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BACKGROUND AND OBJECTIVE: Probiotics show promise in inflammatory bowel disease (IBD), yet knowledge gaps persist. We performed an overview of systematic reviews and an updated metanalysis of randomized controlled trials (RCT) assessing the effect of probiotics on Crohn's disease (CD) and ulcerative colitis (UC). METHODS: MEDLINE, Web of Science, and the Cochrane Central Register of Controlled Trials were searched up to September 2023. Primary outcomes were clinical remission and recurrence; secondary outcomes included endoscopic response and remission, and adverse events. We calculated odds ratios (OR) using a random-effects model in R. The quality of systematic reviews was assessed using the AMSTAR-2; the trials' risk of bias was evaluated using the Cochrane Collaboration tool. Evidence certainty was rated using the GRADE framework. RESULTS: Out of 2613 results, 67 studies (22 systematic reviews and 45 RCTs) met the eligibility criteria. In the updated meta-analysis, the OR for clinical remission in UC and CD was 2.00 (95% CI 1.28-3.11) and 1.61 (95% CI 0.21-12.50), respectively. The subgroup analysis suggested that combining 5-ASA and probiotics may be beneficial for inducing remission in mild-to-moderate UC (OR 2.35, 95% CI 1.29-4.28). Probiotics decreased the odds of recurrence in relapsing pouchitis (OR 0.03, 95% CI 0.00-0.25) and trended toward reducing clinical recurrence in inactive UC (OR 0.65, 95% CI 0.42-1.01). No protective effect against recurrence was identified for CD. Multi-strain formulations appear superior in achieving remission and preventing recurrence in UC. The use of probiotics was not associated with better endoscopic outcomes. Adverse events were similar to control. However, the overall certainty of evidence was low. CONCLUSION: Probiotics, particularly multi-strain formulations, appear efficacious for the induction of clinical remission and the prevention of relapse in UC patients as well as for relapsing pouchitis. Notwithstanding, no significant effect was identified for CD. The favorable safety profile of probiotics was also highlighted.
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BACKGROUND/OBJECTIVES: The escalating obesity epidemic necessitates effective, sustainable weight loss (WL) and maintenance strategies. This study aimed to evaluate the effectiveness of the Weight Loss Maintenance 3 Phases Program (WLM3P) in achieving a clinically significant long-term weight loss (WL) (≥5% initial WL at 18 months) in adults with obesity compared to a standard low-carbohydrate diet (LCD). SUBJECTS/METHODS: In this two-phase trial, 112 participants targeting initial WL (0-6 months) and subsequent maintenance (7-18 months) were randomly assigned to either WLM3P or LCD groups. Outcomes assessed included change in body weight (kg, %), improvements in body composition, and metabolic profile. RESULTS: Of 112 randomized participants, 69% (n = 77) completed the study. At 18 months, WL in the WLM3P group (n = 40) was 15.5 ± 8.3% compared to 9.6 ± 8.5% in the LCD group (n = 37) (p < 0.001). The odds ratio of achieving WL ≥ 10% and ≥15% were significantly higher in the WLM3P group. Complete-case analysis revealed significantly greater improvements in BMI, body fat mass, visceral fat area, waist circumference, waist-to-hip ratio, HDL, and triglyceride/HDL ratio in WLM3P than in LCD. No serious adverse events were reported. CONCLUSION: Both programs effectively promoted clinically relevant WL and its maintenance. However, the WLM3P program was more successful in helping participants achieve greater WL targets of ≥10% and ≥15%, along with other clinical benefits, after an 18-month intervention. TRIAL REGISTRATION NUMBER: NCT04192357.
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Obesidad , Pérdida de Peso , Programas de Reducción de Peso , Humanos , Masculino , Femenino , Obesidad/terapia , Obesidad/dietoterapia , Adulto , Persona de Mediana Edad , Programas de Reducción de Peso/métodos , Composición Corporal , Dieta Baja en Carbohidratos/métodos , Índice de Masa Corporal , Resultado del Tratamiento , Circunferencia de la CinturaRESUMEN
INTRODUCTION AND OBJECTIVES: The use of loop diuretics is central in managing congestion in heart failure (HF), but their impact on prognosis remains unclear. In euvolemic patients, dose reduction is recommended, but there is no recommendation on their discontinuation. This study aims to assess the impact of loop diuretic discontinuation on the prognosis of outpatients with HF with reduced ejection fraction. METHODS: This retrospective cohort study collected data from medical records of patients followed in an outpatient HF clinic at a university hospital center. Patients were included if they had been on loop diuretics and these were discontinued. Demographic, clinical and laboratory data were collected, and number and type of congestive events during the one-year period after discontinuation were recorded. RESULTS: Among 265 patients on loop diuretics, almost half (129) discontinued them at some point. Patients had optimized medical therapy, low median age, low New York Heart Association class, low B-type natriuretic peptide values, normal blood pressure, controlled heart rate and kidney function within normal limits. Among 122 patients with one year of follow-up, 18 (14.8%) had a congestive event. Fifteen events (83.3%) were low-dose diuretic reinitiation at a scheduled visit. There were only three worsening heart failure events (2.5%) during the one-year period. A significant improvement in kidney function from discontinuation to the one-year follow-up appointment was also observed. CONCLUSIONS: In our cohort, loop diuretic discontinuation was possible and safe in a large proportion of patients. The results should be interpreted with caution and cannot be extrapolated to a broader population of HF patients.
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Human papillomavirus (HPV) is the most prevalent sexually transmitted infection among young women. Notably, more than ten years after the introduction of HPV vaccination programs in Europe, it is essential to review the real-world evidence of the incidence of anogenital warts (GWs) among women vaccinated during childhood. In this systematic review, three databases were searched for studies published between January 2008 and September 2023. Nine cohort studies were included. A total of 890,320 HPV-vaccinated women and 1,922,033 unvaccinated women were evaluated. All the studies but one investigated the 4vHPV vaccine. The incidence rate of GWs in vaccinated women ranged from 0.0 to 1650 per 100,000 person-years. The highest incidence rates were found in women vaccinated with one dose at the age of 17-19 years old and in fully vaccinated women only after 19 years of age. Similar incidence values were reported among unvaccinated women. The incidence of GWs was lower when the age at first dose was 9-11 years old. This systematic review reveals that the incidence of GWs among HPV-vaccinated women is related to the age of vaccination and the number of vaccine doses received. In the post-vaccination era, epidemiological surveillance of the incidence of GWs and their genotypes is crucial.
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Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiac disease. Recently, a connection has been observed between the presence of first-degree atrioventricular block (FDAVB) and cardiovascular outcomes, although the pathophysiology of this association remains poorly understood. Considering the period 2000-2023, we retrospectively included HCM patients at sinus rhythm at the first appointment and sought possible interactions of FDAVB (defined as PR interval >200 ms) with different clinical and imaging variables and with the occurrence of cardiovascular events, including atrial fibrillation (AF). A total of 97 patients were included, of whom 57 (58.8%) were men, with a mean age of 51±19 years, and 14 (14.4%) had FDAVB. During a median of 4.29 (P25 1.92, P75 7.67) years of follow-up, 35 cardiovascular events occurred, including 13 de novo diagnoses of AF, 8 hospitalizations due to heart failure, 8 new-onset strokes, 4 myocardial infarctions, and 2 implantations of cardio defibrillators in secondary prevention; no HCM-related death occurred. We did not find any association between outcomes and the presence of FDAVB. The role of FDAVB as a prognostic marker in HCM patients requires further investigation. We found that FDAVB patients were older, more frequently reported dyspnea, had a larger QRS duration, a higher E/e' ratio, and lower maximal left ventricle wall thickness by magnetic resonance (p<0.05). After multivariable analysis, FDAVB was independently associated with a higher echocardiographic E/e' ratio (p=0.039) (odds ratio=1.588). This is the first paper to document an independent association between FGAVB and a higher E/e' ratio in HCM patients.
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Antibacterianos , Infecciones Comunitarias Adquiridas , Mortalidad Hospitalaria , Neumonía , Humanos , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Infecciones Comunitarias Adquiridas/tratamiento farmacológico , Infecciones Comunitarias Adquiridas/mortalidad , Masculino , Anciano , Femenino , Neumonía/mortalidad , Neumonía/tratamiento farmacológico , Persona de Mediana Edad , Anciano de 80 o más Años , Factores de Tiempo , Estudios Retrospectivos , Esquema de MedicaciónRESUMEN
PURPOSE: This study assessed medication patterns for inpatients at a central hospital in Portugal and explored their relationships with clinical outcomes in COVID-19 cases. METHODS: A retrospective study analyzed inpatient medication data, coded using the Anatomical Therapeutic Chemical classification system, from electronic patient records. It investigated the association between medications and clinical severity outcomes such as ICU admissions, respiratory/circulatory support needs, and hospital discharge status, including mortality (identified by ICD-10-CM/PCS codes). Multivariate analyses incorporating demographic data and comorbidities were used to adjust for potential confounders and understand the impact of medication patterns on disease progression and outcomes. RESULTS: The analysis of 2688 hospitalized COVID-19 patients (55.3% male, average age 62.8 years) revealed a significant correlation between medication types and intensity and disease severity. Cases requiring ICU admission or ECMO support often involved blood and blood-forming organ drugs. Increased use of nervous system and genitourinary hormones was observed in nonsurvivors. Corticosteroids, like dexamethasone, were common in critically ill patients, while tocilizumab was used in ECMO cases. Medications for the alimentary tract, metabolism, and cardiovascular system, although widely prescribed, were linked to more severe cases. Invasive mechanical ventilation correlated with higher usage of systemic anti-infectives and musculoskeletal medications. Trends in co-prescribing blood-forming drugs with those for acid-related disorders, analgesics, and antibacterials were associated with intensive interventions and worse outcomes. CONCLUSIONS: The study highlights complex medication regimens in managing severe COVID-19, underscoring specific drug patterns associated with critical health outcomes. Further research is needed to explore these patterns.
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COVID-19 , Pacientes Internos , Humanos , Masculino , Persona de Mediana Edad , Femenino , Estudios Retrospectivos , Antibacterianos , Utilización de MedicamentosRESUMEN
Introdução: A Atenção Básica em Saúde (AB) tem papel importante no cuidado de usuários com Covid-19, na prevenção de agravos, na escuta e acolhimento inicial, diagnósticos, condutas e encaminhamentos precoces, bem como na reabilitação e continuidade do cuidado de pessoas com sequelas da doença, tanto no âmbito físico, psíquico e social. No Brasil, embora as condutas de gestão de crise política possam ter tido impacto direto no descontrole da pandemia e com enormes quantidades de usuários em estado grave de contaminação com número elevado de óbitos, a AB possui equipes multiprofissionais que incluem o fisioterapeuta para o cuidado da população, com papel preponderante no enfrentamento da pandemia. Objetivos: Dessa forma, este ensaio acadêmico busca trazer à cena a atuação de fisioterapeutas na AB para prevenção, promoção, cuidado continuado, ações territoriais e reabilitação de usuários com Covid-19, bem como suas consequências biopsicossociais, com enfoque na integralidade do cuidado e ações coletivas no território. Métodos: Apresentamos as possibilidades de ferramentas, ações e práticas de atuação do profissional fisioterapeuta no enfrentamento da pandemia na Atenção Básica. Resultados e Conclusões: O fisioterapeuta da Atenção Básica tem um papel preponderante em todas as fases da pandemia da Covid-19, desde a promoção da saúde e prevenção de contaminação e de contágio, tratamento na fase aguda e o cuidado na Covid Longa.
