scholarly journals Intravenous Immunoglobulin (IVIG) Significantly Reduces Respiratory Morbidity in COVID-19 Pneumonia: A Prospective Randomized Trial

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.

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):  
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.


2018 ◽  
Vol 100 (7) ◽  
pp. 556-562 ◽  
Author(s):  
T Richards ◽  
A Glendenning ◽  
D Benson ◽  
S Alexander ◽  
S Thati

Introduction Management of hip fractures has evolved over recent years to drive better outcomes including length of hospital stay. We aimed to identify and quantify the effect that patient factors influence acute hospital and total health service length of stay. Methods A retrospective observational study based on National Hip Fracture Database data was conducted from 1 January 2014 to 31 December 2015. A multiple regression analysis of 330 patients was carried out to determine independent factors that affect acute hospital and total hospital length of stay. Results American Society of Anesthesiologists (ASA) grade 3 or above, Abbreviated Mental Test Score (AMTS) less than 8 and poor mobility status were independent factors, significantly increasing length of hospital stay in our population. Acute hospital length of stay can be predicted as 8.9 days longer when AMTS less than 8, 4.2 days longer when ASA grade was 3 or above and 20.4 days longer when unable to mobilise unaided (compared with independently mobile individuals). Other factors including total hip replacement compared with hemiarthroplasty did not independently affect length of stay. Conclusions Our analysis in a representative and generalisable population illustrates the importance of identifying these three patient characteristics in hip fracture patients. When recognised and targeted with orthogeriatric support, the length of hospital stay for these patients can be reduced and overall hip fracture care improved. Screening on admission for ASA grade, AMTS and mobility status allows prediction of length of stay and tailoring of care to match needs.


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)


2018 ◽  
Vol 12 (2) ◽  
pp. 122-128 ◽  
Author(s):  
Kushan D Radadia ◽  
Nicholas J Farber ◽  
Alexandra L Tabakin ◽  
Wei Wang ◽  
Hiren V Patel ◽  
...  

Objective: Alvimopan use has reduced the length of hospital stay in patients undergoing major abdominal surgeries and radical cystectomy. Retroperitoneal lymph node dissection for testicular cancer may be associated with delayed gastrointestinal recovery prolonging hospital length of stay. We evaluate whether alvimopan is associated with enhanced gastrointestinal recovery and shorter hospital length of stay in men undergoing retroperitoneal lymph node dissection for testicular cancer. Materials and methods: From 2010 to 2016, 29 patients underwent open, transperitoneal bilateral template retroperitoneal lymph node dissection. Data for patients who received alvimopan were prospectively collected and compared to a historical cohort of patients who did not receive alvimopan. Primary outcome measures were length of stay and recovery of gastrointestinal function. Descriptive statistics were reported. Time-to-event outcomes were evaluated using cumulative incidence curves and log rank test. Factors associated with length of stay were analyzed for correlation using multiple linear regression. Results: Of 29 men undergoing retroperitoneal lymph node dissection, eight received alvimopan and 21 did not. The two cohorts were well matched, with no significant differences. In the alvimopan cohort compared with those who did not receive alvimopan median time to return of flatus was 2 versus 4 days ( p=0.0002), and median time to first bowel movement was 2.5 versus 5 days ( p=0.046), respectively. Median length of stay in the alvimopan cohort was 4 days versus 6 days in those who did not receive alvimopan ( p=0.074). In adjusted analyses, receipt of alvimopan did not influence length of stay. Conclusion: Alvimopan may facilitate gastrointestinal recovery after retroperitoneal lymph node dissection for testicular cancer. Whether this translates into reduced length of stay needs to be determined by randomized controlled trials using larger cohorts. Level of evidence: 3b.


2015 ◽  
Vol 81 (6) ◽  
pp. 564-568 ◽  
Author(s):  
Zachary F. Williams ◽  
Lindsay M. Bools ◽  
Ashley Adams ◽  
Thomas V. Clancy ◽  
William W. Hope

Leg-threatening injuries present patients and clinicians with the difficult decision to pursue primary amputation or attempt limb salvage. The effects of delayed amputation after failed limb salvage on outcomes, such as prosthetic use and hospital deposition, are unclear. We evaluated the timing of amputations and its effects on outcomes. We retrospectively reviewed all trauma patients undergoing lower extremity amputation from January 1,2000 through December 31, 2010 at a Level 2 trauma center. Patients undergoing early amputation (amputation within 48 hours of admission) were compared with patients undergoing late amputation (amputations >48 hours after admission). Patient demographics, injury specifics, operative characteristics, and outcomes were documented. During the 11-year study period, 43 patients had a lower extremity amputation and 21 had early amputations. The two groups were similar except for a slightly higher Mangled Extremity Severity Score in the early amputation group. Total hospital length of stay significantly differed between groups, with the late amputation group length of stay being nearly twice as long. The late amputation group had significantly more ipsilateral leg complications than the early group (77% vs 15%). There was a trend toward more prosthetic use in the early group (93%vs 57%, P = 0.07). Traumatic lower extremity injuries requiring amputation are rare at our institution (0.3% incidence). Regardless of the amputation timing, most patients were able to obtain a prosthetic. Although the late group had a longer length of hospital stay and more local limb complications, attempted limb salvage still appears to be a viable option for appropriately selected trauma patients.


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.


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