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Registry on extracorporeal multiple organ support with the advanced organ support (ADVOS) system: 2-year interim analysis.

ABSTRACT:

Abstract

The objective of this registry is to collect data on real-life treatment conditions for patients for whom multiple organ dialysis with Advanced Organ Support (ADVOS) albumin hemodialysis is indicated.This registry was performed under routine conditions and without any study-specific intervention, diagnostic procedures, or assessments. Data on clinical laboratory tests, health status, liver function, vital signs, and examinations were collected (DRKS-ID: DRKS00017068). Mortality rates 28 and 90?days after the first ADVOS treatment, adverse events and ADVOS treatment parameters, including treatment abortions, were documented.This analysis was performed 2?years after the first patient was included on January 18, 2017. As of February 20, 2019, 4 clinical sites in Germany participated and enrolled 118 patients with a median age of 60 (IQR: 45, 69) of whom 70 were male (59.3%). Patients had a median SOFA Score of 14 (IQR: 11, 16) and a predicted mortality of 80%. The median number of failing organs was 3 (IQR: 2, 4).Four hundred twenty nine ADVOS treatments sessions were performed with a median duration of 17?hours (IQR: 6, 23). A 5.8% of the ADVOS sessions (25 of 429) were aborted due to device related errors, while 14.5% (62 of 429) were stopped for other reasons. Seventy nine adverse events were documented, 13 of them device related (all clotting, and all recovered without sequels).A significant reduction in serum creatinine (1.5 vs 1.2?mg/dl), blood urea nitrogen (24 vs 17?mg/dl) and bilirubin (6.9 vs 6.5?mg/dl) was observed following the first ADVOS treatment session. Blood pH, bicarbonate (HCO3-) and base excess returned to the physiological range, while partial pressure of carbon dioxide (pCO2) remained unchanged. At the time of the analysis, 28- and 90-day mortality were 60% and 65%, respectively, compared to an expected ICU-mortality rate of 80%. SOFA score was an independent predictor for outcome in a multivariable logistic regression analysis.The reported data show a high quality and completion of all participating centers. Data interpretation must be cautious due to the small number of patients, and the nature of the registry, without a control group. However, the data presented here show an improvement of expected mortality rates. Minor clotting events similar to other dialysis therapies occurred during the treatments.

SUBMITTER: Fuhrmann V

PROVIDER: S-EPMC7899840 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Registry on extracorporeal multiple organ support with the advanced organ support (ADVOS) system: 2-year interim analysis.

Fuhrmann Valentin V Perez Ruiz de Garibay Aritz A Perez Ruiz de Garibay Aritz A Faltlhauser Andreas A Tyczynski Bartosz B Jarczak Dominik D Lutz Jens J Weinmann-Menke Julia J Kribben Andreas A Kluge Stefan S

Medicine 20210201 7

<h4>Abstract</h4>The objective of this registry is to collect data on real-life treatment conditions for patients for whom multiple organ dialysis with Advanced Organ Support (ADVOS) albumin hemodialysis is indicated.This registry was performed under routine conditions and without any study-specific intervention, diagnostic procedures, or assessments. Data on clinical laboratory tests, health status, liver function, vital signs, and examinations were collected (DRKS-ID: DRKS00017068). Mortality ...[more]

PMID: 33607801

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Project description:BackgroundPrevalence of multiple organ failure (MOF) in critically ill patients is increasing and associated mortality remains high. Extracorporeal organ support is a cornerstone in the management of MOF. We report data of an advanced hemodialysis system based on albumin dialysis (ADVOS multi device) that can regulate acid-base balance in addition to the established properties of renal replacement therapy and albumin dialysis systems in critically ill patients with MOF.Methods34 critically ill patients with MOF received 102 ADVOS treatment sessions in the Department of Intensive Care Medicine of the University Medical Center Hamburg-Eppendorf. Markers of metabolic detoxification and acid-base regulation were collected and blood gas analyses were performed. A subgroup analyses were performed in patients with severe acidemia (pH < 7.2).ResultsMedian number of treatment sessions was 2 (range 1-9) per patient. Median duration of treatment was 17.5 (IQR 11-23) hours per session. Treatment with the ADVOS multi-albumin dialysis device caused a significant decrease in bilirubin levels, serum creatinine, BUN and ammonia levels. The relative elimination rate of bilirubin was concentration dependent. Furthermore, a significant improvement in blood pH, HCO3- and PaCO2, was achieved during ADVOS treatment including six patients that suffered from severe metabolic acidosis refractory to continuous renal replacement therapy. Delta pH, HCO3- and PaCO2 were significantly affected by the ADVOS blood flow rate and pH settings. This improvement in the clinical course during ADVOS treatments allowed a reduction in norepinephrine during ADVOS therapy. Treatments were well tolerated. Mortality rates were 50% and 62% for 28 and 90 days, respectively.ConclusionsIn this case series in patients with MOF, ADVOS was able to eliminate water-soluble and albumin-bound substances. Furthermore, the device corrected severe metabolic and respiratory acid-base disequilibrium. No major adverse events associated with the ADVOS treatments were observed.

