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PURPOSE: The influence of new SARS-CoV-2 variants on the post-COVID-19 condition (PCC) remains unanswered. Therefore, we examined the prevalence and predictors of PCC-related symptoms in patients infected with the SARS-CoV-2 variants delta or omicron. METHODS: We compared prevalences and risk factors of acute and PCC-related symptoms three months after primary infection (3MFU) between delta- and omicron-infected patients from the Cross-Sectoral Platform of the German National Pandemic Cohort Network. Health-related quality of life (HrQoL) was determined by the EQ-5D-5L index score and trend groups were calculated to describe changes of HrQoL between different time points. RESULTS: We considered 758 patients for our analysis (delta: n = 341; omicron: n = 417). Compared with omicron patients, delta patients had a similar prevalence of PCC at the 3MFU (p = 0.354), whereby fatigue occurred most frequently (n = 256, 34%). HrQoL was comparable between the groups with the lowest EQ-5D-5L index score (0.75, 95% CI 0.73-0.78) at disease onset. While most patients (69%, n = 348) never showed a declined HrQoL, it deteriorated substantially in 37 patients (7%) from the acute phase to the 3MFU of which 27 were infected with omicron. CONCLUSION: With quality-controlled data from a multicenter cohort, we showed that PCC is an equally common challenge for patients infected with the SARS-CoV-2 variants delta and omicron at least for the German population. Developing the EQ-5D-5L index score trend groups showed that over two thirds of patients did not experience any restrictions in their HrQoL due to or after the SARS-CoV-2 infection at the 3MFU. CLINICAL TRAIL REGISTRATION: The cohort is registered at ClinicalTrials.gov since February 24, 2021 (Identifier: NCT04768998).
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BACKGROUND: One of the leading causes of maternal death worldwide is severe obstetric haemorrhage after childbirth. Use of intraoperative cell salvage is strongly recommended by international guidelines on patient blood management. Recent data provide strong evidence that use of cell salvage in obstetrics is effective and safe in women with postpartum haemorrhage resulting in fewer transfusion-related adverse events and shorter hospital stay. We retrospectively analysed the use of cell salvage in bleeding women during delivery for a period of 10 yr in German hospitals. METHODS: Data from the German Federal Statistical Office were used that covers all in-hospital birth deliveries from 2011 to 2020. Prevalence of peripartum haemorrhage (pre-, intra-, and post-partum haemorrhage), comorbidities, peripartum complications, administration of blood products, and use of cell salvage were analysed. RESULTS: Of 6 356 046 deliveries in Germany, 305 610 women (4.8%) suffered from peripartum haemorrhage. Of all women with peripartum haemorrhage, postpartum haemorrhage was the main cause for major obstetric haemorrhage (92.33%). Cell salvage was used in only 228 (0.07%) of all women with peripartum haemorrhage (cell salvage group). In women undergoing Caesarean delivery with postpartum haemorrhage, cell salvage was used in only 216 out of 70 450 women (0.31%). CONCLUSION: Cell salvage during peripartum haemorrhage is rarely used in Germany. There is tremendous potential for the increased use of cell salvage in peripartum haemorrhage nationwide.
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Bases de Dados Factuais , Recuperação de Sangue Operatório , Hemorragia Pós-Parto , Humanos , Feminino , Alemanha/epidemiologia , Hemorragia Pós-Parto/terapia , Hemorragia Pós-Parto/epidemiologia , Gravidez , Estudos Retrospectivos , Adulto , Recuperação de Sangue Operatório/estatística & dados numéricos , Cesárea/estatística & dados numéricos , Transfusão de Sangue Autóloga/estatística & dados numéricos , ObstetríciaRESUMO
BACKGROUND: Diagnostic laboratory tests are an integral part of managing hospitalized patients. In particular, patients in the intensive care units (ICUs) can experience a concerning amount of blood loss due to diagnostic testing, which can increase the risk developing iatrogenic anemia. Several interventions exist to curtail avoidable blood loss, for example computerized decision support, smaller phlebotomy tubes, and other blood conservation devices. Nevertheless, use of these interventions is not standardized. Therefore, the objective of our study was to quantify the daily phlebotomy volume taken from patients who had undergone major cardiac or vascular surgery. METHODS: We estimated the number of blood analyses and volumes of drawn blood of 400 consecutive patients (≥ 18 yr) undergoing major cardiac or vascular surgery. The amount of blood saved using small-volume tubes and in combination with blood conservation device rather than standard-volume tubes was estimated for serum chemistry (serum), ethylenediaminetetraacetic acid (EDTA) tubes, sodium citrate coagulation (SCC) tubes, and arterial blood gas (ABG) analysis. RESULTS: The mean total blood loss due to phlebotomy drawing using standard-volume tubes during hospitalization was 167.9 mL (95% confidence interval [CI], 158.0 to 177.8), 255.6 mL (95% CI, 226.5 to 284.6), and 695.3 mL (95% CI, 544.1 to 846.4) for patients undergoing cardiac surgery with a hospital length of stay (LOS) of 0-10, 11-20, and ≥ 21 days, respectively. The mean total blood loss due to phlebotomy during hospitalization was 80.5 mL (95% CI, 70.5 to 90.6), 225.0 mL (95% CI, 135.1 to 314.8 mL) and 470.3 mL (95% CI, 333.5 to 607.1) for vascular surgery patients with LOS 0-10, 11-20, and ≥ 21 days, respectively. Patients with at least a two-day stay at the ICU had a mean blood loss of 146.6 mL (95% CI, 134.6 to 158.6 mL) and those with ≥ 11 days incurred a loss of 1,428 mL (95% CI, 1,117.8 to 1,739.2). The use of closed blood collection device and small-volume tubes (serum, EDTA, SCC, and ABG) reduced blood loss by 82.8 mL for patients with an ICU stay of 2 days and up to 824.0 mL for patients with a ICU stay of ≥ 11 days. CONCLUSION: Diagnostic laboratory tests are associated with significant patient blood loss, but are a modifiable risk factor. The use of small-volume tubes and closed blood collection devices decreases the volume of patient blood drawn for analysis and prevents blood waste.
RéSUMé: CONTEXTE: Les tests diagnostiques de laboratoire font partie intégrante de la prise en charge des personnes hospitalisées. Plus spécifiquement, la patientèle des unités de soins intensifs (USI) peut perdre une quantité inquiétante de sang en raison des tests de diagnostic, ce qui peut augmenter le risque d'anémie iatrogène. Plusieurs interventions existent pour réduire les pertes de sang évitables, par exemple une aide à la décision informatisée, des tubes de phlébotomie plus petits et d'autres dispositifs de conservation du sang. Néanmoins, le recours à ces interventions n'est pas normalisé. Par conséquent, l'objectif de notre étude était de quantifier le volume quotidien de phlébotomie prélevée chez des patient·es ayant bénéficié d'une chirurgie cardiaque ou vasculaire majeure. MéTHODE: Nous avons estimé le nombre d'analyses sanguines et les volumes de sang prélevés de 400 personnes consécutives (≥ 18 ans) bénéficiant d'une chirurgie cardiaque ou vasculaire majeure. La quantité de sang économisée à l'aide de tubes de petit volume et en combinaison avec un dispositif de conservation du sang plutôt que des tubes de volume standard a été estimée pour la chimie sérique (sérum), les tubes d'acide éthylène-diamine-tétra-acétique (EDTA), les tubes de coagulation au citrate de sodium (CCS) et l'analyse des gaz du sang artériel (GSA). RéSULTATS: La perte sanguine totale moyenne due au prélèvement de phlébotomie à l'aide de tubes de volume standard pendant l'hospitalisation était de 167,9 mL (intervalle de confiance [IC] à 95 %, 158,0 à 177,8), 255,6 mL (IC 95 %, 226,5 à 284,6) et 695,3 mL (IC 95 %, 544,1 à 846,4) chez les patient·es bénéficiant d'une chirurgie cardiaque avec une durée de séjour à l'hôpital de 0 à 10, 11 à 20, et ≥ 21 jours, respectivement. La perte sanguine totale moyenne due à la phlébotomie pendant l'hospitalisation était de 80,5 mL (IC 95 %, 70,5 à 90,6), 225,0 mL (IC 95 %, 135,1 à 314,8 mL) et 470,3 mL (IC 95 %, 333,5 à 607,1) chez les patient·es ayant bénéficié d'une chirurgie vasculaire avec des durées de séjour de 0-10, 11-20 et ≥ 21 jours, respectivement. Les patient·es ayant séjourné au moins deux jours à l'USI ont eu une perte de sang moyenne de 146,6 mL (IC 95 %, 134,6 à 158,6 mL) et celles et ceux ayant séjourné ≥ 11 jours ont subi une perte de 1428 mL (IC 95 %, 1117,8 à 1739,2). L'utilisation d'un dispositif de prélèvement sanguin fermé et de tubes de petit volume (sérum, EDTA, SCC et gsa) a réduit la perte de sang de 82,8 mL pour les patient·es ayant séjourné à l'USI 2 jours et jusqu'à 824,0 mL pour les patient·es ayant séjourné en USI ≥ 11 jours. CONCLUSION: Les tests de laboratoire diagnostiques sont associés à une perte de sang importante chez les patient·es, mais constituent un facteur de risque modifiable. L'utilisation de tubes de petit volume et de dispositifs fermés de prélèvement sanguin diminue le volume de sang prélevé pour analyse et prévient le gaspillage de sang.
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Hemorragia , Flebotomia , Humanos , Ácido Edético , Flebotomia/efeitos adversos , Hemorragia/etiologia , Unidades de Terapia Intensiva , Volume Sanguíneo , Procedimentos Cirúrgicos Vasculares/efeitos adversosRESUMO
PURPOSE OF REVIEW: The worldwide leading cause of maternal death is severe maternal hemorrhage. Maternal hemorrhage can be profound leading to an entire loss of blood volume. In the past two decades, Patient Blood Management has evolved to improve patient's care and safety. In surgeries with increased blood loss exceeding 500âml, the use of cell salvage is strongly recommended in order to preserve the patient's own blood volume and to minimize the need for allogeneic red blood cell (RBC) transfusion. In this review, recent evidence and controversies of the use of cell salvage in obstetrics are discussed. RECENT FINDINGS: Numerous medical societies as well as national and international guidelines recommend the use of cell salvage during maternal hemorrhage. SUMMARY: Intraoperative cell salvage is a strategy to maintain the patient's own blood volume and decrease the need for allogeneic RBC transfusion. Historically, cell salvage has been avoided in the obstetric population due to concerns of iatrogenic amniotic fluid embolism (AFE) or induction of maternal alloimmunization. However, no definite case of AFE has been reported so far. Cell salvage is strongly recommended and cost-effective in patients with predictably high rates of blood loss and RBC transfusion, such as women with placenta accreta spectrum disorder. However, in order to ensure sufficient practical experience in a multiprofessional obstetric setting, liberal use of cell salvage appears advisable.
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Recuperação de Sangue Operatório , Humanos , Gravidez , Feminino , Recuperação de Sangue Operatório/métodos , Recuperação de Sangue Operatório/efeitos adversos , Hemorragia Pós-Parto/terapia , Transfusão de Eritrócitos/métodos , Transfusão de Eritrócitos/efeitos adversos , Transfusão de Eritrócitos/normas , Transfusão de Sangue Autóloga/métodos , Transfusão de Sangue Autóloga/efeitos adversos , Transfusão de Sangue Autóloga/normas , Perda Sanguínea Cirúrgica/prevenção & controle , Embolia Amniótica/terapia , Embolia Amniótica/diagnóstico , Obstetrícia/métodos , Obstetrícia/tendências , Obstetrícia/normasRESUMO
PURPOSE OF REVIEW: Postpartum anemia (PPA) is common in women after childbirth and affects about 50-80% of all women worldwide. Iron deficiency (ID) is the main cause for anemia and constitutes a potentially preventable condition with great impact on the mother's physical and mental condition after delivery. In most cases, PPA is associated with antenatal ID and peripartum blood losses. Numerous published studies confirmed the positive effect of PPA diagnosis and treatment. RECENT FINDINGS: Iron deficiency as well as iron deficiency anemia (IDA) are common in the postpartum period and represent significant health problems in women of reproductive age. SUMMARY: Important movements towards early detection and therapy of postpartum anemia have been observed. However, postpartum anemia management is not implemented on a large scale as many healthcare professionals are not aware of the most recent findings in the field. Diagnosis and therapy of PPA, particularly iron supplementation in ID and IDA, has proven to be highly effective with a tremendous effect on women's wellbeing and outcome.
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Anemia Ferropriva , Humanos , Feminino , Anemia Ferropriva/diagnóstico , Anemia Ferropriva/terapia , Anemia Ferropriva/etiologia , Gravidez , Anemia/terapia , Anemia/diagnóstico , Anemia/etiologia , Ferro/uso terapêutico , Ferro/administração & dosagem , Período Pós-Parto , Transtornos Puerperais/terapia , Transtornos Puerperais/diagnóstico , Transtornos Puerperais/etiologia , Suplementos Nutricionais , Deficiências de Ferro/diagnóstico , Deficiências de Ferro/terapiaRESUMO
Arterial catheterization is considered to be standard procedure for patients undergoing general anesthesia. The most common puncture site is the radial artery (RA), which carries a risk of RA occlusion. Several pieces of literature still recommend the performance of the Allen test (AT) to assess the circulation of the palmar arch. However, the result of the AT differs largely depending on the examiner and the test is not able to predict ischemic events correctly. Thus it appears that the performance of an AT is not mandatory before arterial cannulation.
