Dataset Information

Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.

ABSTRACT: To evaluate safety and clinical outcomes of extracorporeal immunomodulation treatment with a selective cytopheretic device (SCD) in COVID-19 ICU patients with multiple organ failure.

Design

Two-center, prospective, single-arm treatment clinical trial.

Setting

ICUs at two academic medical centers between September 2020 and July 2021.

Patients

Twenty-two COVID-10 patients in the ICU with acute respiratory distress syndrome who required mechanical ventilation. Nearly all included patients in the intervention group except one had acute kidney injury requiring continuous renal replacement therapy (CRRT). Sixteen subjects meeting enrollment criteria were selected as contemporaneous controls from a concurrent prospective registry CRRT trial.

Intervention

Treatment with an SCD integrated into a continuous renal replacement extracorporeal blood circuit for up to 10 days to provide autologous leukocyte cell processing to immunomodulate the hyperinflammatory disease state of COVID-19.

Measurements and main results

SCD treatment in COVID-19 ICU patients with multiple organ failure demonstrated an acceptable safety profile with no device-related serious adverse events. Treatment of these patients resulted in the selective removal of highly activated circulating leukocytes as determined by flow cytometry. Significant reductions were observed in the elevated plasma levels of eight cytokines and biomarkers, including interleukin (IL)6, IL15, IL10, and soluble ST2, which are predictive of mortality in COVID-19 patients. Significant improvements of leukocytosis and Po₂/Fio₂ ratios occurred during treatment not observed in the control group. SCD-treated subjects had a reduction in 60-day mortality of 50% compared with 81% in the control cohort. The subjects who received greater than 96 hours of SCD treatment, per protocol, had a further reduction in mortality to 31% (p < 0.012).

Conclusions

Extracorporeal immunomodulation therapy with an SCD demonstrated safety without any device-related serious adverse events. As a rescue therapy in COVID-19 ICU patients progressing to multiple organ failure despite maximal pharmacologic and organ support interventions, SCD treatment resulted in improved clinical outcomes. This autologous leukocyte cell processing technology may provide a new approach in the treatment of unremitting hyperinflammation of COVID-19.

SUBMITTER: Yessayan LT

PROVIDER: S-EPMC9126516 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.

Yessayan Lenar T LT Neyra Javier A JA Westover Angela J AJ Szamosfalvi Balazs B Humes H David HD

Critical care explorations 20220519 5

To evaluate safety and clinical outcomes of extracorporeal immunomodulation treatment with a selective cytopheretic device (SCD) in COVID-19 ICU patients with multiple organ failure.<h4>Design</h4>Two-center, prospective, single-arm treatment clinical trial.<h4>Setting</h4>ICUs at two academic medical centers between September 2020 and July 2021.<h4>Patients</h4>Twenty-two COVID-10 patients in the ICU with acute respiratory distress syndrome who required mechanical ventilation. Nearly all includ ...[more]

PMID: 35620768

Similar Datasets

Project description:BackgroundThe COVID-19 pandemic remains an immediate and present concern, yet as of now there is still no approved therapeutic available for the treatment of COVID-19.This study aimed to investigate and report evidence concerning demographic characteristics and currently-used medications that contribute to the ultimate outcomes of COVID-19 ICU patients.MethodsA retrospective cohort study was conducted among all COVID-19 patients in the Intensive Care Unit (ICU) of Asir Central Hospital in Saudi Arabia between the 1st and 30th of June 2020. Data extracted from patients' medical records included their demographics, home medications, medications used to treat COVID-19, treatment durations, ICU stay, hospital stay, and ultimate outcome (recovery or death).Descriptive statistics and regression modelling were used to analyze and compare the results. The study was approved by the Institutional Ethics Committees at both Asir Central Hospital and King Khalid University.ResultsA total of 118 patients with median age of 57 years having definite clinical and disease outcomes were included in the study. Male patients accounted for 87% of the study population, and more than 65% experienced at least one comorbidity. The mean hospital and ICU stay was 11.4 and 9.8 days, respectively. The most common drugs used were tocilizumab (31.4%), triple combination therapy (45.8%), favipiravir (56.8%), dexamethasone (86.7%), and enoxaparin (83%). Treatment with enoxaparin significantly reduced the length of ICU stay (p = 0.04) and was found to be associated with mortality reduction in patients aged 50-75 (p = 0.03), whereas the triple regimen therapy and tocilizumab significantly increased the length of ICU stay in all patients (p = 0.01, p = 0.02 respectively).ConclusionCOVID-19 tends to affect males more significantly than females. The use of enoxaparin is an important part of COVID-19 treatment, especially for those above 50 years of age, while the use of triple combination therapy and tocilizumab in COVID-19 protocols should be reevaluated and restricted to patients who have high likelihood of benefit.

Project description:BackgroundCOVID-19 has led to significant hospitalization and intensive care unit admission rates. The demographic parameters of COVID-19 patients, such as age, underlying illnesses, and clinical symptoms, substantially influence the incidence and mortality of these individuals. The current study examined the clinical and demographic characteristics of COVID-19 intensive care unit (ICU) patients in Yazd, Iran.MethodsThe descriptive-analytical cross-sectional study was conducted on ICU patients with a positive RT-PCR test for coronavirus, admitted to the ICU in Yazd province, Iran, over 18 months. To this end, demographic, clinical, laboratory, and imaging data were collected. Moreover, patients were divided into good and worse clinical outcome groups based on their clinical outcomes. Subsequently, data analysis was performed at a 95% confidence interval (CI) using SPSS 26 software.Results391 patients with positive PCR were analyzed. The average age of the patients in the study was 63.59 ± 17.76, where 57.3% were male. On the high-resolution computed tomography (HRCT) scan, the mean lung involvement score was 14.03 ± 6.04, where alveolar consolidation (34%) and ground-glass opacity (25.6%) were the most prevalent type of lung involvement. The most common underlying illnesses in the study participants were hypertension (HTN) (41.4%), diabetes mellitus (DM) (39.9%), ischemic heart disease (IHD) (21%), and chronic kidney disease (CKD) (20.7%). In hospitalized patients, the rates of endotracheal intubation and mortality were 38.9% and 38.1%, respectively. Age, DM, HTN, dyslipidemia, CKD, cerebral vascular accident (CVA), cerebral hemorrhage, and cancer were reported to be significantly different between these two groups of patients, indicating an increase in the rate of intubation and mortality among these patients. Furthermore, the multivariate logistic regression analysis revealed that DM, HTN, CKD, CVA, neutrophil-to-lymphocyte ratio (NLR), the percentage of lung involvement, and initial O2 saturation significantly increase the mortality of ICU patients.ConclusionSeveral features of COVID-19 patients influence the mortality in these individuals. According to the findings, early detection of this disease in people at high risk of death can prevent its progression and lower mortality rates.

Dataset Information

Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.

Design

Setting

Patients

Intervention

Measurements and main results

Conclusions

Publications

Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets