scholarly journals Efficacy and safety of convalescent plasma and intravenous immunoglobulin in critically ill COVID-19 patients. A controlled clinical trial.

2021 ◽  
Author(s):  
Jose Lenin Beltran Gonzalez ◽  
Mario Gonzalez Gamez ◽  
Emmanuel Antonio Mendoza Enciso ◽  
Ramiro Josue Esparza Maldonado ◽  
Daniel Hernandez Palacios ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Critically Ill ◽  
Invasive Mechanical Ventilation ◽  
Controlled Clinical Trial ◽  
Treatment Groups ◽  
Intention To Treat ◽  
Duration Of Hospitalization ◽  
Group 2

Background The proportion of critically ill COVID 19 patients has collapsed hospital care worldwide. The need for alternative therapies for this group of patients is imperative. This study aims to compare the safety and efficacy of convalescent plasma (CP) compared with human immunoglobulin (IVIg) in patients requiring the administration of high oxygen levels or mechanical ventilation. Methods This is a controlled, randomized, open clinical trial of patients with pneumonia secondary to SARS CoV 2 infection, that fulfilled criteria for severe or critical disease. They were randomized in a 1:2 ratio; group 1 was administered IVIg at a dose of 0.3 grams per kilogram of ideal weight, in an 8 hour infusion every 24 hours, for 5 days. Group 2 was administered 200 ml of CP infused in 2 hours, for 2 days. The primary outcomes were duration of hospitalization and mortality at 28 days. Results: One hundred and ninety (190) patients were randomized; 130 to the CP group, and 60 to the IVIg group. Their average age was 58 years (IQR 47 to 72), and most were male (n= 119, 62.6 %). On inclusion, 85.2 % of patients (n=162) were on invasive mechanical ventilation therapy. Overall mortality in all included patients was 53 % (n= 102), with a median follow-up of 14 days (IQI 8 to 26). Mortality at 28 days was 45.2 % (n=86). In the intention to treat analysis, there was no difference between groups neither in mortality on follow up (53.8 vs. 53.3, p =1.0) nor at 28 days (46.2 vs 43 %, p=0.75, Log Rank p = 0.83). Per protocol analysis between treatment groups revealed no difference in mortality throughout hospitalization (51.5 vs 51.4 %, p=1.0) nor after 28 days (42.1 vs 42.87 %, p=0.92 Log Rank p = 0.54). Only 23 patients in the CP group received plasma with detectable anti SARS CoV 2 antibodies. Conclusions: In critically ill patients or on invasive mechanical ventilation for treatment of COVID19, the use of CP is not superior to IVIg in terms of hospitalization duration or mortality. The use of CP is based on complex logistics and requires an assured level of antibodies if used therapeutically. IVIg does not appear to be useful in this group of patients.

scholarly journals Safety and Long-term Improvement of Mesenchymal Stromal Cell Infusion in Critically COVID-19 Patients: A Randomized Clinical Trial.

2021 ◽  
Author(s):  
Carmen Kuniyoshi Rebelatto ◽  
Alexandra Cristina Senegaglia ◽  
Claudio Luciano Franck ◽  
Debora Regina Daga ◽  
Patrícia Shigunov ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Critically Ill ◽  
Adjunctive Therapy ◽  
Invasive Mechanical Ventilation ◽  
Chronic Phase ◽  
Cell Subpopulation ◽  
Regeneration Ability ◽  
Persistent Symptoms

Abstract Background: COVID-19 is a multisystem disease that presents acute and persistent symptoms, the PostAcute Sequelae (PASC). Long-term symptoms may be due to consequences from organ or tissue injury caused by SARS-CoV-2, associated clotting or inflammatory processes during acute COVID-19. Various strategies are being chosen for by clinicians to prevent severe cases of COVID-19; however, a single treatment would not be efficient in treating such a complex disease. Mesenchymal stromal cells (MSCs) are known for their immunomodulatory properties and regeneration ability; therefore, they are a promising tool for treating disorders involving immune dysregulation and extensive tissue damage, as is the case with COVID-19. This study aimed to assess the safety and explore the long-term efficacy of three intravenous doses of UC-MSCs (umbilical cord-MSCs) as an adjunctive therapy in the recovery and postacute sequelae reduction caused by COVID-19. To our knowledge, this is the first report that presents the longest follow-up after MSC treatment in COVID-19 patients. Methods: This was a phase I/II, prospective, single-center, randomized, double-blind, placebo-controlled clinical trial. Seventeen patients diagnosed with COVID-19 who require intensive care surveillance and invasive mechanical ventilation – critically ill patients – were included. The patient infusion was three doses of 5x105 cells/kg UC-MSCs, with a dosing interval of 48 hours (n=11) or placebo (n=6). These evaluations consisted of a clinical assessment, viral load, laboratory testing, including blood count, serologic, biochemical, cell subpopulation, cytokines and CT scan. Results: The results revealed that in the UC-MSC group, there was a reduction in the levels of ferritin, IL-6 and MCP1-CCL2 on the fourteen day. In the second month, a decrease in the levels of reactive C-protein, D-dimer, and neutrophils and an increase in the numbers of TCD3, TCD4 and NK lymphocytes were observed. A decrease in lung extension was observed at the fourth month. The improvement in all these parameters was maintained until the end of patient follow-up. Conclusions: UC-MSCs infusion is safe and can play an important role as an adjunctive therapy, both in the early stages, preventing severe complications and in the chronic phase with postacute sequelae reduction in critically ill COVID-19 patients. Trial registration: Brazilian Registry of Clinical Trials (ReBEC), UTN code - U1111-1254-9819. Registered 31 October 2020 - Retrospectively registered, https://ensaiosclinicos.gov.br/rg/RBR-3fz9yr

scholarly journals Structured ICU resource management in a pandemic is associated with favorable outcome in critically ill COVID‑19 patients

2020 ◽  
Vol 132 (21-22) ◽  
pp. 653-663
Author(s):  
Sebastian J. Klein ◽  
Romuald Bellmann ◽  
Hannes Dejaco ◽  
Stephan Eschertzhuber ◽  
Dietmar Fries ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Intensive Care ◽  
Critically Ill ◽  
Invasive Mechanical Ventilation ◽  
Simplified Acute Physiology Score ◽  
Icu Mortality ◽  
Icu Length Of Stay ◽  
Significant Difference ◽  
Median Hospital

Summary Introduction On February 25, 2020, the first 2 patients were tested positive for severe acute respiratory syndrome coronavirus‑2 (SARS-CoV-2) in Tyrol, Austria. Rapid measures were taken to ensure adequate intensive care unit (ICU) preparedness for a surge of critically ill coronavirus disease-2019 (COVID-19) patients. Methods This cohort study included all COVID-19 patients admitted to an ICU with confirmed or strongly suspected COVID-19 in the State of Tyrol, Austria. Patients were recorded in the Tyrolean COVID-19 intensive care registry. Date of final follow-up was July 17, 2020. Results A total of 106 critically ill patients with COVID-19 were admitted to 1 of 13 ICUs in Tyrol from March 9 to July 17, 2020. Median age was 64 years (interquartile range, IQR 54–74 years) and the majority of patients were male (76 patients, 71.7%). Median simplified acute physiology score III (SAPS III) was 56 points (IQR 49–64 points). The median duration from appearance of first symptoms to ICU admission was 8 days (IQR 5–11 days). Invasive mechanical ventilation was required in 72 patients (67.9%) and 6 patients (5.6%) required extracorporeal membrane oxygenation treatment. Renal replacement therapy was necessary in 21 patients (19.8%). Median ICU length of stay (LOS) was 18 days (IQR 5–31 days), median hospital LOS was 27 days (IQR 13–49 days). The ICU mortality was 21.7% (23 patients), hospital mortality was 22.6%. There was no significant difference in ICU mortality in patients receiving invasive mechanical ventilation and in those not receiving it (18.1% vs. 29.4%, p = 0.284). As of July 17th, 2020, two patients are still hospitalized, one in an ICU, one on a general ward. Conclusion Critically ill COVID-19 patients in Tyrol showed high severity of disease often requiring complex treatment with increased lengths of ICU and hospital stay. Nevertheless, the mortality was found to be remarkably low, which may be attributed to our adaptive surge response providing sufficient ICU resources.