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Cateterismo Periférico , Artéria Radial , Humanos , Cateterismo , Mãos/irrigação sanguínea , IsquemiaRESUMO
In the early days of anaesthesia, the fasting period for liquids was kept short. By the mid-20th century 'nil by mouth after midnight' had become routine as the principles of the management of 'full stomach' emergencies were extended to include elective healthy patients. Back then, no distinction was made between the withholding of liquids and solids. Towards the end of the last century, recommendations of professional anaesthesiology bodies began to reduce the fasting time of clear liquids to 2 h. This reduction in fasting time was based on the understanding that gastric emptying of clear liquids is rapid, exponential, and proportional to the current filling state of the stomach. Furthermore, there was no evidence of a link between drinking clear liquids and the risk of aspiration. Indeed, most instances of aspiration are caused by failure to identify aspiration risk factors and adjust the anaesthetic technique accordingly. In contrast, long periods of liquid withdrawal cause discomfort and may also lead to serious postoperative complications. Despite this, more than two decades after the introduction of the 2 h limit, patients still fast for a median of up to 12 h before anaesthesia, mainly because of organisational issues. Therefore, some hospitals have decided to allow patients to drink clear liquids within 2 h of induction of anaesthesia. Well-designed clinical trials should investigate whether these concepts are safe in patients scheduled for anaesthesia or procedural sedation, focusing on both aspiration risk and complications of prolonged fasting.
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Extracellular vesicles (EVs) are small lipid bilayer vesicles released by cells to facilitate cell-to-cell communication. To study their biological roles and functions, they need to be isolated and purified, which can be achieved through a variety of methods. Here, we describe different methods for isolating and purifying EVs, with a focus on calculating the required g-force and centrifugation time with different centrifuges and rotors. We have compiled key formulas and tested predicted parameters for EV acquisitions to provide a comprehensive guide for EV isolation.
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Vesículas Extracelulares , Centrifugação , Centrifugação com Gradiente de Concentração/métodosRESUMO
The integrity of the blood-brain barrier (BBB) is essential for the normal functioning of the central nervous system (CNS). Isolated brain capillaries are essential for analyzing changes in protein and gene expression at the BBB under physiological and pathological conditions. The standard methods for isolating brain capillaries require the use of at least one or more mouse brains in order to obtain sufficient quantity and purity of brain capillaries. Here, we describe an optimized protocol for isolating and purifying capillaries from tiny amounts of mouse cerebral cortex using manual homogenization, density gradient centrifugation, and filtration while preserving the structural integrity and functional activity of microvessel fragments. Western blotting showed that proteins expressed at the BBB were enriched in mouse brain capillaries isolated by the optimized method compared to cerebral cortex protein homogenates. This approach can be used for the analysis of a variety of rare mouse genetic models and can also help the investigators to understand regional differences in susceptibility to pathological phenomena such as ischemia and traumatic brain injury. This will allow the investigators to better understand the physiology and pathology of the BBB.
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Encéfalo , Capilares , Camundongos , Animais , Capilares/metabolismo , Encéfalo/metabolismo , Barreira Hematoencefálica/metabolismo , Proteínas/metabolismo , Transporte BiológicoRESUMO
OBJECTIVE: Chemical, biological, radiological, and nuclear (CBRN) incidents are a major challenge for emergency medical services and the involved hospitals, especially if decontamination needs to be performed nearby or even within the hospital campus. The University Hospital Wuerzburg has developed a comprehensive and alternative CBRN response plan. The focus of this study was to proof the practicability of the concept, the duration of the decontamination process, and the temperature management. METHODS: The entire decontamination area can be deployed 24/7 by the hospitals technical staff. Fire and rescue services are responsible for the decontamination process itself. This study was designed as full-scale exercise with 30 participants. RESULTS: The decontamination area was ready for operation within 30 minutes. The decontamination of the four simulated patients took 5.5 ± 0.6 minutes (mean ± SD). At the end of the decontamination process, the temperature of the undressed upper body of the training patients was 27.25 ± 1°C (81.05 ± 2°F) (mean ± SD) and the water in the shower was about 35°C (95°F). CONCLUSION: The presented concept is comprehensive and simple for a best possible care during CBRN incidents at hospitals. It ensures wet decontamination by Special Forces, while the technical requirements are created by the hospital.
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Planejamento em Desastres , Serviços Médicos de Emergência , Incidentes com Feridos em Massa , Humanos , Projetos Piloto , Hospitais Universitários , DescontaminaçãoRESUMO
Background: Handovers during medical emergencies are challenging due to time-critical, dynamic and oftentimes unorderly and distracting situations. We evaluated the effect of distraction-reduced clinical surroundings during handover on (1) the recall of handover information, (2) the recall of information from the surroundings and (3) self-reported workload in a simulated in-hospital cardiac arrest scenario. Methods: In a parallel group design, emergency team leaders were randomly assigned to receive a structured handover of a cardio-pulmonary resuscitation (CPR) either inside the room ("inside group") right next to the ongoing CPR or in front of the room ("outside group") with no audio-visual distractions from the ongoing CPR. Based on the concept of situation awareness, the primary outcome was a handover score for the content of the handover (0-19 points) derived from the pieces of information given during handover. Furthermore, we assessed team leaders' perception of their surroundings during the scenario (0-5 points) and they rated their subjective workload using the NASA Task Load Index. Results: The outside group (n = 30) showed significant better recall of handover information than the inside group (n = 30; mean difference = 1.86, 95% CI = 0.67 to 3.06, p = 0.003). The perception of the surroundings (n = 60; mean difference = -0.27, 95% CI = -0.85 to 0.32, p = 0.365) and the NASA Task Load Index (n = 58; mean difference = 1.1; p = 0.112) did not differ between the groups. Conclusions: Concerning in-hospital emergencies, a structured handover in a distraction reduced environment can improve information uptake of the team leader.
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INTRODUCTION: The perioperative cardiovascular management of patients undergoing noncardiac surgery is particularly challenging in those with pre-existing heart failure (HF). This study was designed to evaluate the effectiveness of nurse-based pre- and postoperative specialized HF management in reducing postoperative HF-associated complications in patients with known HF undergoing noncardiac surgery. METHODS: This prospective, randomized pilot study included patients with established HF requiring intermediate- to high-risk noncardiac surgery. Patients received postoperatively either standard care (control group, CG) or nurse-supported HF management (intervention group, IG). The primary endpoint was a composite of HF-related postoperative complications at 30 days. Secondary endpoints included length on intensive care unit, length of hospital stay, death, hospitalization for HF, and quality of life assessment using the SF-12 questionnaire. RESULTS: The trial was halted prematurely for futility. A total of 34 patients (median age 70.5 [IQR 67-75] years; with 15 HfpEF, 9 HfmrEF,10 HfrEF), with an average NT-proBNP of 1.413 [463-2.832] pg/mL were included. The IG had a lower rate of postoperative primary events (25%; n = 4) compared with the CG (33%; n = 6). There were no differences in secondary endpoints between the groups. Quality-of-life scores improved slightly in both groups (δ 5.6 ± 0.9 [CG] and 3.1 ± 1.2 [IG]). CONCLUSION: Nurse-based pre- and postoperative HF care appears to be feasible and may reduce HF-associated complications in patients undergoing noncardiac surgery. Larger clinical trials are needed to further evaluate the effectiveness of this approach in reducing postoperative complications in this high-risk patient population.
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Estudos de Viabilidade , Insuficiência Cardíaca , Complicações Pós-Operatórias , Qualidade de Vida , Humanos , Projetos Piloto , Feminino , Masculino , Idoso , Estudos Prospectivos , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento , Cuidados Pós-Operatórios/métodos , Cuidados Pré-Operatórios/métodos , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Fatores de Tempo , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Thromboembolic events are common complications of COVID-19. Clinical study results on safety and efficacy of anticoagulation in COVID-19 are controversial. MATERIAL AND METHODS: This report is the second update of our systematic review with meta-analysis on randomized controlled trials (RCTs) comparing standard thromboprophylaxis, intermediate or therapeutic dose anticoagulation or no anticoagulation in COVID-19 in- and outpatients. We searched eligible studies up to 5 October 2023. Certainty of evidence was assessed using GRADE. RESULTS: For this update we included fourteen new RCTs and a total of 27 RCTs with 16,789 patients. Certainty of evidence ranged from very low to high depending on outcome and comparison. Standard thromboprophylaxis with low dose anticoagulation may have little or no effect for COVID-19 outpatients compared to no anticoagulation. In inpatients with moderate or severe COVID-19, intermediate dose anticoagulation may decrease any thrombotic events or death, but may increase major bleeding compared to standard thromboprophylaxis. Therapeutic dose anticoagulation decreases thrombotic events or deaths in inpatients with moderate COVID-19, but probably has little or no effect in patients with severe COVID-19 compared to standard thromboprophylaxis with low or intermediate dose anticoagulation. With therapeutic dose anticoagulation, the risk of major bleeding probably increases regardless of COVID-19 severity. We are uncertain on the effect of thromboprophylaxis with low dose anticoagulation compared to no anticoagulation in the post-discharge setting. CONCLUSIONS: Hospitalized, moderately-ill COVID-19 patients may benefit from intermediate or therapeutic dose anticoagulation, while critically ill patients may not. Risk of major bleeding must be considered.