Project description:Disturbed oxygenation is foremost the leading clinical presentation in COVID-19 patients. However, a small proportion also develop carbon dioxide removal problems. The Advanced Organ Support (ADVOS) therapy (ADVITOS GmbH, Munich, Germany) uses a less invasive approach by combining extracorporeal CO2 -removal and multiple organ support for the liver and the kidneys in a single hemodialysis device. The aim of our study is to evaluate the ADVOS system as treatment option in-COVID-19 patients with multi-organ failure and carbon dioxide removal problems. COVID-19 patients suffering from severe respiratory insufficiency, receiving at least two treatments with the ADVOS multi system (ADVITOS GmbH, Munich, Germany), were eligible for study inclusion. Briefly, these included patients with acute kidney injury (AKI) according to KDIGO guidelines, and moderate or severe ARDS according to the Berlin definition, who were on invasive mechanical ventilation for more than 72 hours. In total, nine COVID-19 patients (137 ADVOS treatment sessions with a median of 10 treatments per patient) with moderate to severe ARDS and carbon dioxide removal problems were analyzed. During the ADVOS treatments, a rapid correction of acid-base balance and a continuous CO2 removal could be observed. We observed a median continuous CO2 removal of 49.2 mL/min (IQR: 26.9-72.3 mL/min) with some treatments achieving up to 160 mL/min. The CO2 removal significantly correlated with blood flow (Pearson 0.421; P < .001), PaCO2 (0.341, P < .001) and HCO3- levels (0.568, P < .001) at the start of the treatment. The continuous treatment led to a significant reduction in PaCO2 from baseline to the last ADVOS treatment. In conclusion, it was feasible to remove CO2 using the ADVOS system in our cohort of COVID-19 patients with acute respiratory distress syndrome and multiorgan failure. This efficient removal of CO2 was achieved at blood flows up to 300 mL/min using a conventional hemodialysis catheter and without a membrane lung or a gas phase.

Project description:BackgroundThe lung, the kidney, and the liver are major regulators of acid-base balance. Acidosis due to the dysfunction of one or more organs can increase mortality, especially in critically ill patients. Supporting compensation by increasing ventilation or infusing bicarbonate is often ineffective. Therefore, direct removal of acid may represent a novel therapeutic approach. This can be achieved with the ADVanced Organ Support (ADVOS) system, an enhanced renal support therapy based on albumin dialysis. Here, we demonstrate proof of concept for this technology.MethodsAn ex vivo model of either hypercapnic (i.e., continuous CO2 supply) or lactic acidosis (i.e., lactic acid infusion) using porcine blood was subjected to hemodialysis with ADVOS. A variety of operational parameters including blood and dialysate flows, different dialysate pH settings, and acid and base concentrate compositions were tested. Comparisons with standard continuous veno-venous hemofiltration (CVVH) using high bicarbonate substitution fluid and continuous veno-venous hemodialysis (CVVHD) were also performed.ResultsSixty-one milliliters per minute (2.7 mmol/min) of CO2 was removed using a blood flow of 400 ml/min and a dialysate pH of 10 without altering blood pCO2 and HCO3- (36 mmHg and 20 mmol/l, respectively). Up to 142 ml/min (6.3 mmol/min) of CO2 was eliminated if elevated pCO2 (117 mmHg) and HCO3- (63 mmol/l) were allowed. During continuous lactic acid infusion, an acid load of up to 3 mmol/min was compensated. When acidosis was triggered, ADVOS multi normalized pH and bicarbonate levels within 1 h, while neither CVVH nor CVVHD could. The major determinants to correct blood pH were blood flow, dialysate composition, and initial acid-base status.ConclusionsIn conclusion, ADVOS was able to remove more than 50% of the amount of CO2 typically produced by an adult human. Blood pH was maintained stable within the physiological range through compensation of a metabolic acid load by albumin dialysate. These in vitro results will require confirmation in patients.

