J. Reid, M. Kho, C. Methods Centre and Investigators
{"title":"CYCLE RCT Participant Retention During the Pandemic: Assessing Protocol Fidelity","authors":"J. Reid, M. Kho, C. Methods Centre and Investigators","doi":"10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2577","DOIUrl":"https://doi.org/10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2577","url":null,"abstract":"Introduction: CYCLE (NCT03471247) is the largest international randomized controlled trial (RCT) of early in-bed cycling with mechanically ventilated patients in the world. It relies on ICU physical therapists for in-person intervention delivery, acute care therapists (including physical and occupational therapists, and therapy assistants) for primary outcomes assessments, and research coordinators (RCs) for 90-day telephone followup. Like many studies, CYCLE recruitment was abruptly interrupted by the COVID-19 pandemic, posing immediate threats to study internal validity. Amidst much uncertainty, we aimed to honor our research commitment to those enrolled before the pandemic. Methods: On March 17, 2020, the province of Ontario declared a state of emergency. Most participating CYCLE institutions halted enrolment to non-COVID research activities. We conducted a cross-sectional standardized email survey to determine the number of patients currently enrolled in the ICU or hospital and the status of patients pending 90-day assessment up to April 30, 2020. We assessed protocol fidelity in the following ways: For patients in ICU, we documented any attempt to provide the randomized intervention. For patients in hospital, we documented any attempt for physical outcomes assessments, prioritizing the primary outcome. For patients discharged from hospital, we documented whether a 90-day phone call was attempted. We also sought feedback to address needs identified by RCs to complete 90-day follow-up remotely. Results: As of March 17, 2020, we enrolled 197 patients in CYCLE overall, and 24 (12.2%) were in hospital or pending 90-day follow-up by April 30. From 15 active sites (12 Canada, 2 US, 1 Australia), 11 (73%) had 24 unique patients of immediate concern (4 ICU, 9 hospital, 16 for 90-day follow-up). All ICU (4/4) interventions and all 90-day calls (17/17) were attempted. Of hospital outcomes assessments, 89% (8/9) were attempted. One site could not complete primary outcomes assessment in hospital due to institutional pandemic policy. We developed guidance to conduct remote 90-day follow up calls from RC personal phones, considering study integrity, and patient and staff confidentiality. Conclusions: We used methodologically rigorous, time-sensitive strategies to address uncertainty during the first wave of the pandemic. We successfully retained almost all patients of immediate concern during the initial period of COVID-19. Protocol fidelity and cohort retention will be important considerations for all trials interrupted by the COVID-19 pandemic. Proactive strategies, learned from the first wave, will be critical as non-COVID research resumes.","PeriodicalId":388725,"journal":{"name":"TP50. TP050 COVID: NONPULMONARY CRITICAL CARE, MECHANICAL VENTILATION, BEHAVIORAL SCIENCES, AND EPI","volume":"35 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131589779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enteral Methadone for Iatrogenic Opioid Withdrawal in Patients with COVID-19 Acute Respiratory Distress Syndrome: A Case Series","authors":"M. Weiss, H. Swoboda, E. Chen","doi":"10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2613","DOIUrl":"https://doi.org/10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2613","url":null,"abstract":"Rationale: Patients with severe acute respiratory distress syndrome (ARDS) often require deep sedation for extended periods of time to facilitate mechanical ventilation. The emergence of COVID-19 resulted in high volume of patients admitted to our tertiary care center with severe ARDS. Many developed withdrawal symptoms upon tapering of continuous sedation and were unable to be safely extubated despite improved ventilator requirements. A protocol using enteral methadone was developed to facilitate tapering of continuous sedation and mitigate the severity of iatrogenic withdrawal. Methods: Data was collected through retrospective chart review of patients treated with protocolized methadone for IWS during 04/2020-08/2020. Inclusion criteria were FiO2 ≤ 60%, PEEP ≤ 12cmH220, ≥ 5 days of continuous fentanyl or hydromorphone (≥100 mcg/hr or 1.5 mg/hr respectively), and approval by the toxicology and addiction medicine service. Those receiving high dose vasopressors, paralytics, or QTc ≥500ms were excluded. Descriptive statistics after initiation of methadone are presented in the following case series. Results: There were 32 patients treated with methadone for IWS during the study period. Of these participants, 90% were male (N=29) with median age of 59 (IQR 52-63.5). Opioid infusions were successfully weaned in 75% of patients (N=24) treated with methadone. Median time to wean continuous opioids after starting methadone was 2.5 days (mean 4.08, IQR 1-5). At the end of the study period, 40% (N=13) of patients died from complications of COVID-19. Of the patients who survived, 7 required tracheostomy placement and 16 were successfully extubated. One patient developed prolonged QT with ectopy and was switched to IV Buprenorphine. She was subsequently weaned off continuous sedation after 5 days. Another patient developed prolonged QT but was able to resume after holding for 48 hours. Conclusion: IWS is a barrier to de-escalation of care in patients with COVID-19 ARDS. IWS is associated with longer ICU stay and duration of mechanical ventilation. Protocolized methadone use can be an effective tool for mitigating IWS as suggested by the findings in this study. This study is limited by the lack of a control group. Future directions include comparison to a matched cohort of patients not treated with methadone. Continued investigation with prospective studies in the context of changing practice guidelines for COVID-19 are also warranted. If methadone is found to be safe and effective in future studies, widespread use could help reduce the strain on ICU resources by COVID-19.","PeriodicalId":388725,"journal":{"name":"TP50. TP050 COVID: NONPULMONARY CRITICAL CARE, MECHANICAL VENTILATION, BEHAVIORAL SCIENCES, AND EPI","volume":"71 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117183036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
V. Sueblinvong, M. J. Kaalla, A. Mehta, B. Emory COVID-19 Quality and Clinical Research Colla
{"title":"COVID-19 and Blood Type in Atlanta","authors":"V. Sueblinvong, M. J. Kaalla, A. Mehta, B. Emory COVID-19 Quality and Clinical Research Colla","doi":"10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2595","DOIUrl":"https://doi.org/10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2595","url":null,"abstract":"Introduction: The purpose of this study was to determine if there are any associations with severity of illness from Coronavirus disease 2019 (COVID-19) and ABO blood group among a cohort of critically ill patients admitted to the intensive care unit across the Emory Healthcare System. Since COVID-19 was first identified, many research groups across the country have worked to identify potential risk factors for the development of severe disease. Specifically, there have been some reports of a possible association between blood type A and a higher risk of infection and mortality, while other groups have determined that no such association exists. We sought to determine if ABO blood group was associated with higher rates of intubation, mortality, or inflammatory markers at our institution. Methods: We analyzed data from the electronic medical record (EMR) of all patients who were admitted to the hospital with COVID-19 at any of the Emory Hospitals between March 6, 2020 and May 5, 2020. The data were collected by the Emory COVID-19 Quality and Clinical Research Collaborative, and we included and analyzed data from patients who had data available for blood group and spent any time in the intensive care unit during their hospitalization. We used the Chi-square test to determine if death or intubation were associated with blood group and ANOVA when comparing inflammatory markers between the blood groups. Results: A total of 192 patients in the cohort had data available for blood type and among them 47 patients had blood group A (24.5%) vs 42% nationally, 48 had blood group B (25.0%) vs 10%, 9 had blood group AB (4.7%) vs 4%, and 88 had blood group O (45.8%) vs 44%. Death and intubation were not associated with any blood group type (p=0.424 and p=0.144, respectively). Values for inflammatory markers (CRP, IL-6, D-dimer, WBC, and ferritin) were not significantly different between the different blood groups (p=0.654, p=0.357, p=0.060, p=0.083, and p=0.706, respectively). Conclusions: When compared to data from the American Red Cross, blood group B was more prevalent in our cohort compared to the general population of the US. There was no association between blood group type and death or mechanical ventilation. We noted a trend towards higher D-dimer levels and WBC counts in patients with blood group B, but overall, there were no significant differences between inflammatory markers and blood group types among critically ill patients with COVID-19.","PeriodicalId":388725,"journal":{"name":"TP50. TP050 COVID: NONPULMONARY CRITICAL CARE, MECHANICAL VENTILATION, BEHAVIORAL SCIENCES, AND EPI","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133613355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
P. Budhathoki, Y. Sedhai, D. Shrestha, R. Baniya, B. D. Pathak, O.P. Tandon, P. Thapa, P. Prasai
{"title":"N-Acetyl Cysteine with Steroid Versus Steroid Alone in Severe Alcoholic Hepatitis: A Systematic Review and Meta-Analysis","authors":"P. Budhathoki, Y. Sedhai, D. Shrestha, R. Baniya, B. D. Pathak, O.P. Tandon, P. Thapa, P. Prasai","doi":"10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2579","DOIUrl":"https://doi.org/10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2579","url":null,"abstract":"","PeriodicalId":388725,"journal":{"name":"TP50. TP050 COVID: NONPULMONARY CRITICAL CARE, MECHANICAL VENTILATION, BEHAVIORAL SCIENCES, AND EPI","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122006113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Shashaty, T. Miano, C. Cosgriff, T. Jones, H. Giannini, O. Oniyide, A. Weisman, C. Ittner, T. Dunn, R. Agyekum, D. Mathew, A. Baxter, K. D’Andrea, E. Wherry, B. J. Anderson, J. Reilly, N. Meyer
{"title":"Plasma Resistin Levels Are Associated with Acute Kidney Injury in Hospitalized COVID-19 Patients","authors":"M. Shashaty, T. Miano, C. Cosgriff, T. Jones, H. Giannini, O. Oniyide, A. Weisman, C. Ittner, T. Dunn, R. Agyekum, D. Mathew, A. Baxter, K. D’Andrea, E. Wherry, B. J. Anderson, J. Reilly, N. Meyer","doi":"10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2571","DOIUrl":"https://doi.org/10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2571","url":null,"abstract":"Rationale: Obesity is a strong risk factor for acute kidney injury (AKI) in patients with COVID-19, but underlying mechanisms are unknown. Resistin is an immunomodulatory adipokine with elevated circulating levels in obese outpatients that could contribute to inflammatory kidney injury. We hypothesized that plasma resistin levels would be associated with AKI and BMI, and correlated with the inflammatory markers IL6 and MCP1 in hospitalized COVID-19 patients. Methods: We conducted a prospective cohort study of 134 patients admitted to the Hospital of the University of Pennsylvania with a primary diagnosis of COVID-19. Plasma samples were collected within 48 hours of admission and analyzed using the Olink Proximity Extension Assay, with biomarker levels expressed using normalized protein expression (NPX) values relative to common pooled control plasma. We tested the association of each biomarker with AKI, defined by Kidney Disease Improving Global Outcomes creatinine and dialysis criteria, using the Wilcoxon rank-sum test as well as multivariable logistic regression to adjust for confounders. Spearman's rho and correlation coefficients were calculated for the correlation of biomarker levels with each other. We used causal mediation models to investigate effects of BMI on AKI mediated by plasma resistin. Results: Of 134 patients enrolled, 43 (32.1%) developed AKI: 25 with stage 1, 5 with stage 2, and 13 with stage 3. Plasma resistin levels ranged from 5.26-13.01 NPX units and were strongly associated with AKI: odds ratio 2.13 (95% CI 1.43-3.17) per NPX unit. This association was diminished but remained significant after adjustment for age and APACHE III score (OR 1.69 (1.09-2.63)). Body mass index was higher in patients with AKI than without (median 31.4 (IQR 27.1-37.6) kg/m2 v. 28.3 (25.1-34.9) kg/m2, respectively), but the difference was not statistically significant (p=0.082). There was no significant correlation of BMI with resistin levels (rho 0.05, p=0.562), and causal mediation models failed to detect significant mediation of BMI-AKI association through resistin. Plasma IL6 and MCP1 were associated with AKI (p=0.044 and p=0.003, respectively) and correlated with resistin levels (rho=0.32, p<0.001 and rho=0.40, p<0.001, respectively). Conclusion: In patients hospitalized with COVID-19, plasma levels of the adipokine resistin were strongly associated with the development of AKI, and correlated with circulating inflammatory markers IL6 and MCP1. We did not detect a mediation effect of the obesity-AKI association by plasma resistin but had limited sample size to adequately power this analysis.","PeriodicalId":388725,"journal":{"name":"TP50. TP050 COVID: NONPULMONARY CRITICAL CARE, MECHANICAL VENTILATION, BEHAVIORAL SCIENCES, AND EPI","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125683498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
F. Laghi, M. Saad, J. Brofman, N. Undevia, H. Shaikh
{"title":"Long-Term Acute Care Hospital Outcomes of Mechanically Ventilated and Non-Ventilated Patients with COVID-19","authors":"F. Laghi, M. Saad, J. Brofman, N. Undevia, H. Shaikh","doi":"10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2618","DOIUrl":"https://doi.org/10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a2618","url":null,"abstract":"Background: Patients with coronavirus disease 2019 (COVID-19) and respiratory failure requiring invasive or non-invasive ventilation in acute care hospitals are commonly transferred to long-term acute care hospitals (LTACHs). Data on the clinical characteristics and outcomes of these patients is lacking. Objectives: To describe for the first-time clinical characteristics and outcomes of a cohort of patients with COVID-19 and respiratory failure requiring invasive or non-invasive mechanical ventilation transferred to two Chicago-area LTACHs. Methods: From April 17, 2020 to June 30, 2020, fifteen COVID-19 patients who had been liberated from mechanical ventilation at the acute care hospital were transferred to the LTACHs. These patients were matched with 14 COVID-19 patients transferred to the same LTACHs for weaning from prolonged invasive ventilation. Demographic, clinical, and laboratory data were collected and analyzed. Final date of follow-up was December 20, 2020. Results: The median (interquartile range) age of non-mechanically ventilated (non-MV) patients at LTACH admission was 63.0 years (55.0-74.0);7 (46.7%) patients were women and 8 (53.3%) resided in low-income areas. The corresponding values in patients mechanically ventilated (MV) at LTACH admission were 64.0 years (58.0-73.3), 6 (42.9%) women and 8 (57.1%) resided in low-income areas. Race distribution, premorbid functional status (Zubrod score), premorbid clinical characteristics (Charlson Comorbidity Index), and severity of disease at LTACH admission (APACHE II) were equivalent in the two groups of patients. The most common indications for LTACH transfer in the non-MV group were tracheostomy decannulation (60.0%), weaning from high-flow oxygen (40%) and delirium/encephalopathy (33.3%). The corresponding indications in the MV group were weaning from invasive ventilation (100%), prolonged antibiotic therapy (42.9%) and delirium/encephalopathy (14.3%). No patient in the non-MV group required mechanical ventilation during LTACH stay, 7 of 9 (77.8%) with a tracheostomy were decannulated and 1 (6.7%) died. In the MV group, 13 (92.9%) were successfully weaned, and 6 (42.9%) were decannulated and none died. Five (33.3%) patients in the non-MV group and 2 (15.4%, p=0.396) in the MV group were discharged home. The remaining were transferred to a rehabilitation facility, nursing home or acute care hospital. One patient in the MV group remains in the LTACH. Conclusion: Irrespective of mechanical ventilation status at LTACH admission, most COVID-19 patients survived LTACH admission, yet the majority were not discharged home but required ongoing inpatient medical care.","PeriodicalId":388725,"journal":{"name":"TP50. TP050 COVID: NONPULMONARY CRITICAL CARE, MECHANICAL VENTILATION, BEHAVIORAL SCIENCES, AND EPI","volume":"203 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121631165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}