Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial.

BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.

Pressure-based beat-to-beat right ventricular ejection fraction and Tau from continuous measured ventricular pressures in COVID-19 ARDS patients.

We evaluated pressure-based right ventricular ejection fraction (RVEF) and diastolic isovolumetric relaxation time constant (Tau) from continuously (up to 30 days) invasive measured right ventricular pressures in mechanically ventilated patients with severe COVID-19 acute respiratory distress syndrome (ARDS). We retrospectively calculated beat-to-beat ejection fraction from right ventricular pressures and dp/dt maximum and minimum in 39 patients treated between October 1st, 2020 and June 30th, 2021. After performing a stepwise logistic regression with survival as a dependent variable, we divided the patients into survivors and nonsurvivors based on their 60-day mortality. Independent outcome variables were the values of RVEF and Tau over time after insertion of the right ventricular probe along with right ventricular systolic and diastolic pressures (RVSP) and the estimated pulmonary artery diastolic pressure (ePAD). RVEF increased significantly over time in the survivors (estimate: 0.354; 95% confidence interval, CI: 0.18-0.53; p < 0.001) but remained unchanged in the nonsurvivors. Tau increased significantly in the nonsurvivors (estimate: 0.001; 95% CI: 0.0004-0.0018; p < 0.002) but not in the survivors. On the last measurement day, RVSP and ePAD were significantly lower while RVEF was significantly higher in the survivors compared to the nonsurvivors. In COVID-19 ARDS patient's, calculation of beat-to-beat RVEF and Tau from continuously invasive measured right ventricular pressures seems to unravel contrary trends in RVEF with an increase in the surviving and a decrease in the nonsurviving patients. Tau remained unchanged in the surviving but increased in the nonsurviving patients over time.

[Personalized intensive care medicine : Implementation of therapeutic drug monitoring to assess antibiotic levels in intensive care patients]. / Personalisierte Intensivmedizin : Implementierung eines therapeutischen Drugmonitorings zur Bestimmung der Antibiotikaspiegel bei Intensivpatienten.

BACKGROUND: The intensive care unit at Asklepios Klinik Langen started a therapeutic drug monitoring (TDM) project in cooperation with the Aukamm pharmacy in Wiesbaden to measure antibiotic concentrations in the serum of intensive care patients for providing plasma level guided anti-infective therapy. METHODS: The serum levels of the ß­lactam antibiotics meropenem, piperacillin, ceftriaxone and ceftazidime as well as the glycylcycline antibiotic tigecycline measured between January 1 and December 31, 2020, were evaluated retrospectively. Quantification by high performance liquid chromatography was carried out by the Aukamm pharmacy. RESULTS: During the observation period 288 serum level measurements were carried out in 131 patients with normal as well as impaired kidney or liver function, an increased volume of distribution as well as in patients with extracorporeal organ replacement therapies. The results of the most frequently measured antibiotic piperacillin/tazobactam showed a range of 1.95-308.50 µg/ml (median 76.54 µg/ml). The median serum level for meropenem was 26.46 µg/ml (0.75-157.36 µg/ml), for ceftriaxone 33.53 µg/ml (8.38-236.26 µg/ml) and for ceftazidime 158.56 µg/ml (24.09-204.61 µg/ml). The median trough level for tigecycline was 0.42 µg/ml (0.25-3.7 µg/ml) and therefore lower compared to administration via continuous infusion (median 0.88 µg/ml, 0.26-3.81 µg/ml). CONCLUSIONS: Therapeutic drug monitoring was successfully implemented in the intensive care unit of the Asklepios Klinik Langen. The serum level measurements showed considerable clinically relevant fluctuations in the antibiotic concentrations. Even an only rough approximation of effective antibiotic serum levels is not possible without TDM.

Continuous long-term wireless measurement of right ventricular pressures and estimated diastolic pulmonary artery pressure in patients with severe COVID-19 acute respiratory distress syndrome.

AIMS: We continuously monitored right ventricular pressures and the estimated diastolic pulmonary artery pressure (ePAD) for up to 30 days in mechanically ventilated patients with severe COVID-19 acute respiratory distress syndrome in order to detect and treat right ventricular and pulmonary artery hypertension. METHODS AND RESULTS: We retrospectively evaluated right ventricular pressures and the ePAD measured in 30 invasively ventilated COVID-19 acute respiratory distress syndrome patients between 1 October 2020 and 31 March 2021. We divided the patients into two groups, survivors and non-survivors based on their 60 day mortality. Primary outcome variables were the values of right ventricular pressures and the ePAD over time after insertion of the right ventricular probe. Right ventricular systolic pressure [RVSP, (IQR; 25th to 75th percentile)] was significantly lower on the first and the last measurement day in the survivors compared with the non-survivors [Day 1: 38 (27-45) vs. 46 (44-49), P = 0.036; last day: 36 (27-44) vs. 51 (40-57) mmHg, P = 0.006]. 16/22 survivors and 7/8 non-survivors received sildenafil orally, one survivor received additionally inhaled nitric oxide and one survivor and one non-survivor each inhaled iloprost. On the last measurement day, both right ventricular pressure amplitude [31 (26-37) vs. 38 (35-47) mmHg, P = 0.027] and ePAD [22 (16-26) vs. 31 (23-34) mmHg, P = 0.043] were significantly lower in the survivors compared with the non-survivors. Four patients in the survivor group developed excessive high RVSP in the course of their disease (peak: 57/61/78/105 mmHg). After sildenafil 20 mg every 8 h, additional inhaled nitric oxide (20 ppm) in one and additional inhaled iloprost 20 µg every 4 h in another patient RVSP consecutively decreased substantially in all four patients until the end of the measurement period (47/23/42/47 mmHg). CONCLUSIONS: The RVSP and right ventricular pressure amplitude both were significantly lower in the survivors compared with those in the non-survivors with a significant decrease in RVSP over time in the survivors suggesting successful lowering by pulmonary vasodilators. The ePAD as an indicator of left heart failure was significantly higher in non-survivors compared to the surviving patients.

Correction to: ECMO-treatment in patients with acute lung failure, cardiogenic, and septic shock: mortality and ECMO-learning curve over a 6-year period.

[This corrects the article DOI: 10.1186/s40560-018-0352-2.].

ECMO-treatment in patients with acute lung failure, cardiogenic, and septic shock: mortality and ECMO-learning curve over a 6-year period.

BACKGROUND: Based on promising results over the past 10 years, the method of extracorporeal membrane oxygenation (ECMO) has developed from being used as a 'rescue therapy' to become an accepted treatment option for patients with acute lung failure (ARDS). Subsequently, the indication was extended also to patients suffering from cardiogenic and septic shock. Our aim was to evaluate hospital mortality and associated prognostic variables in patients with lung failure, cardiogenic, and septic shock undergoing ECMO. Furthermore, a cumulative sum (CUSUM) analysis was used to assess the learning curve of ECMO-treatment in our department. METHODS: We retrospectively analysed the data of 131 patients undergoing ECMO treatment in the intensive care unit of the Asklepios Hospital of Langen over the time period from April 2011 to July 2016. We categorised the patients into three groups: lung failure (n = 54); cardiogenic shock (n = 58); and septic shock (n = 19). The primary outcome variable was hospital mortality along with identification of prognostic variables on mortality before initiating ECMO using logistic regression. Second outcome variable was the learning curve of our department in patients with ECMO. RESULTS: 6-year hospital mortality was 54% in patients with lung failure, 59% in patients with cardiogenic shock, and 58% in patients with septic shock.The CUSUM analysis revealed a typical learning curve with a point of inflection in the year 2014. Patients treated before 2014 had a worse outcome (p = 0.04 whole cohort; p = 0.03 for lung failure). Furthermore, less than 20 treatments per year respectively treatment before 2014 were associated negatively with hospital mortality of lung failure patients showing an odds ratio of 4.04, as well as in the entire cohort with an odds ratio of 3.19. CONCLUSION: For the first time, a steep ECMO-learning curve using the CUSUM tool has been described. Obviously, the experience with ECMO has to be taken into account when defining the role of ECMO in ARDS, cardiogenic, and septic shock.

Short-term cardiovascular effects of plasmapheresis in norepinephrine-refractory septic shock.

OBJECTIVE: To examine the short-term cardiovascular effects of plasmapheresis in seven patients (six surgical, one medical) with norepinephrine-refractory septic shock. DESIGN AND SETTING: Retrospective observational study in a secondary community hospital. INTERVENTIONS: Plasmapheresis was performed as follows: blood flow, 120 ml/min; exchange volume, 10 fresh frozen plasma (ca. 2200 ml) at rate of 13 ml/min; anticoagulation, unfractionated heparin 200-300/IU/h. Five patients received one separation and two patients three separations. All patients received norepinephrine intravenously (0.6+/-0.7 micro g/kg per minute) to achieve a mean arterial pressure of 77+/-12 mmHg. All patients received ventilatory support; two had acute oligoanuric renal failure treated by continuous hemodiafiltration. MEASUREMENTS AND RESULTS: We recorded heart rate, mean arterial pressure, central venous pressure, catecholamine dose, gas exchange, acid-base status, diuresis, C-reactive protein, white blood cell count, and Simplified Acute Physiological Score II. Except for transitory decreases in central venous pressure no changes were found in any variable. Six of seven patients died 5+/-3 days after the last plasmapheresis. CONCLUSIONS: In patients with norepinephrine-refractory septic shock no directional changes in measured variables were found in the first 24 h after a plasmapheresis. Thus, regarding the cost (ca. 1000 euros per separation) and possible risks the procedure needs rigorous evaluation even as "rescue therapy" in patients with septic shock.

Diálisis sostenida de baja eficiencia en una unidad de cuidados intensivos interdisciplinarios: un análisis costo-beneficio a 5 años / Sustained low efficiency dialysis as standard renal replacement therapy in an interdisciplinary intensive care unit - A five year cost-benefit analysis

Conocimientos: La diálisis sostenida de baja eficiencia (sustained loui efficiency dialysis [SLED]) como terapia primaria de reemplazo renal en la lesión renal aguda no está muy extendida, a pesar de sustanciales ventajas económicas. Nosotros evaluamos los costos y los resultados en un estudio retrospectivo de 5 años en nuestra unidad de cuidados intensivos (UCI). Métodos: Desde 2006 hasta 2010 seleccionamos todos los pacientes con los códigos ICD-10 N17 y N18 que fueron tratados con SLED en nuestra UCI. Fueron excluidos los pacientes con una estancia de menos de 2 días, una indicación extrarrenal para diálisis o la diálisis crónica. Las variables fueron: el número de SLED, la duración en la UCI y la estancia hospitalaria, la mortalidad hospitalaria y en la UCI, SAPSII, TISS28, la urea y la creatinina séricas, la proteína C reactiva, la ventilación mecánica y los diagnósticos. El resultado a largo plazo se evaluó mediante el envío de un cuestionario a todos los pacientes dados de alta. Resultados: Entre 2006 y 2010 se llevaron a cabo 3.247 tratamientos de SLED en 421 pacientes (media de SAPSII: 41 puntos sin GCS). La mortalidad en la UCI y el hospital de los pacientes tratados solo con SLED (n = 392) fue del 34 y del 45%, respectivamente. El 71% de todos los pacientes que sobrevivieron tenían buena calidad de vida y el 12% de todos los pacientes dados de alta aún necesitaban diálisis. Los costos totales de SLED fueron de 526.819 €, y el producto total, de 734.996€. Si se considera 3.247 «días de hemodiafiltración venovenosa continua [HDFVVC]¼ para las comparaciones de costos, se calcularon los costos en 729.991 € con el producto de 690.864€ para HDFWC. Conclusiones: En los pacientes críticamente enfermos con lesión renal aguda la SLED es una eficaz terapia de reemplazo renal con resultados a corto y largo plazo que son comparables a los datos de los resultados de HDFVVC. En base a nuestro análisis de costo-beneficios, SLED parece ser la terapia preferible de reemplazo renal.

Background: Sustained low efficiency dialysis (SLED) as primary renal replacement therapy (RRT) in acute kidney injury (AKI) is not widely used, despite substantial economic advantages. We evaluated costs and outcome in a 5 year retrospective study on our ICU. Methods: From 2006 to 2010 we selected all patients with the ICD-10 codes N17 and N18 who were treated with SLED on our ICU. Patients with a stay <2 days, an extra-renal indication for dialysis or chronic dialysis were excluded. Variables: number of SLEDs, duration of ICU and hospital stay, ICU and hospital mortality, SAPS II, TISS 28, blood urea and creatinine, C-reactive protein, mechanical ventilation, diagnoses. Long-term outcome was evaluated by sending all discharged patients a questionnaire. Results: Between 2006 and 2010, 3247 SLED-treatments in 421 patients (mean SAPS II: 41 points without GCS) were performed. ICU and hospital mortality in the patients treated only with SLED (n = 392) was 34% and 45%, respectively. 71% of all surviving patients had good quality of life and 12% of all discharged patients still needed dialysis. Total costs for SLED were 526.819 € and total proceeds were 734.996 €. Assuming also 3247 «CWHDF-days¼ for cost comparisons we calculated costs of 729.991 € with proceeds of 690.864 € for CVVHDF. Conclusions: In critically ill patients with AKI SLED is an effective RRT, with short- and long-term outcome being comparable to outcome data with CVVHDF. Based on our cost-proceeds analysis SLED seems to be the preferable renal replacement therapy.