Project description:BackgroundMultiple major health organisations recommend the use of extracorporeal membrane oxygenation (ECMO) support for COVID-19-related acute hypoxaemic respiratory failure. However, initial reports of ECMO use in patients with COVID-19 described very high mortality and there have been no large, international cohort studies of ECMO for COVID-19 reported to date.MethodsWe used data from the Extracorporeal Life Support Organization (ELSO) Registry to characterise the epidemiology, hospital course, and outcomes of patients aged 16 years or older with confirmed COVID-19 who had ECMO support initiated between Jan 16 and May 1, 2020, at 213 hospitals in 36 countries. The primary outcome was in-hospital death in a time-to-event analysis assessed at 90 days after ECMO initiation. We applied a multivariable Cox model to examine whether patient and hospital factors were associated with in-hospital mortality.FindingsData for 1035 patients with COVID-19 who received ECMO support were included in this study. Of these, 67 (6%) remained hospitalised, 311 (30%) were discharged home or to an acute rehabilitation centre, 101 (10%) were discharged to a long-term acute care centre or unspecified location, 176 (17%) were discharged to another hospital, and 380 (37%) died. The estimated cumulative incidence of in-hospital mortality 90 days after the initiation of ECMO was 37·4% (95% CI 34·4-40·4). Mortality was 39% (380 of 968) in patients with a final disposition of death or hospital discharge. The use of ECMO for circulatory support was independently associated with higher in-hospital mortality (hazard ratio 1·89, 95% CI 1·20-2·97). In the subset of patients with COVID-19 receiving respiratory (venovenous) ECMO and characterised as having acute respiratory distress syndrome, the estimated cumulative incidence of in-hospital mortality 90 days after the initiation of ECMO was 38·0% (95% CI 34·6-41·5).InterpretationIn patients with COVID-19 who received ECMO, both estimated mortality 90 days after ECMO and mortality in those with a final disposition of death or discharge were less than 40%. These data from 213 hospitals worldwide provide a generalisable estimate of ECMO mortality in the setting of COVID-19.FundingNone.

Project description:ObjectivesRefractory postcardiotomy cardiogenic shock complicating cardiac surgery yields nearly 100% mortality when untreated. Use of venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock has increased worldwide recently. The aim of the current analysis was to outline the trends in use, changing patient profiles, and in-hospital outcomes including complications in patients undergoing venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock.DesignAnalysis of extracorporeal life support organization registry from January 2010 to December 2018.SettingMulticenter worldwide registry.PatientsSeven-thousand one-hundred eighty-five patients supported with venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock.InterventionsVenoarterial extracorporeal membrane oxygenation.Measurements and main resultsHospital death, weaning from extracorporeal membrane oxygenation, hospital complications. Mortality predictors were assessed by multivariable logistic regression. Propensity score matching was performed for comparison of peripheral and central cannulation for extracorporeal membrane oxygenation. A significant trend toward more extracorporeal membrane oxygenation use in recent years (coefficient, 0.009; p < 0.001) was found. Mean age was 56.3 ± 14.9 years and significantly increased over time (coefficient, 0.513; p < 0.001). Most commonly, venoarterial extracorporeal membrane oxygenation was instituted after coronary artery bypass surgery (26.8%) and valvular surgery (25.6%), followed by heart transplantation (20.7%). Overall, successful extracorporeal membrane oxygenation weaning was possible in 4,520 cases (56.4%), and survival to hospital discharge was achieved in 41.7% of cases. In-hospital mortality rates remained constant over time (coefficient, -8.775; p = 0.682), whereas complication rates were significantly reduced (coefficient, -0.009; p = 0.003). Higher mortality was observed after coronary artery bypass surgery (65.4%), combined coronary artery bypass surgery with valve (68.4%), and aortic (69.6%) procedures than other indications. Lower mortality rates were observed in heart transplantation recipients (46.0%). Age (p < 0.001), central cannulation (p < 0.001), and occurrence of complications while on extracorporeal membrane oxygenation were independently associated with poorer prognosis.ConclusionsThe analysis confirmed increased use of venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock. Mortality rates remained relatively constant over time despite a decrease in complications, in the setting of supporting older patients.

Dataset Information

Registry on extracorporeal multiple organ support with the advanced organ support (ADVOS) system: 2-year interim analysis.

Abstract

Publications

Registry on extracorporeal multiple organ support with the advanced organ support (ADVOS) system: 2-year interim analysis.

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