescent plasma, or plasma purification are limited.


Subject(s)
COVID-19 , SARS-CoV-2 , Anti-Inflammatory Agents/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/drug therapy , COVID-19/therapy , Humans , Immunization, Passive
2.
AJOB Empir Bioeth ; : 1-9, 2022 Apr 18.
Article in English | MEDLINE | ID: covidwho-1795422

ABSTRACT

BACKGROUND: Equitable protocols to triage life-saving resources must be specified prior to shortages in order to promote transparency, trust and consistency. How well proposed utilitarian protocols perform to maximize lives saved is unknown. We aimed to estimate the survival rates that would be associated with implementation of the New York State 2015 guidelines for ventilator triage, and to compare them to a first-come-first-served triage method. METHODS: We constructed a simulation model based on a modified version of the New York State 2015 guidelines compared to a first-come-first-served method under various hypothetical ventilator shortages. We included patients with SARs-CoV-2 infection admitted with respiratory failure requiring mechanical ventilation to three acute care hospitals in New York from 3/01/2020 and 5/27/2020. We estimated (1) survival rates, (2) number of excess deaths, (3) number of patients extubated early or not allocated a ventilator due to capacity constraints, (4) survival rates among patients not allocated a ventilator at triage or extubated early due to capacity constraints. RESULTS: 807 patients were included in the study. The simulation model based on a modified New York State policy did not decrease mortality, excess death or exclusion from ventilators compared to the first-come-first-served policy at every ventilator capacity we tested using COVID-19 surge cohort patients. Survival rates were similar at all the survival probabilities estimated. At the lowest ventilator capacity, the modified New York State policy has an estimated survival of 28.5% (CI: 28.4-28.6), compared to 28.1% (CI: 27.7-28.5) for the first-come-first-served policy. CONCLUSIONS: This simulation of a modified New York State guideline-based triage protocol revealed limitations in achieving the utilitarian goals these protocols are designed to fulfill. Quantifying these outcomes can inform a better balance among competing moral aims.

3.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-308534

ABSTRACT

Background: Equitable protocols to triage scarce life-saving resources must be specified prior to disasters in order to promote transparency, trust and consistency. The degree to which proposed utilitarian protocols may maximize lives saved is unknown.Methods: We constructed a simulation model based on New York State 2015 guidelines for ventilator triage (NYS) compared to a first-come-first-served (FCFS) method for ventilator allocation under various hypothetical ventilator shortages. We included patients with laboratory confirmed SARs-CoV-2 infection admitted with respiratory failure requiring mechanical ventilation to three acute care hospitals in New York from 3/01/2020 and 5/27/2020. We estimated (1) survival rates, (2) number of excess deaths, (3) number of patients extubated early due to capacity constraints, (4) survival rates among patients not allocated a ventilator at triage or extubated early due to capacity constraints.Findings: 807 patients were included in the study. Survival rates were similar between the NYS and FCFS policies at all the survival probabilities estimated for those triaged to removal of the ventilator. At the lowest ventilator capacity, the NYS policy has an estimated survival of 28.5% (CI: 28.4-28.6), compared to 28.1% (CI: 27.7-28.5) for the FCFS policy. The two policies had similar estimated excess deaths above historical observed deaths.Interpretation: This simulation of a SOFA-based triage protocol for distributing ventilators during the COVID-19 pandemic revealed limitations in achieving the utilitarian goals these protocols are designed to fulfill. Quantifying these outcomes can inform a better balance competing moral aims.Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: This study was approved by the Albert Einstein College of Medicine/Montefiore Medical Center IRB (IRB # 2020-12128) and the Columbia University IRB (IRB # AAAT4062).

4.
Critical care clinics ; 2022.
Article in English | EuropePMC | ID: covidwho-1678718

ABSTRACT

Synopsis: SARS-CoV-2 infection leads to dysregulation of immune pathways. Therapies focusing on suppressing cytokine activity have some success. Current evidence supports the use of dexamethasone in hospitalized patients requiring oxygen to decrease mortality. IL-6 inhibitors like tocilizumab and sarilumab are also beneficial in hypoxemic patients, if used early. JAK inhibition in combination with glucocorticoids is emerging as a potential therapeutic option for patients with moderate to severe symptoms. Data on the role of anakinra, hyperimmune immunoglobulin/convalescent plasma, or plasma purification is limited.

5.
N Engl J Med ; 385(9): 790-802, 2021 Aug 26.
Article in English | MEDLINE | ID: covidwho-1343498

ABSTRACT

BACKGROUND: Thrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19. METHODS: In this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level. RESULTS: The trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis. CONCLUSIONS: In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).


Subject(s)
Anticoagulants/administration & dosage , COVID-19/drug therapy , Heparin/administration & dosage , Thrombosis/prevention & control , Adult , Aged , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , COVID-19/mortality , Female , Hemorrhage/chemically induced , Heparin/adverse effects , Heparin/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Hospital Mortality , Humans , Male , Middle Aged , Survival Analysis
6.
N Engl J Med ; 385(9): 777-789, 2021 Aug 26.
Article in English | MEDLINE | ID: covidwho-1343497

ABSTRACT

BACKGROUND: Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS: In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS: The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis. CONCLUSIONS: In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin did not result in a greater probability of survival to hospital discharge or a greater number of days free of cardiovascular or respiratory organ support than did usual-care pharmacologic thromboprophylaxis. (REMAP-CAP, ACTIV-4a, and ATTACC ClinicalTrials.gov numbers, NCT02735707, NCT04505774, NCT04359277, and NCT04372589.).


Subject(s)
Anticoagulants/administration & dosage , COVID-19/drug therapy , Heparin/administration & dosage , Thrombosis/prevention & control , Aged , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , COVID-19/mortality , Critical Illness , Female , Hemorrhage/chemically induced , Heparin/adverse effects , Heparin/therapeutic use , Hospital Mortality , Humans , Logistic Models , Male , Middle Aged , Odds Ratio , Respiration, Artificial , Treatment Failure
7.
Chest ; 160(6): 2112-2122, 2021 12.
Article in English | MEDLINE | ID: covidwho-1272333

ABSTRACT

BACKGROUND: For patients with COVID-19 who undergo emergency endotracheal intubation, data are limited regarding the practice, outcomes, and complications of this procedure. RESEARCH QUESTION: For patients with COVID-19 requiring emergency endotracheal intubation, how do the procedural techniques, the incidence of first-pass success, and the complications associated with the procedure compare with intubations of critically ill patients before the COVID-19 pandemic? STUDY DESIGN AND METHODS: We conducted a retrospective study of adult patients with COVID-19 at Montefiore Medical Center who underwent first-time endotracheal intubation by critical care physicians between July 19, 2019, and May 1, 2020. The first COVID-19 patient was admitted to our institution on March 11, 2020; patients admitted before this date are designated the prepandemic cohort. Descriptive statistics were used to compare groups. A Fisher exact test was used to compare categorical variables. For continuous variables, a two-tailed Student t test was used for parametric variables or a Wilcoxon rank-sum test was used for nonparametric variables. RESULTS: One thousand two hundred sixty intubations met inclusion criteria (782 prepandemic cohort, 478 pandemic cohort). Patients during the pandemic were more likely to be intubated for hypoxemic respiratory failure (72.6% vs 28.1%; P < .01). During the pandemic, operators were more likely to use video laryngoscopy (89.4% vs 53.3%; P < .01) and neuromuscular blocking agents (86.0% vs 46.2%; P < .01). First-pass success was higher during the pandemic period (94.6% vs 82.9%; P < .01). The rate of associated complications was higher during the pandemic (29.5% vs 15.2%; P < .01), a finding driven by a higher rate of hypoxemia during or immediately after the procedure (25.7% vs 8.2%; P < .01). INTERPRETATION: Video laryngoscopy and neuromuscular blockade were used increasingly during the COVID-19 pandemic. Despite a higher rate of first-pass success during the pandemic, the incidence of complications associated with the procedure was higher.


Subject(s)
COVID-19/therapy , Critical Care , Intubation, Intratracheal/adverse effects , Postoperative Complications/epidemiology , Practice Patterns, Physicians' , Aged , Aged, 80 and over , COVID-19/complications , Female , Humans , Incidence , Laryngoscopy , Male , Middle Aged , Neuromuscular Blocking Agents , Patient Selection , Retrospective Studies , Treatment Outcome
8.
Otolaryngol Head Neck Surg ; 164(2): 300-301, 2021 02.
Article in English | MEDLINE | ID: covidwho-1125161

ABSTRACT

In the setting of COVID-19 (coronavirus disease 2019)-associated moderate and severe acute respiratory distress, persistently hypoxemic patients often require prone positioning for >16 hours. We report facial pressure wounds and ear necrosis as a consequence of prone positioning in patients undergoing ventilation in the intensive care unit in a tertiary medical center in New York City.


Subject(s)
COVID-19/therapy , Facial Injuries/etiology , Patient Positioning/adverse effects , Pressure Ulcer/etiology , Prone Position , Respiration, Artificial/adverse effects , COVID-19/complications , Critical Care , Ear/pathology , Facial Injuries/pathology , Humans , Necrosis , Pressure Ulcer/pathology
9.
Crit Care Explor ; 3(2): e0348, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-1093604

