Die postoperative Anämie ist ein unabhängiger Risikofaktor für das postoperative Delir und eine verlängerte Hospitalisierung

Die postoperative Anämie ist ein potenzieller Risikofaktor für das postoperative Delir und eine verlängerte Hospitalisierung: Sekundäranalyse einer prospektiven Kohortenstudie. Einleitung: Die postoperative Anämie ist eine häufige Komplikation im Rahmen eines chirurgischen Eingriffes. Im Gegensatz zur präoperativen Anämie gibt es hierzu weitaus weniger Daten zur Inzidenz und klinischen Relevanz. Durch eine potenzielle cerebrale Oxygenierungsstörung könnte die postoperative Anämie zum postoperativen Delir führen. Das Ziel dieser Sekundäranalyse ist, die Assoziation von postoperativer Anämie nach geschlechtsspezifischer Definition der World Health Organization und einen möglichen Zusammenhang zur Krankenhausverweildauer zu untersuchen. Methodik: Es wurde eine Subanalyse der 800 Patienten der multizentrischen CESARO-Studie durchgeführt. Hierbei handelt es sich um eine prospektive Observationsstudie von volljährigen Patienten, an denen ein elektiver nicht-kardialer chirurgischer Eingriff vorgenommen wurde. Die sieben teilnehmenden Zentren bestanden aus Universitätskliniken der Maximalversorgung, einem Kreiskrankenhaus sowie einer auf minimalinvasive Chirurgie spezialisierten Klinik. Es wurde die Definition der World Health Organization (WHO) für Anämie verwendet, laut der eine Hämoglobinkonzentration von weniger als 12g/dl beim weiblichen Geschlecht und beim männlichen Geschlecht von weniger als 13g/dl eine Anämie beschreibt. Der Fokus lag dabei auf der akuten postoperativen Anämie: Patienten mit vorbestehender präoperativer Anämie wurden ausgeschlossen. Das postoperative Delir wurde mit Hilfe der validierten Nursing Delirium Screening Scale mindestens bis 24 Stunden nach operativem Eingriff und maximal bis zum dritten postoperativen Tag gescreent. Ergebnisse: Bei 183 der 800 Patienten lag eine vollständige Dokumentation der prä- und postoperativen Hämoglobinkonzentration vor. Eine postoperative Anämie trat bei 90 Patienten auf. Dies entspricht einer Anämie-Inzidenz von 49,2%. Bei 10 der 93 (10.9%) Patienten, die keine postoperative Anämie erlitten, trat ein postoperatives Delir auf. In der Gruppe der Patienten mit postoperativer Anämie trat das postoperative Delir bei 28 (38,4%) Patienten auf (odds ratio 3,949 (95% Konfidenzintervall, (1,358-11,480), bereinigt für NYHA-Stadium, Schwere der Operation, Schnitt/Naht-Zeit, Dauer der Anästhesie, Transfusion von Erythrozytenkonzentraten und postoperativem Sedierungsstatus gemäß Richmond Agitation Scale. Darüber hinaus war die Krankenhausverweildauer bei Patienten mit postoperativer Anämie signifikant verlängert (7,75 vs. 12,42 Tagen, odds ratio = 1,186, 95% Konfidenzintervall, 1,083-1,299, nach Bereinigung). Schlussfolgerung: Die postoperative Anämie ist nicht nur eine häufige Komplikation mit fast 50% Inzidenz, sondern auch ein unabhängiger Prädiktor für postoperatives Delir und verlängerte Krankenhausverweildauer.Postoperative anaemia might be a risk factor for postoperative delirium and prolonged hospital stay: A secondary analysis of a prospective cohort study. Background: Postoperative anaemia is a frequent surgical complication and in contrast to preoperative anaemia has not been validated in relation to mortality, morbidity and its associated health economic effect. Postoperative anaemia can predispose postoperative delirium through impairment of cerebral oxygenation. The aim of this secondary analysis is to investigate the association of postoperative anaemia in accordance with the sex specific World Health Organization definition of anaemia to postoperative delirium and its impact on the duration of hospital stay. Methods: A secondary analysis of the prospective multicentric observational CESARO-study was conducted. 800 adult patients undergoing elective surgery were enrolled from various operative disciplines across seven hospitals ranging from university hospitals, district general hospitals to specialist clinics of minimally invasive surgery in Germany. Patients were classified as anaemic according to the World Health Organization parameters, setting the haemoglobin level cut off below 12g/dl for females and below 13g/dl for males. Focus of the investigation were patients with acute anaemia. Patients with present preoperative anaemia or missing haemoglobin measurement were excluded from the sample set. Delirium screening was established postoperatively for at least 24 hours and up to three days, applying the validated Nursing Delirium Screening Scale. Results: The initial sample set contained 800 patients of which 183 were suitable for analysis in the study. Ninety out of 183 (49.2%) suffered from postoperative anaemia. Ten out of 93 (10.9%) patients without postoperative anaemia developed a postoperative delirium. In the group with postoperative anaemia, 28 (38.4%) out of 90 patients suffered from postoperative delirium (odds ratio 3.949, 95% confidence interval, (1.358-11.480)) after adjustment for NYHA-stadium, severity of surgery, cutting/suture time, duration of anaesthesia, transfusion of packed red cells and sedation status with Richmond Agitation Scale after surgery. Additionally, patients who suffered from postoperative anaemia showed a significantly longer duration of hospitalisation (7.75 vs. 12.42 days, odds ratio = 1.186, 95% confidence interval, 1.083-1.299, after adjustments). Conclusion: The study results reveal that postoperative anaemia is not only a frequent postsurgical complication with an incidence probability of almost 50%, but could also be associated with a postoperative delirium and a prolonged hospitalisation[1]

