scholarly journals Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (3) ◽  
pp. e1003415
Author(s):  
María Elvira Balcells ◽  
Luis Rojas ◽  
Nicole Le Corre ◽  
Constanza Martínez-Valdebenito ◽  
María Elena Ceballos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Clearance Rate ◽  
Neutralizing Antibodies ◽  
Statistical Power ◽  
Primary Outcome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Group Versus ◽  
Hospital Length Of Stay

Background Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. Methods and findings The study was an open-label, single-center randomized clinical trial performed in an academic medical center in Santiago, Chile, from May 10, 2020, to July 18, 2020, with final follow-up until August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptom onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted of immediate CP (early plasma group) versus no CP unless developing prespecified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days, or death. The key secondary outcomes included time to respiratory failure, days of mechanical ventilation, hospital length of stay, mortality at 30 days, and SARS-CoV-2 real-time PCR clearance rate. Of 58 randomized patients (mean age, 65.8 years; 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We failed to find benefit in the primary outcome (32.1% versus 33.3%, odds ratio [OR] 0.95, 95% CI 0.32–2.84, p > 0.999) in the early versus deferred CP group. The in-hospital mortality rate was 17.9% versus 6.7% (OR 3.04, 95% CI 0.54–17.17 p = 0.246), mechanical ventilation 17.9% versus 6.7% (OR 3.04, 95% CI 0.54–17.17, p = 0.246), and prolonged hospitalization 21.4% versus 30.0% (OR 0.64, 95% CI, 0.19–2.10, p = 0.554) in the early versus deferred CP group, respectively. The viral clearance rate on day 3 (26% versus 8%, p = 0.204) and day 7 (38% versus 19%, p = 0.374) did not differ between groups. Two patients experienced serious adverse events within 6 hours after plasma transfusion. The main limitation of this study is the lack of statistical power to detect a smaller but clinically relevant therapeutic effect of CP, as well as not having confirmed neutralizing antibodies in donor before plasma infusion. Conclusions In the present study, we failed to find evidence of benefit in mortality, length of hospitalization, or mechanical ventilation requirement by immediate addition of CP therapy in the early stages of COVID-19 compared to its use only in case of patient deterioration. Trial registration NCT04375098.

scholarly journals Early Anti-SARS-CoV-2 Convalescent Plasma in Patients Admitted for COVID-19: A Randomized Phase II Clinical Trial

2020 ◽  
Author(s):  
María Elvira Balcells ◽  
Luis Rojas ◽  
Nicole Le Corre ◽  
Constanza Martínez-Valdebenito ◽  
María Elena Ceballos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Clearance Rate ◽  
Primary Outcome ◽  
Group Versus ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Open Label ◽  
Serious Adverse Events ◽  
Academic Center

Background: Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. Methods: Open-label, single-center, randomized clinical trial performed in an academic center in Santiago, Chile from May 10, 2020, to July 18, 2020, with final follow-up August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptoms onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted in immediate CP (early plasma group) versus no CP unless developing pre-specified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days or death. Key secondary outcomes included: time to respiratory failure, days of mechanical ventilation, hospital length-of-stay, mortality at 30 days, and SARS-CoV-2 RT-PCR clearance rate. Results: Of 58 randomized patients (mean age, 65.8 years, 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We found no benefit in the primary outcome (32.1% vs 33.3%, OR 0.95, 95% CI 0.32-2.84, p>0.99) in the early versus deferred CP group. In-hospital mortality rate was 17.9% vs 6.7% (OR 3.04, 95% CI 0.54-17.2, p=0.25), mechanical ventilation 17.9% vs 6.7% (OR 3.04, 95% CI 0.54-17.2, p=0.25), and prolonged hospitalization 21.4% vs 30% (OR 0.64, 95%CI, 0.19-2.1, p=0.55) in early versus deferred CP group, respectively. Viral clearance rate on day 3 (26% vs 8%, p=0.20) and day 7 (38% vs 19%, p=0.37) did not differ between groups. Two patients experienced serious adverse events within 6 or less hours after plasma transfusion. Conclusion: Immediate addition of CP therapy in early stages of COVID-19 -compared to its use only in case of patient deterioration- did not confer benefits in mortality, length of hospitalization or mechanical ventilation requirement.

scholarly journals 562. Tocilizumab for the Treatment of Severe COVID-19: A Retrospective, Multi-Center, Case-Matched Series

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S346-S346
Author(s):  
Sarah Norman ◽  
Sara Jones ◽  
David Reeves ◽  
Christian Cheatham
Keyword(s):  
Mechanical Ventilation ◽  
Length Of Stay ◽  
Hospital Mortality ◽  
Primary Outcome ◽  
Fungal Infections ◽  
Hospital Length ◽  
Hospitalized Patients ◽  
Hospital Length Of Stay ◽  
Matched Design ◽  
Median Hospital

Abstract Background At the time of this writing, there is no FDA approved medication for the treatment of COVID-19. One medication currently under investigation for COVID-19 treatment is tocilizumab, an interleukin-6 (IL-6) inhibitor. It has been shown there are increased levels of cytokines including IL-6 in severe COVID-19 hospitalized patients attributed to cytokine release syndrome (CRS). Therefore, inhibition of IL-6 receptors may lead to a reduction in cytokines and prevent progression of CRS. The purpose of this retrospective study is to utilize a case-matched design to investigate clinical outcomes associated with the use of tocilizumab in severe COVID-19 hospitalized patients. Methods This was a retrospective, multi-center, case-matched series matched 1:1 on age, BMI, and days since symptom onset. Inclusion criteria included ≥ 18 years of age, laboratory confirmed positive SARS-CoV-2 result, admitted to a community hospital from March 1st – May 8th, 2020, and received tocilizumab while admitted. The primary outcome was in-hospital mortality. Secondary outcomes included hospital length of stay, total mechanical ventilation days, mechanical ventilation mortality, and incidence of secondary bacterial or fungal infections. Results The following results are presented as tocilizumab vs control respectively. The primary outcome of in-hospital mortality for tocilizumab (n=26) vs control (n=26) was 10 (38%) vs 11 (42%) patients, p=0.777. The median hospital length of stay for tocilizumab vs control was 14 vs 11 days, p=0.275. The median days of mechanical ventilation for tocilizumab (n=21) vs control (n=15) was 8 vs 7 days, p=0.139, and the mechanical ventilation mortality was 10 (48%) vs 9 (60%) patients, p=0.463. In the tocilizumab group, for those expired (n=10) vs alive (n=16), 10 (100%) vs 7 (50%) patients respectively had a peak ferritin > 600 ng/mL, and 6 (60%) vs 8 (50%) patients had a peak D-dimer > 2,000 ng/mL. The incidence of secondary bacterial or fungal infections within 7 days of tocilizumab administration occurred in 5 (19%) patients. Conclusion These findings suggest that tocilizumab may be a beneficial treatment modality for severe COVID-19 patients. Larger, prospective, placebo-controlled trials are needed to further validate results. Disclosures Christian Cheatham, PharmD, BCIDP, Antimicrobial Resistance Solutions (Shareholder)

An Evidence-Based Protocol for Manual Prone Positioning of Patients With ARDS

2021 ◽  
Vol 41 (6) ◽  
pp. 55-60
Author(s):  
Patrick Ryan ◽  
Cynthia Fine ◽  
Christine DeForge
Keyword(s):  
Mechanical Ventilation ◽  
Acute Respiratory Distress Syndrome ◽  
Respiratory Distress Syndrome ◽  
Respiratory Distress ◽  
Distress Syndrome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Prone Positioning ◽  
Hypoxemic Respiratory Failure ◽  
Unplanned Extubations

Background Manual prone positioning has been shown to reduce mortality among patients with moderate to severe acute respiratory distress syndrome, but it is associated with a high incidence of pressure injuries and unplanned extubations. This study investigated the feasibility of safely implementing a manual prone positioning protocol that uses a dedicated device. Review of Evidence A search of CINAHL and Medline identified multiple randomized controlled trials and meta-analyses that demonstrated both the reduction of mortality when prone positioning is used for more than 12 hours per day in patients with acute respiratory distress syndrome and the most common complications of this treatment. Implementation An existing safe patient-handling device was modified to enable staff to safely perform manual prone positioning with few complications for patients receiving mechanical ventilation. All staff received training on the protocol and use of the device before implementation. Evaluation This study included 36 consecutive patients who were admitted to the medical intensive care unit at a large academic medical center because of hypoxemic respiratory failure/acute respiratory distress syndrome and received mechanical ventilation and prone positioning. Data were collected on clinical presentation, interventions, and complications. Sustainability Using the robust protocol and the low-cost device, staff can safely perform a low-volume, high-risk maneuver. This method provides cost savings compared with other prone positioning methods. Conclusions Implementing a prone positioning protocol with a dedicated device is feasible, with fewer complications and lower costs than anticipated.

Hemodynamic Response to Vasopressin Dosage of 0.03 Units/Min vs. 0.04 Units/Min in Patients With Septic Shock

2020 ◽  
pp. 088506662097718 ◽  
Author(s):  
Seth R. Bauer ◽  
Gretchen L. Sacha ◽  
Simon W. Lam ◽  
Lu Wang ◽  
Anita J. Reddy ◽  
...  
Keyword(s):  
Septic Shock ◽  
Primary Outcome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Initial Dosage ◽  
Hemodynamic Response ◽  
Adjusted Relative Risk ◽  
Covariate Balance ◽  
Academic Medical ◽  
Medical Intensive Care

Background: Arginine vasopressin (AVP) is suggested as an adjunct to norepinephrine in patients with septic shock. Guidelines recommend an AVP dosage up to 0.03 units/min, but 0.04 units/min is commonly used in practice based on initial studies. This study was designed to compare the incidence of hemodynamic response between initial fixed-dosage AVP 0.03 units/min and AVP 0.04 units/min. Methods: This retrospective, multi-hospital health system, cohort study included adult patients with septic shock receiving AVP as an adjunct to catecholamine vasopressors. Patients were excluded if they received an initial dosage other than 0.03 units/min or 0.04 units/min, or AVP was titrated within the first 6 hours of therapy. The primary outcome was hemodynamic response, defined as a mean arterial pressure ≥65 mm Hg and a decrease in catecholamine dosage at 6 hours after AVP initiation. Inverse probability of treatment weighting (IPTW) based on the propensity score for initial AVP dosage receipt was utilized to estimate adjusted exposure effects. Results: Of the 1536 patients included in the observed data, there was a nearly even split between initial AVP dosage of 0.03 units/min (n = 842 [54.8%]) and 0.04 units/min (n = 694 [45.2%]). Observed patients receiving AVP 0.03 units/min were more frequently treated at the main campus academic medical center (96.3% vs. 52.2%, p < 0.01) and in a medical intensive care unit (87.4% vs. 39.8%, p < 0.01). The IPTW analysis included 1379 patients with achievement of baseline covariate balance. There was no evidence for a difference between groups in the incidence of hemodynamic response (0.03 units/min 50.0% vs. 0.04 units/min 53.1%, adjusted relative risk 1.06 [95% CI 0.94, 1.20]). Conclusions: Initial AVP dosing varied by hospital and unit type. Although commonly used, an initial AVP dosage of 0.04 units/min was not associated with a higher incidence of early hemodynamic response to AVP in patients with septic shock.

scholarly journals Evaluation of a Multidisciplinary Pain, Agitation, and Delirium Guideline in Mechanically Ventilated Critically Ill Adults

2018 ◽  
Vol 54 (2) ◽  
pp. 119-124
Author(s):  
Melissa Heim ◽  
Ryan Draheim ◽  
Anna Krupp ◽  
Paula Breihan ◽  
Ann O’Rourke ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Critically Ill ◽  
Medical Center ◽  
Guideline Implementation ◽  
Academic Medical Center ◽  
Retrospective Chart Review ◽  
Hospital Length Of Stay ◽  
Mechanically Ventilated ◽  
The Impact ◽  
Daily Sedation Interruption

Background: A multidisciplinary team updated an institution-specific pain, agitation, and delirium (PAD) guideline based on the recommendations from the Society of Critical Care Medicine (SCCM) PAD guidelines. This institution-specific guideline emphasized protocolized sedation with increased as needed boluses, and nonbenzodiazepine infusions, daily sedation interruption, and pairing of spontaneous awakening (SAT) and breathing trials (SBT). Objective: The purpose of this study was to evaluate the impact of implementation of a PAD guideline on clinical outcomes and medication utilization in an academic medical center intensive care unit (ICU). It was hypothesized that implementation of an updated guideline would improve clinical outcomes and decrease usage of benzodiazepine infusions. Methods: Pre-post retrospective chart review of 2417 (1147 pre, 1270 post) critically ill, mechanically ventilated adults in a medical/surgical ICU over a 2-year period (1 year pre and post guideline implementation). Results: After guideline implementation, average ventilation days was reduced (3.98 vs 3.43 days, P = .0021), as well as ICU and hospital length of stay (LOS) (4.79 vs 4.34 days, P = .048 and 13.96 vs 12.97 days, P = .045, respectively). Hospital mortality (19 vs 19%, P = .96) and acute physiology and chronic health evaluation (APACHE) IV scores (77.28 vs 78.75, P = .27) were similar. After guideline implementation, the percentage of patients receiving midazolam infusions decreased (422/1147 [37%] vs 363/1270 patients [29%], P = .0001). The percentage of patients receiving continuous infusion propofol (679/1147 [59%] vs 896/1270 [70%], P = .0001) and dexmedetomidine (78/1147 [7%] vs 147/1270 [12%], P = .0001) increased. Conclusions: Implementing a multidisciplinary PAD guideline utilizing protocolized sedation and daily sedation interruption decreased ventilation days and ICU and hospital LOS while decreasing midazolam drip usage.

Accelerating the clinical trial start-up process for early-phase cancer studies: A test of process change to support rapid activation in an academic medical center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17507-e17507 ◽  
Author(s):  
Sheilah K Hurley ◽  
Therica M Miller ◽  
Rebecca Flores Stella ◽  
Keren Dunn ◽  
Ryan Schroeder ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cancer Center ◽  
Small Series ◽  
Academic Medical ◽  
One Year ◽  
Activation Times ◽  
High Level

e17507 Background: Clinical trial sponsors have strong scientific, financial, and regulatory interests in rapidly activating studies at participating sites. Academic medical centers have difficulty activating trials within a few weeks of sponsor agreement because, among other inefficiencies, they engage the necessary committee reviews, regulatory approvals, contracting, and budgeting in serial fashion. Incremental revisions in such workflows do not result in strong improvements. Methods: We redesigned our institutional workflow to complete clinical trial activation tasks within six weeks. Historical procedures were replaced rather than scrutinized. A high level leadership committee was required to change and integrate procedures across the medical center, and engage sponsors to improve their turnaround times. A web-based collaborative workflow tracking tool was created to help coordinate the necessary tasks and measure performance. Six clinical trials from the Cancer Center portfolio were used to test and improve the new workflow. Results: Clinical trial activation redesign took one year. For the six studies used as tests of change, the activation times were 49, 54, 78, 58, 62, and 32 days. Times in excess of 6 weeks were largely due to sponsor delays. Conclusions: Considerable effort is required to significantly alter a complex workflow like clinical trial activation. Appropriate priorities, leadership, staffing, and tools are required. Markedly shortened study activation for a small series of cancer trials taught our academic medical center lessons that will be useful for improving the process for all clinical trials, and will make us a better partner for pharmaceutical and academic sponsors as well as for investigator initiated research. [Table: see text]

scholarly journals Comparison of Clinical and Thrombotic Outcomes in Sars-Cov-2- Pneumonia Versus Other Viral Pneumonia in an Urban Academic Medical Center

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1956-1956
Author(s):  
Rachel N. Goldberg ◽  
Kevin Johns ◽  
William Ye ◽  
Jeff J. Mucksavage ◽  
John G. Quigley ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Renal Replacement Therapy ◽  
Medical Records ◽  
Research Funding ◽  
Medical Center ◽  
Academic Medical Center ◽  
Viral Pneumonia ◽  
Coagulation Cascade ◽  
Academic Medical ◽  
D Dimer

Abstract Title: Comparison of Clinical and Thrombotic Outcomes in SARS-CoV-2- Pneumonia versus Other Viral Pneumonia in an Urban Academic Medical Center Objective: To compare clinical and thrombotic outcomes in SARS-CoV-2 pneumonia versus other viral pneumonias. Introduction: Viral pneumonia (PNA) causes oxidative stress to the pulmonary vasculature, triggering endothelial dysfunction and activation of the coagulation cascade. Elevations in coagulation markers, including d-dimer and fibrinogen, have been observed. Recent studies indicate that SARS-CoV-2 infection causes endothelial cell injury, with activation of the coagulation cascade, and a high frequency of systemic thrombotic events. It remains unclear whether it is viral pneumonia itself, a specific viral strain (and/or viral load) that drives the clinical and thrombotic outcomes. Furthermore, limited data is available regarding clinical outcomes in a diverse patient population hospitalized with SARS-CoV-2 infection. This study is from a single urban medical center in Chicago, Illinois. Study Design: A retrospective cohort study evaluating the medical records of hospitalized adult patients admitted to University of Illinois Hospital and Health Sciences System (UIHHSS) with SARS-CoV-2 pneumonia or other viral (H1N1 or H3N2) pneumonia between 10/01/2017 and 09/01/2020. Methods: Patients were included if ≥18 years old, hospitalized, with a primary confirmed diagnosis of viral pneumonia (SARS-CoV-2, H1N1 or H3N2) based on ICD-10 code, viral diagnostic testing, diagnosis description, and appropriate clinical characteristics/imaging studies. Past medical history, inpatient medications, coagulation parameters, arterial/venous thrombotic outcomes, and other clinical outcomes (renal replacement therapy, mechanical ventilation, co-infection) were abstracted from UIHHSS electronic health record database. Results: Medical records of 257 patient with a primary diagnosis of pneumonia were reviewed, 199 patients with SARS-CoV-2 PNA (95 male, average age 58 years, 52% Hispanic, 37% non-Hispanic Black) and 58 patients with other viral PNA (24 male, average age 63 years, 21% Hispanic, 55% non-Hispanic Black; 34 with H3N2, 24 with H1N1). Coagulation parameters (maximum D-dimer, fibrinogen, INR) were similar in both groups; average D-dimer was &gt;3x ULN. Anticoagulation therapy was similarly prescribed in both groups (SARS-CoV-2, 95% vs 84%, H1N1 or H3N2), with prophylactic dose anticoagulation prescribed most frequently (73% vs 62%) and with high average compliance rates (89% vs 83%). Admission to the intensive care unit (ICU; 32% vs 29%) and the median length of stay (10 vs 4 days) was similar in both groups. Thrombotic events (n = 6, 3%) occurred only in SARS-CoV-2 PNA patients in the ICU: 3 pulmonary embolism (PE), 1 distal lower extremity deep vein thrombosis (DVT), 2 non-ST elevated myocardial infarctions (NSTEMI). There was a significantly higher incidence of use of renal replacement therapy (8.5% vs 0%, p=0.016) and mortality (15.6% vs 3.4%, p=0.048) in the SARS-CoV-2 PNA group compared to the H3N2/H1N1 PNA group. There were no differences in the rates of mechanical ventilation, the incidence of major bleeding or co-infection. In a multivariable logistic regression analysis, age (aOR 1.07), the presence of SARS-CoV-2 PNA (aOR 11.37), and ICU admission (aOR 41.95) were significantly associated with risk of mortality during hospitalization. Race and ethnicity were not associated with mortality. Conclusion: The overall incidence of thrombotic events was low and occurred only in the SARS-CoV-2 PNA group. The low rate of venous thrombosis detected in this group, especially in the ICU setting, is likely related to the reduced use of diagnostic studies during the first COVID-19 pandemic in 2020 and to the high rates of anticoagulation prophylaxis orders and compliance. SARS-CoV-2 PNA was associated with a higher rate of renal failure and mortality compared to patients with H3N2/H1N1 viral pneumonia. There was no difference in mortality rates between Hispanic and non-Hispanic and between Black and non-Black patients. This study suggests that SARS-CoV-2 pneumonia leads to greater endothelial dysfunction than that observed in H3N2/H1N1 viral pneumonia and that race/ethnicity does not drive mortality outcomes. Disclosures Benken: BMS: Research Funding; CareDx: Research Funding; Transplant Genomics: Research Funding; Daiichi Sankyo: Research Funding; Verici Dx: Research Funding.

scholarly journals Pharmacist-Driven Management of Chemotherapy Induced Nausea and Vomiting in Hospitalized Adult Oncology Patients. A Retrospective Comparative Study

2011 ◽  
Vol 2 (3) ◽  
Author(s):  
Ramy Elshaboury ◽  
Kathleen Green
Keyword(s):  
Practice Guidelines ◽  
Primary Outcome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Standard Of Care ◽  
Nausea And Vomiting ◽  
P Value ◽  
Potential Cost

