Dataset Information

Efficacy of therapeutic plasma exchange in the treatment of penn class 3 and 4 cytokine release syndrome complicating COVID-19.

ABSTRACT:

Objectives

Cytokine release syndrome (CRS) is a potentially severe complication of COVID-19 most commonly resulting in respiratory failure. This ten-patient study was designed to determine the efficacy of therapeutic plasma exchange (TPE) in improving oxygenation and in reducing the cytokine load in a critically ill subset of patients.

Methods

Five single volume plasma exchanges over eight days within a 14-day study period. In mechanically ventilated patients, oxygenation was measured via the PaO2/FiO2 (P/F) ratio and the oxygenation index (OI) daily for 14 days. Supplemental oxygen requirements were tracked daily for non-ventilated patients.

Results

Non-ventilated patients were liberated from supplemental oxygen after TPE. The response was rapid with an 87% average reduction in oxygenation requirements following and average time to return to room air of 5.25 days. All mechanically ventilated patients demonstrated improvement in oxygenation with a 78% average improvement in the P/F ratio and a 43% improvement in OI. C-reactive protein (CRP) and serum levels of IL-6, IL-8, IL-10, TNF?, IFN? and GM-CSF, were measured daily with immediate post TPE levels drawn on days 1, 2, 4, 6 and 8. All patients demonstrated significant reductions in CRP, IL-6, IL-10 and TNF?.

Conclusions

In the majority of patients with Penn class 3 and 4 CRS complicating COVID-19, TPE demonstrated a prompt improvement in oxygenation and reduction in cytokine load without compromising patient safety. As this pilot study was envisioned to be hypothesis generating, expanded trials using TPE alone and in conjunction with novel pharmacologic agents are warranted.

Registration

ClinicalTrials.gov NCT04374149.

SUBMITTER: Gluck WL

PROVIDER: S-EPMC7648522 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Efficacy of therapeutic plasma exchange in the treatment of penn class 3 and 4 cytokine release syndrome complicating COVID-19.

Gluck W Larry WL Callahan Sean P SP Brevetta Robert A RA Stenbit Antine E AE Smith Wesley M WM Martin Julie C JC Blenda Anna V AV Arce Sergio S Edenfield W Jeffery WJ

Respiratory medicine 20201107

<h4>Objectives</h4>Cytokine release syndrome (CRS) is a potentially severe complication of COVID-19 most commonly resulting in respiratory failure. This ten-patient study was designed to determine the efficacy of therapeutic plasma exchange (TPE) in improving oxygenation and in reducing the cytokine load in a critically ill subset of patients.<h4>Methods</h4>Five single volume plasma exchanges over eight days within a 14-day study period. In mechanically ventilated patients, oxygenation was meas ...[more]

PMID: 33190086

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Project description:BackgroundCytokine release syndrome (CRS) plays a pivotal role in the pathophysiology and progression of Coronavirus disease-2019 (COVID-19). Therapeutic plasma exchange (TPE) by removing the pathogenic cytokines is hypothesized to dampen CRS.ObjectiveTo evaluate the outcomes of the patients with COVID-19 having CRS being treated with TPE compared to controls on the standard of care.MethodologyRetrospective propensity score-matched analysis in a single centre from 1st April to 31st July 2020. We retrospectively analyzed data of 280 hospitalized patients developing CRS initially. PSM was used to minimize bias from non-randomized treatment assignment. Using PSM 1:1, 90 patients were selected and assigned to 2 equal groups. Forced matching was done for disease severity, routine standard care and advanced supportive care. Many other Co-variates were matched. Primary outcome was 28 days overall survival. Secondary outcomes were duration of hospitalization, CRS resolution time and timing of viral clearance on Polymerase chain reaction testing.ResultsAfter PS-matching, the selected cohort had a median age of 60 years (range 32-73 in TPE, 37-75 in controls), p = 0.325 and all were males. Median symptoms duration was 7 days (range 3-22 days' TPE and 3-20 days controls), p = 0.266. Disease severity in both groups was 6 (6.6%) moderate, 40 (44.4%) severe and 44 (49%) critical. Overall, 28-day survival was significantly superior in the TPE group (91.1%), 95% CI 78.33-97.76; as compared to PS-matched controls (61.5%), 95% CI 51.29-78.76 (log rank 0.002), p<0.001. Median duration of hospitalization was significantly reduced in the TPE treated group (10 days vs 15 days) (p< 0.01). CRS resolution time was also significantly reduced in the TPE group (6 days vs. 12 days) (p< 0.001). In 71 patients who underwent TPE, the mortality was 0 (n = 43) if TPE was done within the first 12 days of illness while it was 17.9% (deaths 5, n = 28 who received it after 12th day (p = 0.0045).ConclusionAn earlier use of TPE was associated with improved overall survival, early CRS resolution and time to discharge compared to SOC for COVID-19 triggered CRS in this selected cohort of PS-matched male patients from one major hospital in Pakistan.

Project description:BackgroundFulminant (life-threatening) COVID-19 can be associated with acute respiratory failure (ARF), multi-system organ failure and cytokine release syndrome (CRS). We present a rare case of fulminant COVID-19 associated with reverse-takotsubo-cardiomyopathy (RTCC) that improved with therapeutic plasma exchange (TPE).Case presentationA 40 year old previous healthy male presented in the emergency room with 4 days of dry cough, chest pain, myalgias and fatigue. He progressed to ARF requiring high-flow-nasal-cannula (flow: 60 L/minute, fraction of inspired oxygen: 40%). Real-Time-Polymerase-Chain-Reaction (RT-PCR) assay confirmed COVID-19 and chest X-ray showed interstitial infiltrates. Biochemistry suggested CRS: increased C-reactive protein, lactate dehydrogenase, ferritin and interleukin-6. Renal function was normal but lactate levels were elevated. Electrocardiogram demonstrated non-specific changes and troponin-I levels were slightly elevated. Echocardiography revealed left ventricular (LV) basal and midventricular akinesia with apex sparing (LV ejection fraction: 30%) and depressed cardiac output (2.8 L/min) consistent with a rare variant of stress-related cardiomyopathy: RTCC. His ratio of partial arterial pressure of oxygen to fractional inspired concentration of oxygen was < 120. He was admitted to the intensive care unit (ICU) for mechanical ventilation and vasopressors, plus antivirals (lopinavir/ritonavir), and prophylactic anticoagulation. Infusion of milrinone failed to improve his cardiogenic shock (day-1). Thus, rescue TPE was performed using the Spectra Optia™ Apheresis System equipped with the Depuro D2000 Adsorption Cartridge (Terumo BCT Inc., USA) without protective antibodies. Over 5 days he received daily TPE (each lasting 4 hours). His lactate levels, oxygenation, and LV function normalized and he was weaned off vasopressors. His inflammation markers improved, and he was extubated on day-7. RT-PCR was negative on day-17. He was discharged to home isolation in good condition.ConclusionStress-cardiomyopathy may complicate the course of fulminant COVID-19 with associated CRS. If inotropic therapy fails, TPE without protective antibodies may help rescue the critically ill patient.

Project description:BackgroundHELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome occurs in about 0.5%-0.9% of all pregnancies, but its prevalence is higher in patients with severe preeclampsia, accounting for a substantial maternal and perinatal morbidity and mortality. According to the latest American Society for Apheresis guidelines, Therapeutic plasma exchange (TPE) performed for postpartum cases and antepartum HELLP syndrome cases fall in Categories III and IV, respectively.Materials and methodsRetrospective analysis was done at our tertiary care center from January 2014 to June 2019 for patients diagnosed with HELLP syndrome. Clinical data for age, gestational age at the time of diagnosis, type of delivery, outcome of pregnancy, history of preeclampsia /eclampsia, hemoglobin levels, AST, ALT, LDH, platelet counts, prothrombin time, activated partial thromboplastin time, international normalised ratio, complete blood count, was obtained from patients' electronic medical records. The TPE was initiated within 24 hrs of diagnosis. All TPE was done on Spectra Optia apheresis system (Terumo BCT, Inc, USA). Statistical testing was conducted with the statistical package for the social science system version SPSS 20.0 and R-3.2.0. Continuous variables were expressed as mean±SD and were compared between Pre and Post TPE records of patients by using the paired T test.ResultsNine patients fulfilled the criteria of HELLP syndrome. Seven (77.8%) were diagnosed in the postpartum period and 2 (22.2%) during the second trimester. Out of the total nine patients, two patients (22.2%) recovered completely and were discharged on day 15 ± 7 days, whereas 4 (44.4%) patients were discharged on day 21 ± 7 days with the advice of hemodialysis. Two (22.2%) patients had an intrauterine death and were discharged 3-4 days after the demise. In all these patients (except one), the TPE was initiated within 24 h of the diagnosis. A significant increase in platelet count and decrease in the lactate dehydrogenase levels (P < 0.05) was observed post TPE.ConclusionOur data showed that TPE improved the treatment outcome in patients with HELLP syndrome despite being a Category III and IV indication among postpartum and antenatal females, respectively. However, a timely diagnosis and management are of paramount importance for a favorable outcome. TPE needs to be performed within 24 h of the diagnosis postdelivery when the patient is not responsive to the usual therapies, especially in class I HELLP syndrome.

Dataset Information

Efficacy of therapeutic plasma exchange in the treatment of penn class 3 and 4 cytokine release syndrome complicating COVID-19.

Objectives

Methods

Results

Conclusions

Registration

Publications

Efficacy of therapeutic plasma exchange in the treatment of penn class 3 and 4 cytokine release syndrome complicating COVID-19.

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