Postoperative Anaemia Might Be a Risk Factor for Postoperative Delirium and Prolonged Hospital Stay: A Secondary Analysis of a Prospective Cohort Study

Background: Postoperative anaemia is a frequent surgical complication and in contrast to preoperative anaemia has not been validated in relation to mortality, morbidity and its associated health economic effect. Postoperative anaemia can predispose postoperative delirium through impairment of cerebral oxygenation. The aim of this secondary analysis is to investigate the association of postoperative anaemia in accordance with the sex specific World Health Organization definition of anaemia to postoperative delirium and its impact on the duration of hospital stay. Methods: A secondary analysis of the prospective multicentric observational CESARO-study was conducted. 800 adult patients undergoing elective surgery were enrolled from various operative disciplines across seven hospitals ranging from university hospitals, district general hospitals to specialist clinics of minimally invasive surgery in Germany. Patients were classified as anaemic according to the World Health Organization parameters, setting the haemoglobin level cut off below 12g/dl for females and below 13g/dl for males. Focus of the investigation were patients with acute anaemia. Patients with present preoperative anaemia or missing haemoglobin measurement were excluded from the sample set. Delirium screening was established postoperatively for at least 24 hours and up to three days, applying the validated Nursing Delirium Screening Scale. Results: The initial sample set contained 800 patients of which 183 were suitable for analysis in the study. Ninety out of 183 (49.2%) suffered from postoperative anaemia. Ten out of 93 (10.9%) patients without postoperative anaemia developed a postoperative delirium. In the group with postoperative anaemia, 28 (38.4%) out of 90 patients suffered from postoperative delirium (odds ratio 3.949, 95% confidence interval, (1.358-11.480)) after adjustment for NYHA-stadium, severity of surgery, cutting/suture time, duration of anaesthesia, transfusion of packed red cells and sedation status with Richmond Agitation Scale after surgery. Additionally, patients who suffered from postoperative anaemia showed a significantly longer duration of hospitalisation (7.75 vs. 12.42 days, odds ratio = 1.186, 95% confidence interval, 1.083-1.299, after adjustments). Conclusion: The study results reveal that postoperative anaemia is not only a frequent postsurgical complication with an incidence probability of almost 50%, but could also be associated with a postoperative delirium and a prolonged hospitalisation

CytoResc – “CytoSorb” Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial

Objectives Approximately 8 - 10 % of COVID-19 patients present with a serious clinical course and need for hospitalization, 8% of hospitalized patients need ICU-treatment. Currently, no causal therapy is available and treatment is purely supportive. The main reason for death in critically ill patients is acute respiratory failure. However, in a number of patients a severe hyperinflammatory response with excessively elevated proinflammatory cytokines causes vasoplegic shock resistant to vasopressor therapy. A new polystyrene-based hemoadsorber (CytoSorb®, Cytosorbents Inc., New Jersey, USA) has been shown to adsorb effectively cytokines and other middle molecular weight toxins this way reducing their blood concentrations. This has been routinely used in clinical practice in the EU for other conditions where a cytokine storm occurs and an observational study has just been completed on COVID-19 patients. We hypothesized that the extracorporeal elimination of cytokines in critically ill COVID-19 patients with suspected hyperinflammation and shock may stabilize hemodynamics and improve outcome. The primary endpoint is time until resolution of vasoplegic shock, which is a well implemented, clinically relevant endpoint in critical care studies. Trial design Phase IIb, multicenter, prospective, open-label, randomized, 1:1 parallel group pilot study comparing the additional use of “CytoSorb” to standard of care without “CytoSorb”. Participants Patients are recruited from the Intensive Care Units (ICUs) of 7 participating centers in Germany (approximately 10 ICUs). All patients aged 18- 80 with positive polymerase chain reaction (PCR) test for SARS-CoV-2, a C-reactive protein (CRP) ≥ 100 mg/l, a Procalcitonin (PCT) 0.2 μg/min/kg to achieve a Mean Arterial Pressure ≥ 65mmHg). Patients are included irrespective of indication for renal replacement therapy. Suspected or proven bacterial cause for vasoplegic shock is a contraindication. Intervention and comparator Within 24 hours after meeting the inclusion criteria patients will be randomized to receive either standard of care or standard of care and additional “CytoSorb” therapy via a shaldon catheter for 3-7 days. Filter exchange is done every 24 hours. If patients receive antibiotics, an additional dose of antibiotics is administered after each change of “CytoSorb” filter in order to prevent underdosing due to “CytoSorb” treatment. Main outcomes Primary outcome is time to resolution of vasoplegic shock (defined as no need for vasopressors for at least 8 hours in order to sustain a MAP ≥ 65mmHg) in days. Secondary outcomes are 7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of “CytoSorb” and acute kidney injury. Randomization An electronic randomization will be performed using the study software secuTrial® administered by the Clinical Study Center (CSC) of the Charité – Universitätsmedizin Berlin, Germany. Randomization is done in blocks by 4 stratified by including center. Blinding (masking) The trial will be non-blinded for the clinicians and patients. The statistician will receive a blinded data set, so that all analyses will be conducted blinded. Numbers to be randomized (sample size) As this is a pilot study with the goal to examine the feasibility of the study design as well as the intervention effect, no formal sample size calculation was conducted. A total number of approximately 80-100 patients is planned (40-50 patients per group). Safety assessment is done after the inclusion of each 10 patients per randomization group. Trial Status Please see the study protocol version from April 24 2020. Recruitment of patients is still pending. Trial registration The study was registered on April 27 2020 in the German Registry of Clinical Trials (DRKS) under the number DRKS00021447. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol