scholarly journals 71. Use of Intravenous Immunoglobulin Therapy Reduces Progression to Mechanical Ventilation in COVID-19 Patients with Moderate to Severe Hypoxia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S166-S166
Author(s):  
George Sakoulas ◽  
Matthew Geriak ◽  
Ravina Kullar ◽  
Kris Greenwood ◽  
Mackenzie Habib ◽  
...  

Abstract Background The majority of COVID-19 morbidity and mortality occurs in patients who progress to mechanical ventilation. Therefore, therapeutic interventions targeting the mitigation of this complication would markedly improve outcomes and reduce healthcare utilization. Methods Patients with COVID-19 from two hospitals in San Diego, California were randomized at a 1:1 ratio to receive standard of care (SOC) plus intravenous immunoglobulin (IVIG) at 0.5 g/kg/day x 3 days with solumedrol 40 mg 30 minutes before infusion (IVIG group) versus SOC alone. The primary composite endpoint was receipt of mechanical ventilation or death before receiving ventilation. Patients were followed until discharge to home or up to 30 days from time of enrollment. Results Sixteen patients received IVIG plus SOC and 17 SOC alone. The median age was 54 years for SOC and 57 years for IVIG. Median time from hospital admission to study enrollment was 1 day (range 0–4) for SOC and 2 days (range 0–8) for IVIG. APACHE II scores and Charlson comorbidity indices were similar for IVIG and SOC (median 8 vs 7 and 2 for both, respectively). Seven SOC patients achieved the composite endpoint (6 ventilated, 1 death) versus 2 IVIG patients (2 ventilated), p=0.12, Fisher exact test. Among the subgroup with an estimated A-a gradient of >200 mm Hg at time of enrollment, the IVIG group showed a lower rate of progression to the composite endpoint (2/14 vs 7/12, p=0.04 Fisher exact test), shorter median hospital length (11 vs 24 days, p=0.001 Mann Whitney U), and shorter median intensive care unit (ICU) stay (3 vs 13 days, p=0.005 Mann Whitey U). Conclusion This small, prospective, randomized, open-label study showed that when administered to hypoxic non-ventilated COVID-19 patients with an A-a gradient of >200 mm Hg (corresponding to a requirement of 6 liters O2 via nasal cannula to achieve an SpO2 of 92%), IVIG significantly decreased the rates of progression to mechanical ventilation, ICU length of stay, and total hospital length of stay. A Phase 3 prospective, randomized, placebo-controlled, multicenter trial is underway to further validate these findings. Disclosures George Sakoulas, MD, Octapharma (Grant/Research Support, Scientific Research Study Investigator)

Author(s):  
George Sakoulas ◽  
Matthew Geriak ◽  
Ravina Kullar ◽  
Kristina Greenwood ◽  
MacKenzie Habib ◽  
...  

Background. Interventions mitigating progression to mechanical ventilation in COVID-19 would markedly improve outcome and reduce healthcare utilization. We hypothesized that immunomodulation with IVIG would improve oxygenation and reduce length of hospital stay and progression to mechanical ventilation in COVID-19 pneumonia. Methods. Patients with COVID-19 were randomized 1:1 to prospectively receive standard of care (SOC) plus intravenous immunoglobulin (IVIG) 0.5 g/kg/day x 3 days with methylprednisolone 40 mg 30 minutes before infusion versus SOC alone. Results. 16 subjects received IVIG plus SOC and 17 SOC alone. The median age was 51 years for SOC and 58 years for IVIG. APACHE II scores and Charlson comorbidity indices were similar for IVIG and SOC (median 7.5 vs 7 and 2 for both, respectively). Seven SOC versus 2 IVIG subjects required mechanical ventilation (p=0.12, Fisher exact test). Among subjects with A-a gradient of >200 mm Hg at enrollment, the IVIG group showed i) a lower rate of progression to requiring mechanical ventilation (2/14 vs 7/12, p=0.038 Fisher exact test), ii) shorter median hospital length of stay (11 vs 19 days, p=0.01 Mann Whitney U), iii) shorter median ICU stay (2.5 vs 12.5 days, p=0.006 Mann Whitey U), and iv) greater improvement in PaO2/FiO2 at 7 days (median [range] change from time of enrollment +131 [+35 to +330] vs +44.5 [-115 to +157], p=0.01, Mann Whitney-U test) than SOC. Conclusion. This pilot prospective randomized study comprising largely of Latino patients showed that IVIG significantly improved hypoxia and reduced hospital length of stay and progression to mechanical ventilation in COVID-19 patients with A-a gradient >200 mm Hg.