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Anticoagulantes , COVID-19 , Humanos , Anticoagulantes/uso terapêutico , COVID-19/complicações , SARS-CoV-2 , Hemorragia/induzido quimicamente , Tratamento Farmacológico da COVID-19 , Ensaios Clínicos Controlados Aleatórios como Assunto , Tromboembolia/prevenção & controle , Tromboembolia/etiologiaRESUMO
Anemia affects humans throughout life, and is linked to higher morbidity and mortality. Unclear is whether hemoglobin values are equivalent between women and men. This study evaluates the association of preoperative hemoglobin levels with in-hospital mortality and estimates thresholds for survival equity between men and women. All adult patients undergoing surgery between 2010 and 2019 from 14 German hospitals were included in the study. Thresholds for survival equity were determined with generalized additive models. In total, 842,130 patients with a median in-hospital follow-up time of 7 days were analyzed. During follow-up 20,370 deaths occurred. Preoperative hemoglobin stratified in-hospital mortality (log-rank test p < 0.001) and was associated with mortality independently of demographic risk, surgical risk and health status. For each 1 g/dL reduction in preoperative hemoglobin, the odds of mortality increased by a factor of 1.22 (95% CI 1.21-1.23, p < 0.001). A preoperative hemoglobin threshold of 10.5 g/dL reflected equivalent risk for both male and female patients. Hemoglobin levels below 10.5 g/dL had higher risk of mortality for women than for men. The findings from this study aid evidence-based thresholds, inform anemia management and promote equitable care, thus enhancing patient outcomes.
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Background/Objective: In the perioperative setting, a suboptimal total hemoglobin (Hb) mass puts women and men at an unreasonable disadvantage. Anemia is an independent risk factor for transfusion, postoperative complications, and mortality. The Hb cut-off value for women was set at <12.0 g/dL by the World Health Organization (WHO) and has been rigorously debated for decades. The aim of this study was to elucidate the risk for postoperative complications in female patients with Hb levels < 12.0, 12.0-12.9, and ≥13.0 g/dL. Material and Methods: Single-center retrospective analysis of female patients undergoing major surgery. Results: In total, 6,516 patients ≥18 years of age had major surgery between 2018 and 2019 and 2,446 female patients were included in analysis. Mean age was 67.4 ± 16.6, 66.4 ± 15.6, and 64.5 ± 15.5 years in female patients with preoperative Hb levels <12.0, 12.0-12.9 and ≥13.0 g/dL, respectively. The transfusion rate of red blood cells (RBCs) was significantly higher in female patients with Hb <12.0 g/dL (53%) and with Hb 12.0-12.9 g/dL (31%) compared to female patients ≥13.0 g/dL (22%). Rates of pneumonia, acute kidney injury, and sepsis were significantly higher in patients with Hb <12.0 and 12.0-12.9 g/dL compared to patients with Hb ≥13.0 g/dL. Total length of hospital stay was significantly longer in female patients with Hb <12.0 g/dL than patients with Hb 12.0-12.9 g/dL and Hb ≥13.0 g/dL (10 days vs. 8 days). Conclusion: Taken together, our data show that Hb values below 12.9 g/dL are associated with increased probability of RBC transfusions and increased risk of postoperative complications. In addition, our results indicate that postoperative outcomes for women might be optimized by increasing cut-off values for anemia. The call to revise the anemia threshold for women by the WHO can no longer be disregarded.
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Anemia , Hemoglobinas , Complicações Pós-Operatórias , Humanos , Feminino , Estudos Retrospectivos , Pessoa de Meia-Idade , Hemoglobinas/análise , Idoso , Complicações Pós-Operatórias/epidemiologia , Fatores de Risco , Idoso de 80 Anos ou mais , Transfusão de Eritrócitos/estatística & dados numéricos , Transfusão de Sangue/estatística & dados numéricos , Adulto , Tempo de Internação/estatística & dados numéricosRESUMO
BACKGROUND AND AIMS: Despite recent advancements in medical and surgical techniques in patients suffering from Crohn`s Disease (CD), postoperative morbidity remains relevant due to a long-standing, non-curable disease burden. As demonstrated for oncological patients, perioperative enhanced recovery concepts provide great potential to improve postoperative outcome. However, robust evidence about the effect of perioperative enhanced recovery concepts in the specific cohort of CD patients is lacking. METHODS: In a prospective single-center study, all patients receiving ileocecal resection due to CD between 2020 and 2023 were included. A specific perioperative enhanced recovery concept (ERC) was implemented and patients were divided into two groups (before and after implementation). The primary outcome focused on postoperative complications as measured by the Comprehensive Complication Index (CCI), secondary endpoints were severe complications, length of hospital stay, and rates of re-admission. RESULTS: 83 patients were analyzed of which 33 patients participated in the enhanced recovery program (postERC). While patient characteristics were comparable between both groups, ERC resulted in significantly decreased rates of overall and severe postoperative complications (CCI: 21.4 versus 8.4, p=0.0036; Clavien Dindo >2: 38% versus 3.1%, p=0.0002). Additionally, postERC-patients were earlier ready for discharge (6.5 days versus 5 days, p=0.001) and rates of re-admission were significantly lower (20% versus 3.1%, p=0.03). In a multivariate analysis, the recovery concept was identified as independent factor to reduce severe postoperative complications (p=0.019). CONCLUSION: A specific perioperative enhanced recovery concept significantly improves the postoperative outcome of patients suffering from Crohn`s Disease.
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BACKGROUND: Iron deficiency (ID) is the leading cause of anemia worldwide. The prevalence of preoperative ID ranges from 23 to 33%. Preoperative anemia is associated with worse outcomes, making it important to diagnose and treat ID before elective surgery. Several studies indicated the effectiveness of intravenous iron supplementation in iron deficiency with or without anemia (ID(A)). However, it remains challenging to establish reliable evidence due to heterogeneity in utilized study outcomes. The development of a core outcome set (COS) can help to reduce this heterogeneity by proposing a minimal set of meaningful and standardized outcomes. The aim of our systematic review was to identify and assess outcomes reported in randomized controlled trials (RCTs) and observational studies investigating iron supplementation in iron-deficient patients with or without anemia. METHODS: We searched MEDLINE, CENTRAL, and ClinicalTrials.gov systematically from 2000 to April 1, 2022. RCTs and observational studies investigating iron supplementation in patients with a preoperative diagnosis of ID(A), were included. Study characteristics and reported outcomes were extracted. Outcomes were categorized according to an established outcome taxonomy. Quality of outcome reporting was assessed with a pre-specified tool. Reported clinically relevant differences for sample size calculation were extracted. RESULTS: Out of 2898 records, 346 underwent full-text screening and 13 studies (five RCTs, eight observational studies) with sufficient diagnostic inclusion criteria for iron deficiency with or without anemia (ID(A)) were eligible. It is noteworthy to mention that 49 studies were excluded due to no confirmed diagnosis of ID(A). Overall, 111 outcomes were structured into five core areas including nine domains. Most studies (92%) reported outcomes within the 'blood and lymphatic system' domain, followed by "adverse event" (77%) and "need for further resources" (77%). All of the latter reported on the need for blood transfusion. Reported outcomes were heterogeneous in measures and timing. Merely, two (33%) of six prospective studies were registered prospectively of which one (17%) showed no signs of selective outcome reporting. CONCLUSION: This systematic review comprehensively depicts the heterogeneity of reported outcomes in studies investigating iron supplementation in ID(A) patients regarding exact definitions and timing. Our analysis provides a systematic base for consenting to a minimal COS. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020214247.