Chemotherapy-induced nausea and vomiting (CINV) is a major adverse event associated with cancer treatments. There are clinical practice guidelines that assist practitioners in managing CINV. Many cancer centers develop protocols for physicians and pharmacists to guide prophylaxis and breakthrough treatments of CINV based on published guidelines. The purpose of this study was to evaluate the outcome differences between pharmacist and physician -driven management of CINV in adult hospitalized cancer patients in a large academic medical center. This is a single center retrospective chart review study. The primary outcome of the study was the number of breakthrough antiemetic doses needed throughout the hospitalization. A total of 106 adult patients receiving inpatient chemotherapy were reviewed for CINV management. Fifty-five patients (52%) were managed according to the pharmacist-driven protocol, and fifty-one patients (48%) were managed by the physician. There was no difference between the two groups in the primary outcome. Patients in the pharmacist-managed group needed 6.4 breakthrough antiemetic doses; whereas, patients in the physician managed group needed 5.9 doses throughout the hospital stay (P-value = 0.7). No difference was seen when results were adjusted for length of hospitalization. There was a difference in adherence to the institution CINV guidelines favoring the pharmacist-driven approach (85% versus 33%, P < 0.0001). In conclusion, pharmacist-run protocol for CINV management was as effective as the standard of care. Protocols that are based on practice guidelines may offer the advantage of care standardization and potential cost savings.   Type: Student Project

scholarly journals Effects of Methylprednisolone on Ventilator-Free Days in Mechanically Ventilated Patients with Acute Respiratory Distress Syndrome and COVID-19

2021 ◽  
Author(s):  
Mohamed Badr ◽  
Bruno De Oliveira ◽  
Khaled Abdallah ◽  
Ashraf Nadeem ◽  
Yeldho Varghese ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Acute Respiratory Distress Syndrome ◽  
Length Of Stay ◽  
Competing Risks ◽  
Primary Outcome ◽  
Distress Syndrome ◽  
Invasive Mechanical Ventilation ◽  
Hospital Length ◽  
Blood Cultures ◽  
Hospital Length Of Stay

Objectives: There are limited data regarding the efficacy of methylprednisolone in patients with acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) requiring invasive mechanical ventilation. We aimed to determine whether methylprednisolone increases the number of ventilator-free days (VFDs) among these patients. Design: Retrospective single-center study Setting: Intensive care unit Patients: All patients with ARDS due to confirmed SARS-CoV-2 infection and requiring invasive mechanical ventilation between 1 March and 29 May 2020 were included Interventions: None Measurements and Main Results: The primary outcome was ventilator-free days (VFDs) during the first 28 days, defined as being alive and free from mechanical ventilation. The primary outcome was analyzed with competing-risks regression based on Fine and Gray&rsquo;s proportional subhazards model. Death before day 28 was considered to be the competing event. A total of 77 patients met the inclusion criteria. Thirty-two patients (41.6%) received methylprednisolone. The median dose was 1 mg.kg-1 (IQR: 1-1.3 mg.kg-1) and median duration of 5 days (IQR:5-7 days). Patients who received methylprednisolone had a mean 18.8 VFDs (95% CI, 16.6-20.9) during the first 28 days vs. 14.2 VFDs (95% CI, 12.6-16.7) in patients who did not receive methylprednisolone (difference, 4.61; 95% CI, 1.10-8.12; P = 0.001). In the multivariable competing-risks regression analysis and after adjusting for potential confounders (ventilator settings, prone position, organ failure support, severity of the disease, tocilizumab, and inflammatory markers), methylprednisolone was independently associated with a higher number of VFDs (subhazards ratio: 0.10, 95%CI: 0.02-0.45; p=0.003). Hospital mortality did not differ between the two groups (31.2% vs. 28.9%, p=0.82). Hospital length of stay was significantly shorter in the methylprednisolone group (24 days [IQR:15-41 days] vs. 37 days [IQR:23-52 days], p=0.046). The incidence of positive blood cultures was higher in patients who received methylprednisolone (37.5% vs. 17.8%, p=0.052). However, 91% of patients who received methylprednisolone also received tocilizumab. The number of days with hyperglycemia was similar in the two groups. Conclusions: Methylprednisolone was independently associated with increased VFDs and shortened hospital length of stay. The combination of methylprednisolone and tocilizumab was associated with a higher rate of positive blood cultures. Further trials are needed to evaluate the benefits and safety of methylprednisolone in moderate or severe COVID-19 ARDS.

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