Author(s):  
Brady S Moffett ◽  
Soyoon Lee ◽  
Kristen Woodend ◽  
Binayak Sigdel ◽  
Ankhi Dutta

Abstract Background Management of pediatric drowning often includes evaluation and treatment of infectious disease. There are few data describing the infections associated with pediatric drowning. Methods A descriptive retrospective study was designed, and patients aged < 19 years admitted for > 24 hours to our institution after a drowning were included from January 2011 through June 30, 2017. Data collection included patient demographics, submersion injury details, resuscitation details, patient admission details, chest radiograph on admission, use of intubation and mechanical ventilation, hospital length of stay, culture data, antimicrobial use, and mortality. Descriptive statistical methods (mean and standard deviation, median and range, percentage) were used to characterize the patient population, and Fisher exact test was used to evaluate the association between antimicrobial use in the first 72 hours of admission and mortality. Results A total of 114 patients met study criteria (male, 59.7%; median age, 3.7 years [range, 0.15–17.79 years]). Median hospital length of stay was 2 days (range, 1–60 days). Intensive care unit admission occurred in 80.7%, intubation occurred in 46.5%, and mortality was 18.4%. The most common submersion location was a pool (76.3% [n = 87]) with water primarily characterized as freshwater (82.5% [n = 94]). Reported submersion time for the majority of patients was < 5 minutes (54.4%) with cardiopulmonary resuscitation in 78.1%. In the first 72 hours after admission, culture were obtained in 40 patients (35.1%), and 27.5% of these cultures were positive. The primary organisms identified were consistent oropharyngeal flora. Antimicrobials were initiated in 50% of the patient population with clindamycin as most common. There was not a significant association between antimicrobial use in the first 72 hours after admission and mortality (17.2% vs 19.6%, P = .81). Conclusions Infectious disease associated with pediatric drowning in pools is uncommon. Empiric use of antimicrobials does not appear to affect outcomes.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S346-S346
Author(s):  
Sarah Norman ◽  
Sara Jones ◽  
David Reeves ◽  
Christian Cheatham

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)


Neurosurgery ◽  
2020 ◽  
Author(s):  
Nitin Agarwal ◽  
Ezequiel Goldschmidt ◽  
Tavis Taylor ◽  
Souvik Roy ◽  
Stefanie C Altieri Dunn ◽  
...  

Abstract BACKGROUND With an aging population, elderly patients with multiple comorbidities are more frequently undergoing spine surgery and may be at increased risk for complications. Objective measurement of frailty may predict the incidence of postoperative adverse events. OBJECTIVE To investigate the associations between preoperative frailty and postoperative spine surgery outcomes including mortality, length of stay, readmission, surgical site infection, and venous thromboembolic disease. METHODS As part of a system-wide quality improvement initiative, frailty assessment was added to the routine assessment of patients considering spine surgery beginning in July 2016. Frailty was assessed with the Risk Analysis Index (RAI), and patients were categorized as nonfrail (RAI 0-29) or prefrail/frail (RAI ≥ 30). Comparisons between nonfrail and prefrail/frail patients were analyzed using Fisher's exact test for categorical data or by Wilcoxon rank sum tests for continuous data. RESULTS From August 2016 through September 2018, 668 patients (age of 59.5 ± 13.3 yr) had a preoperative RAI score recorded and underwent scheduled spine surgery. Prefrail and frail patients suffered comparatively higher rates of mortality at 90 d (1.9% vs 0.2%, P < .05) and 1 yr (5.1% vs 1.2%, P < .01) from the procedure date. They also had longer in-hospital length of stay (LOS) (3.9 d ± 3.6 vs 3.1 d ± 2.8, P < .001) and higher rates of 60 d (14.6% vs 8.2%, P < .05) and 90 d (15.8% vs 9.8%, P < .05) readmissions. CONCLUSION Preoperative frailty, as measured by the RAI, was associated with an increased risk of readmission and 90-d and 1-yr mortality following spine surgery. The RAI can be used to stratify spine patients and inform preoperative surgical decision making.


Author(s):  
Mohamed Badr ◽  
Bruno De Oliveira ◽  
Khaled Abdallah ◽  
Ashraf Nadeem ◽  
Yeldho Varghese ◽  
...  

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’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.


2020 ◽  
Author(s):  
Ana J. Pinto ◽  
Karla F. Goessler ◽  
Alan L. Fernandes ◽  
Igor H. Murai ◽  
Lucas P. Sales ◽  
...  

AbstractPurposeThis small-scale, prospective cohort study nested within a randomized controlled trial aimed to investigate the possible associations between physical activity levels and clinical outcomes among hospitalized patients with severe COVID-19.MethodsHospitalized patients with severe COVID-19 were recruited from Clinical Hospital of the School of Medicine of the University of Sao Paulo (a quaternary referral teaching hospital), and from Ibirapuera Field Hospital, both located in Sao Paulo, Brazil. Physical activity levels were assessed by Baecke Questionnaire of Habitual Physical Activity. The primary outcome was hospital length of stay. The secondary outcomes were: mortality, admission to the intensive care unit (ICU), and mechanical ventilation requirement.ResultsMean hospital length of stay was 8.5 ± 7.1 days; 3.3% of patients died, 13.8% were admitted to ICU, and 8.6% required mechanical ventilation. Linear regression models showed that physical activity indexes were not associated with hospital length of stay (work index: β=-0.57 [95%CI: −1.80 to 0.65], p=0.355; sport index: β=0.43 [95%CI: −0.94 to 1.80], p=0.536; leisure-time index: β=1.18 [95%CI: −0.22 to 2.59], p=0.099; total activity index: β=0.20 [95%CI: −0.48 to 0.87], p=0.563. Physical activity indexes were not associated with mortality, admission to ICU and mechanical ventilation requirement (all p>0.05).ConclusionsAmong hospitalized patients with COVID-19, physical activity did not associate with hospital length of stay or any other clinically-relevant outcomes. These findings suggest that previous physical activity levels may not change the prognosis of severe COVID-19.