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Anemia Ferropriva , Anemia , Deficiências de Ferro , Humanos , Anemia Ferropriva/tratamento farmacológico , Anemia Ferropriva/prevenção & controle , Ferro/uso terapêutico , Medidas de Resultados Relatados pelo PacienteRESUMO
Objective: Postoperative pulmonary embolism (PE) is a rare but potentially life-threatening complication, which can be treated with extracorporeal membrane oxygenation (ECMO) therapy, a novel therapy option for acute cardiorespiratory failure. We postulate that hospitals with ECMO availability have more experienced staff, technical capabilities, and expertise in treating cardiorespiratory failure. Design: A retrospective analysis of surgical procedures in Germany between 2012 and 2019 was performed using hospital billing data. High-risk surgical procedures for postoperative PE were analyzed according to the availability of and expertise in ECMO therapy and its effect on outcome, regardless of whether ECMO was used in patients with PE. Methods: Descriptive, univariate, and multivariate analyses were applied to identify possible associations and correct for confounding factors (complications, complication management, and mortality). Results: A total of 13,976,606 surgical procedures were analyzed, of which 2,407,805 were defined as high-risk surgeries. The overall failure to rescue (FtR) rate was 24.4% and increased significantly with patient age, as well as type of surgery. The availability of and experience in ECMO therapy (defined as at least 20 ECMO applications per year; ECMO centers) are associated with a significantly reduced FtR in patients with PE after high-risk surgical procedures. In a multivariate analysis, the odds ratio (OR) for FtR after postoperative PE was significantly lower in ECMO centers (OR, 0.75 [0.70-0.81], P < 0.001). Conclusions: The availability of and expertise in ECMO therapy lead to a significantly reduced FtR rate of postoperative PE. This improved outcome is independent of the use of ECMO in these patients.
RESUMO
INTRODUCTION: Sepsis remains the major cause of death among hospitalised patients in intensive care. While targeting sepsis-causing pathogens with source control or antimicrobials has had a dramatic impact on morbidity and mortality of sepsis patients, this strategy remains insufficient for about one-third of the affected individuals who succumb. Pharmacological targeting of mechanisms that reduce sepsis-defining organ dysfunction may be beneficial. When given at low doses, the anthracycline epirubicin promotes tissue damage control and lessens the severity of sepsis independently of the host-pathogen load by conferring disease tolerance to infection. Since epirubicin at higher doses can be myelotoxic, a first dose-response trial is necessary to assess the potential harm of this drug in this new indication. METHODS AND ANALYSIS: Epirubicin for the Treatment of Sepsis and Septic Shock-1 is a randomised, double-blind, placebo-controlled phase 2 dose-escalation phase IIa clinical trial to assess the safety of epirubicin as an adjunctive in patients with sepsis. The primary endpoint is the 14-day myelotoxicity. Secondary and explorative outcomes include 30-day and 90-day mortality, organ dysfunction, pharmacokinetic/pharmacodynamic (PK/PD) and cytokine release. Patients will be randomised in three consecutive phases. For each study phase, patients are randomised to one of the two study arms (epirubicin or placebo) in a 4:1 ratio. Approximately 45 patients will be recruited. Patients in the epirubicin group will receive a single dose of epirubicin (3.75, 7.5 or 15 mg/m2 depending on the study phase. After each study phase, a data and safety monitoring board will recommend continuation or premature stopping of the trial. The primary analyses for each dose level will report the proportion of myelotoxicity together with a 95% CI. A potential dose-toxicity association will be analysed using a logistic regression model with dose as a covariate. All further analyses will be descriptive. ETHICS AND DISSEMINATION: The protocol is approved by the German Federal Institute for Drugs and Medical Devices. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05033808.
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Epirubicina , Sepse , Choque Séptico , Adulto , Feminino , Humanos , Masculino , Ensaios Clínicos Fase II como Assunto , Relação Dose-Resposta a Droga , Método Duplo-Cego , Epirubicina/administração & dosagem , Epirubicina/efeitos adversos , Epirubicina/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Sepse/tratamento farmacológico , Choque Séptico/tratamento farmacológicoRESUMO
(1) Background: The clinical management of anticoagulated patients treated with direct oral anticoagulants (DOAC) or Vitamin K antagonists (VKA) needing emergency surgery is challenging. (2) Methods: The prospective German RADOA registry investigated treatment strategies in DOAC- or VKA-treated patients needing emergency surgery within 24 h after admission. Effectiveness was analysed by clinical endpoints including major bleeding. Primary observation endpoint was in hospital mortality until 30 days after admission. (3) Results: A total of 78 patients were included (DOAC: 44; VKA: 34). Median age was 76 years. Overall, 43% of the DOAC patients and 79% of the VKA patients were treated with prothrombin complex concentrates (PCC) (p = 0.002). Out of the DOAC patients, 30% received no hemostatic treatment compared to 3% (1/34) of the VKA patients (p = 0.002), and 7% of the DOAC patients and 21% of the VKA patients developed major or clinically relevant non-major bleeding at the surgical site (p = 0.093). In-hospital mortality was 13% with no significant difference between the two treatment groups (DOAC: 11%, VKA: 15%; p > 0.20). (4) Conclusions: The 30-day in-hospital mortality rate was comparable between both patient groups. VKA patients required significantly more hemostatic agents than DOAC patients in the peri- and postoperative surgery period.