ABSTRACT

To determine the association between prone positioning in nonintubated patients with coronavirus disease 2019 and frequency of invasive mechanical ventilation or inhospital mortality. DESIGN: A nested case-matched control analysis. SETTING: Three hospital sites in Bronx, NY. PATIENTS: Adult coronavirus disease 2019 patients admitted between March 1, 2020, and April 1, 2020. We excluded patients with do-not-intubate orders. Cases were defined by invasive mechanical ventilation or inhospital mortality. Each case was matched with two controls based on age, gender, admission date, and hospital length of stay greater than index time of matched case via risk-set sampling. The presence of nonintubated proning was identified from provider documentation. INTERVENTION: Nonintubated proning documented prior to invasive mechanical ventilation or inhospital mortality for cases or prior to corresponding index time for matched controls. MEASUREMENTS AND MAIN RESULTS: We included 600 patients, 41 (6.8%) underwent nonintubated proning. Cases had lower Spo2/Fio2 ratios prior to invasive mechanical ventilation or inhospital mortality compared with controls (case median, 97 [interquartile range, 90-290] vs control median, 404 [interquartile range, 296-452]). Although most providers (58.5%) documented immediate improvement in oxygenation status after initiating nonintubated proning, there was no difference in worst Spo2/Fio2 ratios before and after nonintubated proning in both case and control (case median Spo2/Fio2 ratio difference, 3 [interquartile range, -3 to 8] vs control median Spo2/Fio2 ratio difference, 0 [interquartile range, -3 to 50]). In the univariate analysis, patients who underwent nonintubated proning were 2.57 times more likely to require invasive mechanical ventilation or experience inhospital mortality (hazard ratio, 2.57; 95% CI, 1.17-5.64; p = 0.02). Following adjustment for patient level differences, we found no association between nonintubated proning and invasive mechanical ventilation or inhospital mortality (adjusted hazard ratio, 0.92; 95% CI, 0.34-2.45; p = 0.86). CONCLUSIONS: There was no significant association with reduced risk of invasive mechanical ventilation or inhospital mortality after adjusting for baseline severity of illness and oxygenation status.

10.
11.
Ann Am Thorac Soc ; 18(4): 623-631, 2021 04.
Article in English | MEDLINE | ID: covidwho-858614

ABSTRACT

Rationale: How to provide advanced respiratory support for coronavirus disease (COVID-19) to maximize population-level survival while optimizing mechanical ventilator access is unknown.Objectives: To evaluate the use of high-flow nasal cannula for COVID-19 on population-level mortality and ventilator availability.Methods: We constructed dynamical (deterministic) simulation models of high-flow nasal cannula and mechanical ventilation use for COVID-19 in the United States. Model parameters were estimated through consensus based on published literature, local data, and experience. We had the following two outcomes: 1) cumulative number of deaths and 2) days without any available ventilators. We assessed the impact of various policies for the use of high-flow nasal cannula (with or without "early intubation") versus a scenario in which high-flow nasal cannula was unavailable.Results: The policy associated with the fewest deaths and the least time without available ventilators combined the use of high-flow nasal cannula for patients not urgently needing ventilators with the use of early mechanical ventilation for these patients when at least 10% of ventilator supply was not in use. At the national level, this strategy resulted in 10,000-40,000 fewer deaths than if high-flow nasal cannula were not available. In addition, with moderate national ventilator capacity (30,000-45,000 ventilators), this strategy led to up to 25 (11.8%) fewer days without available ventilators. For a 250-bed hospital with 100 mechanical ventilators, the availability of 13, 20, or 33 high-flow nasal cannulas prevented 81, 102, and 130 deaths, respectively.Conclusions: The use of high-flow nasal cannula coupled with early mechanical ventilation when supply is sufficient results in fewer deaths and greater ventilator availability.


Subject(s)
COVID-19/mortality , COVID-19/therapy , Cannula , Oxygen Inhalation Therapy/instrumentation , Respiration, Artificial/instrumentation , Adolescent , Adult , Aged , COVID-19/complications , Computer Simulation , Critical Care , Female , Hospital Mortality , Hospitalization , Humans , Male , Middle Aged , Oxygen Inhalation Therapy/statistics & numerical data , Procedures and Techniques Utilization , Respiration, Artificial/statistics & numerical data , Survival Rate , Treatment Outcome , United States , Ventilators, Mechanical , Young Adult
12.
J Hosp Med ; 15(8): 489-493, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-721649

ABSTRACT

The efficacy of glucocorticoids in COVID-19 is unclear. This study was designed to determine whether systemic glucocorticoid treatment in COVID-19 patients is associated with reduced mortality or mechanical ventilation. This observational study included 1,806 hospitalized COVID-19 patients; 140 were treated with glucocorticoids within 48 hours of admission. Early use of glucocorticoids was not associated with mortality or mechanical ventilation. However, glucocorticoid treatment of patients with initial C-reactive protein (CRP) ≥20 mg/dL was associated with significantly reduced risk of mortality or mechanical ventilation (odds ratio, 0.23; 95% CI, 0.08-0.70), while glucocorticoid treatment of patients with CRP <10 mg/dL was associated with significantly increased risk of mortality or mechanical ventilation (OR, 2.64; 95% CI, 1.39-5.03). Whether glucocorticoid treatment is associated with changes in mortality or mechanical ventilation in patients with high or low CRP needs study in prospective, randomized clinical trials.


Subject(s)
Coronavirus Infections/mortality , Coronavirus Infections/therapy , Glucocorticoids/therapeutic use , Pneumonia, Viral/mortality , Pneumonia, Viral/therapy , Respiration, Artificial/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Betacoronavirus , Body Mass Index , C-Reactive Protein/analysis , COVID-19 , Child , Child, Preschool , Comorbidity , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Female , Glucocorticoids/administration & dosage , Glucocorticoids/adverse effects , Humans , Infant , Male , Middle Aged , Pandemics , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Prospective Studies , SARS-CoV-2 , Time Factors , Young Adult
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