scholarly journals Clinical Outcomes and Independent Risk Factors for 90-day Mortality in Critically-ill Patients Infected With SARS CoV-2: a Multicenter Study in Turkish Intensive Care Units

2021 ◽  
Author(s):  
Kursat Gundogan ◽  
Ismail Hakki Akbudak ◽  
Pervin Hanci ◽  
Burcin Halacli ◽  
Sahin Temel ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mechanical Ventilation ◽  
Critically Ill ◽  
Fluid Balance ◽  
Critically Ill Patients ◽  
Lactate Level ◽  
Invasive Mechanical Ventilation ◽  
Positive Fluid Balance

Abstract Background: There are limited data on long-term outcome and mortality predictors of COVID-19 from different parts of the world. The aim of this study was to determine risk factors of 90-day mortality in critically-ill patients infected with SARS-CoV-2 in Turkish ICUs. Methods: This multicenter, retrospective study was performed in 26 ICUs in Turkey. All patients with confirmed SARS-CoV2 infection, requiring more than 24 hours of ICU follow-up were included in the study. Demographics, clinical characteristics, laboratory variables, respiratory support, treatment types, and survival data were recorded. Results: A total of 421 patients were included in the study. The median age was 67 (IQR: 57-76) years, and 251 patients (59.6%) were men. 90-day mortality rate was 55.1%. Factors independently associated with 90-day mortality were receiving invasive mechanical ventilation (HR 4.09 [95% CI: 2.20-7.63]), admission lactate level > 2 mmol/L (2.78 [1.93-4.01]), age ≥ 60 years (2.45 [1.48-4.06)]), having cardiac arrhythmia during ICU stay (2.01 [1.27-3.20]), receiving vasopressor treatment (1.94 [1.32-2.84]), positive fluid balance of ≥ 600 ml/per day during ICU follow-up (1.68 [1.21-2.34]), admission PaO2/FiO2 ratio of ≤ 150 mmHg (1.66 [1.18-2.32], and baseline ECOG score ≥ 1 (1.42 [1.00-2.02]. Conclusion: This study has shown that long-term mortality was high in critically-ill COVID-19 patients in Turkish ICUs. Invasive mechanical ventilation, high lactate level, older age, presence of cardiac arrhythmia, need for vasopressor treatment, positive fluid balance, severe hypoxemia and not having fully-active performance were related with mortality.

scholarly journals Etiology, incidence, and outcomes of patient–ventilator asynchrony in critically-ill patients undergoing invasive mechanical ventilation

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yongfang Zhou ◽  
Steven R. Holets ◽  
Man Li ◽  
Gustavo A. Cortes-Puentes ◽  
Todd J. Meyer ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mechanical Ventilation ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Invasive Mechanical Ventilation ◽  
Surgical Intensive Care ◽  
Mechanically Ventilated ◽  
History Of ◽  
Training Background ◽  
The Relationship

AbstractPatient–ventilator asynchrony (PVA) is commonly encountered during mechanical ventilation of critically ill patients. Estimates of PVA incidence vary widely. Type, risk factors, and consequences of PVA remain unclear. We aimed to measure the incidence and identify types of PVA, characterize risk factors for development, and explore the relationship between PVA and outcome among critically ill, mechanically ventilated adult patients admitted to medical, surgical, and medical-surgical intensive care units in a large academic institution staffed with varying provider training background. A single center, retrospective cohort study of all adult critically ill patients undergoing invasive mechanical ventilation for ≥ 12 h. A total of 676 patients who underwent 696 episodes of mechanical ventilation were included. Overall PVA occurred in 170 (24%) episodes. Double triggering 92(13%) was most common, followed by flow starvation 73(10%). A history of smoking, and pneumonia, sepsis, or ARDS were risk factors for overall PVA and double triggering (all P < 0.05). Compared with volume targeted ventilation, pressure targeted ventilation decreased the occurrence of events (all P < 0.01). During volume controlled synchronized intermittent mandatory ventilation and pressure targeted ventilation, ventilator settings were associated with the incidence of overall PVA. The number of overall PVA, as well as double triggering and flow starvation specifically, were associated with worse outcomes and fewer hospital-free days (all P < 0.01). Double triggering and flow starvation are the most common PVA among critically ill, mechanically ventilated patients. Overall incidence as well as double triggering and flow starvation PVA specifically, portend worse outcome.

