Effect of Hemadsorption Therapy in Critically Ill Patients with COVID-19 (CYTOCOV-19): A Prospective Randomized Controlled Pilot Trial.

INTRODUCTION: Immunomodulatory therapies have shown beneficial effects in patients with severe COVID-19. Patients with hypercytokinemia might benefit from the removal of inflammatory mediators via hemadsorption. METHODS: Single-center prospective randomized trial at the University Medical Center Hamburg-Eppendorf (Germany). Patients with confirmed COVID-19, refractory shock (norepinephrine ≥0.2 µg/kg/min to maintain a mean arterial pressure ≥65 mm Hg), interleukin-6 (IL-6) ≥500 ng/L, and an indication for renal replacement therapy or extracorporeal membrane oxygenation were included. Patients received either hemadsorption therapy (HT) or standard medical therapy (SMT). For HT, a CytoSorb® adsorber was used for up to 5 days and was replaced every 18-24 h. The primary endpoint was sustained hemodynamic improvement (norepinephrine ≤0.05 µg/kg/min ≥24 h). RESULTS: Of 242 screened patients, 24 were randomized and assigned to either HT (N = 12) or SMT (N = 12). Both groups had similar severity as assessed by SAPS II (median 75 points HT group vs. 79 SMT group, p = 0.590) and SOFA (17 vs. 16, p = 0.551). Median IL-6 levels were 2,269 (IQR 948-3,679) and 3,747 (1,301-5,415) ng/L in the HT and SMT groups at baseline, respectively (p = 0.378). Shock resolution (primary endpoint) was reached in 33% (4/12) versus 17% (2/12) in the HT and SMT groups, respectively (p = 0.640). Twenty-eight-day mortality was 58% (7/12) in the HT compared to 67% (8/12) in the SMT group (p = 1.0). During the treatment period of 5 days, 6/12 (50%) of the SMT patients died, in contrast to 1/12 (8%) in the HT group. CONCLUSION: HT was associated with a non-significant trend toward clinical improvement within the intervention period. In selected patients, HT might be an option for stabilization before transfer and further therapeutic decisions. This finding warrants further investigation in larger trials.

Percutaneous dilatational tracheostomy with single use bronchoscopes versus reusable bronchoscopes - a prospective randomized trial (TraSUB).

BACKGROUND: Apart from conventional reusable bronchoscopes, single-use bronchoscopes (SUB) were recently introduced. Data suggest that SUB might prevent from the risk of cross contamination (i.e. multiresistant pathogens, SARS CoV-2) and save costs. We aimed to investigate visualization, ventilation, handling characteristics, changes in patients' gas exchange, and costs associated with both types of bronchoscopes during percutaneous dilatational tracheostomy (PDT). METHODS: In this prospective, randomized, noninferiority study, 46 patients undergoing PDT were randomized 1:1 to PDT with SUB (Ambu aScope) or reusable bronchoscopes (CONV, Olympus BF-P60). Visualization of tracheal structures rated on 4-point Likert scales was the primary end-point. Furthermore, quality of ventilation, device handling characteristics, changes in the patients' gas exchange, pH values, and costs were assessed. RESULTS: Noninferiority for visualization (the primary endpoint) was demonstrated for the SUB group. Mean visualization scores (lower values better) were 4.1 (95% confidence intervals: 3.9;4.3) for SUB vs. 4.1 (4.0;4.2) for CONV. Noninferiority of ventilation (estimated by minute volume and SpO2) during the procedure could be shown as well. Mean score was 2.6 (2.0;3.1) for SUB vs. 2.4 (2.1;2.7) for CONV (lower values better). No significant differences regarding handling (SUB: 1.2 (1.0;1.4), CONV: 1.3 (1.1;1.6)), blood gas analyses and respiratory variables were found. Cost analysis in our institution revealed 93 € per conventional bronchoscopy versus 232.50 € with SUB, not considering an estimate for possible infection due to cross-contamination with the reusable device. CONCLUSION: In our study, visualization and overall performance of the SUB during PDT were noninferior to reusable bronchoscopes. Therefore, PDT with SUB is feasible and should be considered if favored by individual institution's cost analysis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03952247 . Submitted for registration on 28/04/2019 and first posted on 16/05/2019.

Comparison of nasotracheal versus orotracheal intubation for sedation, assisted spontaneous breathing, mobilization, and outcome in critically ill patients: an exploratory retrospective analysis.

Nasotracheal intubation (NTI) may be used for long term ventilation in critically ill patients. Although tracheostomy is often favored, NTI may exhibit potential benefits. Compared to orotracheal intubation (OTI), patients receiving NTI may require less sedation and thus be more alert and with less episodes of depression of respiratory drive. We aimed to study the association of NTI versus OTI with sedation, assisted breathing, mobilization, and outcome in an exploratory analysis. Retrospective data on patients intubated in the intensive care unit (ICU) and ventilated for > 48 h were retrieved from electronic records for up to ten days after intubation. Outcome measures were a Richmond Agitation and Sedation Scale (RASS) of 0 or - 1, sedatives, vasopressors, assisted breathing, mobilization on the ICU mobility scale (ICU-MS), and outcome. From January 2018 to December 2020, 988 patients received OTI and 221 NTI. On day 1-3, a RASS of 0 or - 1 was attained in OTI for 4.0 ± 6.1 h/d versus 9.4 ± 8.4 h/d in NTI, p < 0.001. Propofol, sufentanil, and norepinephrine were required less frequently in NTI and doses were lower. The NTI group showed a higher proportion of spontaneous breathing from day 1 to 7 (day 1-6: p < 0.001, day 7: p = 0.002). ICU-MS scores were higher in the NTI group (d1-d9: p < 0.001, d10: p = 0.012). OTI was an independent predictor for mortality (odds ratio 1.602, 95% confidence interval 1.132-2.268, p = 0.008). No difference in the rate of tracheostomy was found. NTI was associated with less sedation, more spontaneous breathing, and a higher degree of mobilization during physiotherapy. OTI was identified as an independent predictor for mortality. Due to these findings a new prospective evaluation of NTI versus OTI should be conducted to study risks and benefits in current critical care medicine.

Surprising Hyperkalemia of 10.2 mmol/L in a Patient with Hyperglycemia: A Case Report.

Hyperkalemia is a life-threatening condition potentially leading to cardiac arrest. Here, we report a case of surprising severe hyperkalemia of 10.2 mmol/L in a diabetic patient with previously normal kidney function presenting without discernible clinical symptoms to our emergency department. The patient was admitted because of hyperglycemia of 32.8 mmol/L, which was detected during daily testing in her nursing home. The hyperkalemia was caused by prerenal failure due to hyperglycemic polyuria which led to volume depletion, and worsened by a combination of potassium-sparing drugs and potassium supplementation. The patient was treated conservatively. Eighteen hours later, the serum potassium concentration was 4.6 mmol/L. The patient could be released 6 days later. To our knowledge, this is the highest described hyperkalemia treated conservatively and survived without cardiopulmonary resuscitation.