Children ◽  
2021 ◽  
Vol 8 (5) ◽  
pp. 348
Author(s):  
Nataly Shildt ◽  
Chani Traube ◽  
Mary Dealmeida ◽  
Ishaan Dave ◽  
Scott Gillespie ◽  
...  

We sought to evaluate the success rate of a benzodiazepine-sparing analgosedation protocol (ASP) in mechanically ventilated children and determine the effect of compliance with ASP on in-hospital outcome measures. In this single center study from a quaternary pediatric intensive care unit, our objective was to evaluate the ASP protocol, which included opiate and dexmedetomidine infusions and was used as first-line sedation for all intubated patients. In this study we included 424 patients. Sixty-nine percent (n = 293) were successfully sedated with the ASP. Thirty-one percent (n = 131) deviated from the ASP and received benzodiazepine infusions. Children sedated with the ASP had decrease in opiate withdrawal (OR 0.16, 0.08–0.32), decreased duration of mechanical ventilation (adjusted mean duration 1.81 vs. 3.39 days, p = 0.018), and decreased PICU length of stay (adjusted mean 3.15 vs. 4.7 days, p = 0.011), when compared to the cohort of children who received continuous benzodiazepine infusions. Using ASP, we report that 69% of mechanically ventilated children were successfully managed with no requirement for continuous benzodiazepine infusions. The 69% who were successfully managed with ASP included infants, severely ill patients, and children with chromosomal disorders and developmental disabilities. Use of ASP was associated with decreased need for methadone use, decreased duration of mechanical ventilation, and decreased ICU and hospital length of stay.


2019 ◽  
Vol 85 (10) ◽  
pp. 1194-1197
Author(s):  
Ino Chough ◽  
Karen Zaghiyan ◽  
Gayane Ovsepyan ◽  
Phillip Fleshner

Minimally invasive approaches to total abdominal colectomy (TAC) in ulcerative colitis (UC) patients include straight laparoscopy (SL), hand-assisted laparoscopic surgery (HALS), and robotics. In this study, short-term outcomes of patients undergoing SL and HALS TAC were compared. Prospectively collected data on UC patients undergoing TAC were tabulated. The study cohort included 36 (27%) patients in the SL group and 95 (73%) patients in the HALS group. The groups were comparable in terms of preoperative characteristics and demographics. The mean operative time was 151 (range, 73–225) minutes in the SL group versus 164 (range, 103–295) minutes in the HALS group ( P = 0.09). Total 48-hour IV morphine use was 30 (range, 0–186) mg in the SL group compared with 56 (0–275) mg in the HALS group ( P < 0.01). Although overall morbidity was comparable between the groups, Clavien-Dindo Class III complications did not occur in any of the SL group patients versus 11 (11%) of the HALS group patients ( P = 0.03). The postoperative length of stay was 3 (3–21) days in the SL group versus 5 (3–15) days in the HALS group ( P < 0.01). Compared with HALS, SL is associated with lower postoperative narcotic use and hospital length of stay in UC patients undergoing TAC.


2021 ◽  
Vol 9 ◽  
pp. 205031212110308
Author(s):  
Santiago Cegarra Garcia ◽  
Michael Toolis ◽  
Max Ubels ◽  
Taha Mollah ◽  
Eldho Paul ◽  
...  

Objectives: To compare the characteristics and outcomes of patients presenting to hospital with alcohol-induced and gallstone-induced acute pancreatitis. Methods: Retrospective study of all patients with alcohol-induced or gallstone-induced pancreatitis during the period 1 June 2012 to 31 May 2016. The primary outcome measure was hospital mortality. Secondary outcome measures included hospital length of stay, requirements for intensive care unit admission, intensive care unit mortality, mechanical ventilation, renal replacement therapy, requirement of inotropes and total parenteral nutrition. Results: A total of 642 consecutive patients (49% alcohol; 51% gallstone) were included. No statistically significant differences were found between alcohol-induced and gallstone-induced acute pancreatitis with respect to hospital mortality, requirement for intensive care unit admission, intensive care unit mortality and requirement for mechanical ventilation, renal replacement therapy, inotropes or total parenteral nutrition. There was significant difference in hospital length of stay (3.07 versus 4.84; p  < 0.0001). On multivariable regression analysis, Bedside Index of Severity in Acute Pancreatitis score (estimate: 0.393; standard error: 0.058; p < 0.0001) and admission haematocrit (estimate: 0.025; standard error: 0.008; p = 0.002) were found to be independently associated with prolonged hospital length of stay. Conclusion: Hospital mortality did not differ between patients with alcohol-induced and gallstone-induced acute pancreatitis. The duration of hospital stay was longer with gallstone-induced pancreatitis. Bedside Index of Severity in Acute Pancreatitis score and admission haematocrit were independently associated with hospital length of stay.


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