scholarly journals Impact of dexamethasone on the incidence of ventilator-associated pneumonia and blood stream infections in COVID-19 patients requiring invasive mechanical ventilation: a multicenter retrospective study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ines Gragueb-Chatti ◽  
Alexandre Lopez ◽  
Dany Hamidi ◽  
Christophe Guervilly ◽  
Anderson Loundou ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Retrospective Study ◽  
Length Of Stay ◽  
Critically Ill ◽  
Invasive Mechanical Ventilation ◽  
Blood Stream ◽  
Hospital Length Of Stay ◽  
Ventilator Associated Pneumonia ◽  
Blood Stream Infections ◽  
Second Wave

Abstract Background Dexamethasone decreases mortality in patients with severe coronavirus disease 2019 (COVID-19) and has become the standard of care during the second wave of pandemic. Dexamethasone is an immunosuppressive treatment potentially increasing the risk of secondary hospital acquired infections in critically ill patients. We conducted an observational retrospective study in three French intensive care units (ICUs) comparing the first and second waves of pandemic to investigate the role of dexamethasone in the occurrence of ventilator-associated pneumonia (VAP) and blood stream infections (BSI). Patients admitted from March to November 2020 with a documented COVID-19 and requiring mechanical ventilation (MV) for ≥ 48 h were included. The main study outcomes were the incidence of VAP and BSI according to the use of dexamethasone. Secondary outcomes were the ventilator-free days (VFD) at day-28 and day-60, ICU and hospital length of stay and mortality. Results Among the 151 patients included, 84 received dexamethasone, all but one during the second wave. VAP occurred in 63% of patients treated with dexamethasone (DEXA+) and 57% in those not receiving dexamethasone (DEXA−) (p = 0.43). The cumulative incidence of VAP, considering death, duration of MV and late immunosuppression as competing factors was not different between groups (p = 0.59). A multivariate analysis did not identify dexamethasone as an independent risk factor for VAP occurrence. The occurrence of BSI was not different between groups (29 vs. 30%; p = 0.86). DEXA+ patients had more VFD at day-28 (9 (0–21) vs. 0 (0–11) days; p = 0.009) and a reduced ICU length of stay (20 (11–44) vs. 32 (17–46) days; p = 0.01). Mortality did not differ between groups. Conclusions In this cohort of COVID-19 patients requiring invasive MV, dexamethasone was not associated with an increased incidence of VAP or BSI. Dexamethasone might not explain the high rates of VAP and BSI observed in critically ill COVID-19 patients.

scholarly journals High-dose vitamin C infusion for the treatment of critically ill COVID-19

2020 ◽  
Author(s):  
Jing Zhang ◽  
Xin Rao ◽  
Yiming Li ◽  
Yuan Zhu ◽  
Fang Liu ◽  
...  
Keyword(s):  
Placebo Group ◽  
Vitamin C ◽  
Critically Ill ◽  
Day Treatment ◽  
Invasive Mechanical Ventilation ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
C 50 ◽  
Intravenous Vitamin ◽  
High Dose Vitamin

Abstract BackgroundNo specific medication has been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19.MethodsThis randomized, controlled clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 hours for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way. The primary outcome was invasive mechanical ventilation-free days in 28 days(IMVFD28). Secondary outcomes were 28-day mortality, organ failure, and inflammation progression.ResultsFifty-four critical COVID-19 patients were ultimately recruited. There was no difference in IMVFD28 between two groups. During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P = 0.01). Patients with SOFA scores ≥ 3 in the HDIVC group exhibited a significant reduction in 28-day mortality (P = 0.05) in univariate survival analysis. IL-6 in the VC group was lower than that in the placebo group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P = 0.04) on day 7.ConclusionThe addition of HDIVC may provide a protective clinical effect without any adverse events in critically ill patients with COVID-19.Clinicaltrial.gov identifer: NCT04264533

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