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PURPOSE: To develop, implement and assess the results of psychoeducation to improve the QoL of parents with CHD newborns. METHODS: Participants were parents of inpatient newborns with the diagnosis of non-syndromic CHD. We conducted a parallel RCT with an allocation ratio of 1:1 (intervention vs. control), considering the newborns, using mixed methods research. The intervention group received psychoeducation (Parental Psychoeducation in CHD [PPeCHD]) and the usual routines, and the control group received just the regular practices. The allocation concealment was assured. PI was involved in enrolling participants, developing and implementing the intervention, data collection and data analysis. We followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines. RESULTS: Parents of eight newborns were allocated to the intervention group (n = 15 parents) and eight to the control group (n = 13 parents). It was performed as an intention-to-treat (ITT) analysis. In M2 (4 weeks), the intervention group presented better QoL levels in the physical, psychological, and environmental domains of World Health Organization Quality of Life instrument (WHOQOL-Bref). In M3 (16 weeks), scores in physical and psychological domains maintained a statistically significant difference between the groups. CONCLUSIONS: The PPeCHD, the psychoeducational intervention we developed, positively impacted parental QoL. These results support the initial hypothesis. This study is a fundamental milestone in this research field, adding new essential information to the literature.
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Cardiopatías Congénitas , Calidad de Vida , Recién Nacido , Niño , Humanos , Calidad de Vida/psicología , Padres/psicología , Cardiopatías Congénitas/psicologíaRESUMEN
BACKGROUND: Workplace gender-based mistreatment (GBM) refers to negative or harmful behaviors directed towards employees. In healthcare settings, this can lead to job dissatisfaction and underperformance and potentially compromise patient outcomes. The aim of this study was to examine workplace GBM among European anesthesiologists and produce the first European Gender-based Mistreatment Rank in Anesthesiology. METHODS: We conducted a secondary analysis from a worldwide cross-sectional survey database consisting of a 46-item questionnaire exploring, among other outcomes, gender bias attributable to workplace attitudes. The survey completion rate was 80.8%. All respondents were selected from European countries. Associations between mistreatment and the remaining variables were analyzed using univariate and multivariate logistic regression analyses. A generalized linear mixed model was then used to quantify the impact of mistreatment in each European country. Statistical significance was set at P < 0.05. RESULTS: This study included 5,795 respondents from 43 European countries. The independent predictors of GBM were as follows: female gender, younger age, perceiving gender as a disadvantage for leadership, and perceiving gender as a disadvantage for research. The full model was statistically significant, indicating an ability to distinguish between those who experienced GBM and those who did not (P < 0.001). Thus, 26 European countries were ranked based on the prevalence of mistreatment, with Italy showing the best performance (lowest prevalence). CONCLUSIONS: The aim of our study was to provide preliminary insight into GBM in anesthesiology in Europe, function as a key benchmark for gender equity, and chart the evolution of disparities over time.
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Anestesiólogos , Sexismo , Humanos , Masculino , Femenino , Estudios Transversales , Lugar de Trabajo , Análisis de RegresiónRESUMEN
BACKGROUND: The transmission of diseases by blood products continues to be a worldwide health problem, especially in Africa. Seroprevalence rates of the Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV), Syphilis, and Coinfection in Angola are poorly documented. This study aims to identify the seroprevalence of markers with positive results for Hepatitis B, C, HIV, Syphilis, and Coinfection in blood donors. MATERIAL AND METHODS: A retrospective study was conducted using a database of positive serological markers for these infections and coinfection in 2734 blood donors traced from 2011 to 2016 in Luanda, Angola. The Chi-Square test (χ2) or Fisher's exact test was used to evaluate serological positivity and donors' characteristics. A p-value < 0.05 was considered statistically significant. RESULTS: 2734 blood donors aged 18 to 64 (median age 32 ± 9) were screened from 2011 to 2016. 73.9 % of the donors were positive for one Transfusion-Transmitted Infection (TTI), and 5.9 % showed evidence of multiple infections. The overall seroprevalence rate was 50.2 % (1373) for HBV, 20 % (436) for Syphilis, 7 % (191) for HIV, 5.1 % (140) for HCV, and 5.8 % for coinfected donors. 2467 (90 %) were men, and 267 (10 %) were women. We identified 118 (5.8 %) coinfected donors. Of those, 40 (33.9 %) simultaneously presented Hepatitis B virus surface antigen (HBsAg)/Syphilis, 24 (20.3 %) HBsAg/HIV, 22 (18.6 %) HBsAg/HCV, 20 (16.9 %) HIV/Syphilis, 8 (6.8 %) HCV/Syphilis, and 4 (3.4 %) HIV/HCV. CONCLUSION: A high transfusion-transmissible infection prevalence was found compared to some countries in Sub-Saharan Africa. Therefore, intensifying the screening for these transfusion-transmitted infections in blood donors is critical to ensure blood safety.
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Coinfección , Infecciones por VIH , Hepatitis B , Hepatitis C , Sífilis , Masculino , Humanos , Femenino , Adulto Joven , Adulto , Hepacivirus , Sífilis/epidemiología , VIH , Antígenos de Superficie de la Hepatitis B , Estudios Seroepidemiológicos , Donantes de Sangre , Angola/epidemiología , Coinfección/epidemiología , Estudios Retrospectivos , Voluntarios Sanos , Hepatitis C/diagnóstico , Hepatitis B/epidemiología , Virus de la Hepatitis BRESUMEN
BACKGROUND: The emergence of new treatments the inflammatory bowel diseases (IBD) raised questions regarding the role of older agents, namely thiopurines. AIMS: To clarify the benefits of combination treatment with thiopurines on Crohn's disease (CD) patients in the maintenance phase of infliximab. METHODS: In this analysis of the 2-year prospective multicentric DIRECT study, patients were assessed in terms of clinical activity, faecal calprotectin (FC), C-reactive protein (CRP), and infliximab pharmacokinetics. A composite outcome based on clinical- and drug-related items was used to define treatment failure. RESULTS: The study included 172 patients; of these, 35.5 % were treated with combination treatment. Overall, 18 % of patients achieved the composite outcome, without statistically significant differences between patients on monotherapy and on combination treatment (21.6% vs 11.5 %, p = 0.098). Median CRP, FC, and infliximab pharmacokinetic parameters were similar in both groups. However, in the sub-analysis by infliximab treatment duration, in patients treated for less than 12 months, the composite outcome was reached in fewer patients in the combination group than in the monotherapy group (7.1% vs 47.1 %, p = 0.021). CONCLUSION: In CD patients in maintenance treatment with infliximab, combination treatment does not seem to have benefits over infliximab monotherapy beyond 12 months of treatment duration.
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Cobalt (Co), copper (Cu), manganese (Mn), molybdenum (Mo), and zinc (Zn) are essential trace elements (ETEs) and important cofactors for intermediary metabolism or redox balance. These ETEs are crucial during pregnancy, their role on specific pregnancy outcomes is largely unknown. This prospective study (#NCT04010708) aimed to assess urinary levels of these ETEs in pregnancy and to evaluate their association with pregnancy outcomes. First trimester pregnant women of Porto and Lisbon provided a random spot urine sample, and sociodemographic and lifestyle data. Clinical data were obtained from clinical records. Urinary ETEs were quantified by inductively coupled plasma mass spectrometry (ICP-MS). A total of 635 mother:child pairs were included. Having urinary Zn levels above the 50th percentile (P50) was an independent risk factor for pre-eclampsia (PE) (aOR [95% CI]: 5.350 [1.044-27.423], p = 0.044). Urinary Zn levels above the P50 decreased the risk of small for gestational age (SGA) birth head circumference (aOR [95% CI]: 0.315 [0.113-0.883], p = 0.028), but it increased the risk SGA length (aOR [95% CI]: 2.531 [1.057-6.062], p = 0.037). This study may provide valuable information for public health policies related to prenatal nutrition, while informing future efforts to de-fine urinary reference intervals for ETEs in pregnant women.
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Subsyndromal delirium (SSD) in the Intensive Care Unit (ICU) is associated with an increased morbidity with unknown post-discharge functional and cognitive outcomes. We performed a prospective multicenter study to analyze the mental status of patients during their first 72 h after ICU admission and its trajectory, with follow-ups at 3 and 6 months after hospital discharge. Amongst the 106 included patients, SSD occurred in 24.5% (n = 26) and was associated with the duration of mechanical ventilation (p = 0.003) and the length of the ICU stay (p = 0.002). After the initial 72 h, most of the SSD patients (30.8%) improved and no longer had SSD; 19.2% continued to experience SSD and one patient (3.8%) progressed to delirium. The post-hospital discharge survival rate for the SSD patients was 100% at 3 months and 87.5% at 6 months. At admission, 96.2% of the SSD patients were fully independent in daily living activities, 66.7% at 3-month follow-up, and 100% at 6-month follow-up. Most SSD patients demonstrated a cognitive decline from admission to 3-month follow-up and improved at 6 months (IQCODE-SF: admission 3.13, p < 0.001; 3 months 3.41, p = 0.019; 6 months 3.19, p = 0.194). We concluded that early SSD is associated with worse outcomes, mainly a transitory cognitive decline after hospital discharge at 3 months, with an improvement at 6 months. This highlights the need to prevent and identify this condition during ICU stays.
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Background: The family members of intensive care unit (ICU) patients play a crucial role in modern ICUs. These individuals are predisposed to the development of post-intensive care syndrome in family members (PICS-F), a syndrome experienced by family members of ICU patients in response to critical illness and characterised by new or worsening psychological symptoms. This study sought to evaluate the levels of anxiety and depression exhibited by the family members of patients hospitalised in the ICU. It also aimed to identify the risk factors associated with the experience of PICS-F, which should assist with its prevention in the future. Methods: The study sample comprised 164 ICU patients and their family members. Sociodemographic data were gathered at the time of ICU admission and 3 months after discharge, and the family members were screened for emotional distress using the Hospital Anxiety and Depression Scale (HADS). Comparison tests were used to test for an association between family/patient characteristics and a positive HADS score. In addition, a multivariable logistic regression model was constructed to identify the independent factors associated with a positive HADS score. Results: Emotional distress was identified in 24% of the family members 3 months after their relatives had been discharged from the ICU. A number of personal traits were found to be associated with emotional distress in the family members, namely unemployment (p = .008), smoking/drinking habits (p = .036) and personal history of psychopathology (p = .045). In the multiple logistic regression analyses, only unemployment was found to be an independent factor associated with both anxiety and depression in the family members (OR = 2.74, CI 95%: 1.09-6.93). No association was found between the patients' characteristics and emotional distress in the family members. Conclusions: The findings of this study indicate an association between emotional distress in the family members of ICU patients and their personal traits, thereby building on the prior literature by suggesting that patient characteristics are less pertinent to the experience of PICS-F. Unemployment may represent a meaningful risk factor for emotional distress in family members (a potential marker of PICS-F), given its relationship with family members' positive HADS scores post-ICU discharge. These findings should influence preventative strategies concerning PICS-F by illustrating the need to assess family characteristics and demographics early in a patient's ICU stay and, consequently, allowing for the early identification of at-risk individuals and the prompt implementation of adequate support services.
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OBJECTIVE: To evaluate the association between different intensive care units and levels of brain monitoring with outcomes in acute brain injury. METHODS: Patients with traumatic brain injury and subarachnoid hemorrhage admitted to intensive care units were included. Neurocritical care unit management was compared to general intensive care unit management. Patients managed with multimodal brain monitoring and optimal cerebral perfusion pressure were compared with general management patients. A good outcome was defined as a Glasgow outcome scale score of 4 or 5. RESULTS: Among 389 patients, 237 were admitted to the neurocritical care unit, and 152 were admitted to the general intensive care unit. Neurocritical care unit management patients had a lower risk of poor outcome (OR = 0.228). A subgroup of 69 patients with multimodal brain monitoring (G1) was compared with the remaining patients (G2). In the G1 and G2 groups, 59% versus 23% of patients, respectively, had a good outcome at intensive care unit discharge; 64% versus 31% had a good outcome at 28 days; 76% versus 50% had a good outcome at 3 months (p < 0.001); and 77% versus 58% had a good outcome at 6 months (p = 0.005). When outcomes were adjusted by SAPS II severity score, using good outcome as the dependent variable, the results were as follows: for G1 compared to G2, the OR was 4.607 at intensive care unit discharge (p < 0.001), 4.22 at 28 days (p = 0.001), 3.250 at 3 months (p = 0.001) and 2.529 at 6 months (p = 0.006). Patients with optimal cerebral perfusion pressure management (n = 127) had a better outcome at all points of evaluation. Mortality for those patients was significantly lower at 28 days (p = 0.001), 3 months (p < 0.001) and 6 months (p = 0.001). CONCLUSION: Multimodal brain monitoring with autoregulation and neurocritical care unit management were associated with better outcomes and should be considered after severe acute brain injury.
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Lesiones Traumáticas del Encéfalo , Lesiones Encefálicas , Humanos , Lesiones Encefálicas/terapia , Encéfalo , Lesiones Traumáticas del Encéfalo/diagnóstico , Unidades de Cuidados Intensivos , Escala de Consecuencias de GlasgowRESUMEN
BACKGROUND: Timely stratification of Crohn's disease (CD) is essential for patients' management. The use of noninvasive accurate biomarkers is key to monitor treatment and to pursue mucosal healing, the ultimate treatment endpoint in CD. OBJECTIVE: We aimed to evaluate the performance of readily available biomarkers and develop risk matrices to predict CD progression. METHODS: Data from 289 CD patients receiving infliximab (IFX) maintenance therapy for 2 years was collected; those patients were included in DIRECT, a prospective multicenter observational study. Disease progression was evaluated using two composite outcomes incorporating clinical and drug-related factors, the first including IFX dose and/or frequency adjustments. Univariate and multivariable logistic regressions were used to calculate the odds ratios (OR) and to develop risk matrices. RESULTS: The isolated presence of anemia at least once during follow-up was a significant predictor of disease progression (OR 2.436 and 3.396 [p ≤ 0.001] for composite outcomes 1 and 2, respectively) regardless of confounding factors. Isolated highly elevated C-reactive protein (CRP; >10.0 mg/L) and fecal calprotectin (FC; >500.0 µg/g) in at least one visit were also significant predictors, while milder elevations (3.1-10.0 mg/L and 250.1-500.0 µg/g) were only relevant when detected in at least two visits (consecutive or not). The combination of biomarkers in risk matrices had good ability to predict progression; patients simultaneously presenting anemia, highly elevated CRP and FC at least once had 42%-63% probability of achieving the composite outcomes. CONCLUSION: The combined evaluation of hemoglobin, CRP, and FC in at least one time point and their incorporation into risk matrices seems to be the optimal strategy for CD management, as data from additional visits did not meaningfully influence the predictions and may delay decision-making.
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Enfermedad de Crohn , Humanos , Infliximab/uso terapéutico , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/metabolismo , Estudios Prospectivos , Biomarcadores , Pronóstico , Progresión de la EnfermedadRESUMEN
BACKGROUND: Currently, the measurement of glomerular filtration rate is very complex and costly, so its daily evaluation is performed using endogenous markers, of which creatinine is the most frequently used. It allows the estimation of glomerular filtration rate by means of its clearance or by formulas based on its serum and urine concentration. Augmented renal clearance (ARC) is frequent among critically ill patients and is defined as creatinine clearance (CrCl) > 130 ml/min/1.73 m2. The aim of this study was to compare measured CrCl (MCC) and estimated CrCl obtained with the Cockcroft-Gault formula (CG), the Modification of Diet in Renal Disease Study equation (MDRD), and the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) in patients with severe traumatic brain injury and nontraumatic subarachnoid hemorrhage. The second aim was to assess the incidence of ARC in this population of neurocritical patients. METHODS: This was a prospective, observational, single center study from a cohort of 74 patients admitted to the neurocritical intensive care unit due to traumatic brain injury or subarachnoid hemorrhage. Serum creatinine (at 7 a.m.) and a 6-h urine collection were analyzed, and CrCl was measured and estimated by using CG, MDRD, and CKD-EPI. The intraclass correlation coefficient (ICC) was evaluated for each pair, and Bland-Altman plots were used to assess clinical significance. RESULTS: Among 74 patients, the median age was 53 (interquartile range [IQR] 36-65), and the median Glasgow Coma Scale score at admission was 6. The median MCC at admission was 176 (IQR 135-214). The medians of CG, MDRD and CKD-EPI were, respectively, 129 ml/min/1.73 m2 (IQR 95-176), 158 (IQR 115-202), and 116 (97-132). An ICC was applied to evaluate the correlation between MCC and estimated methods and showed a weak correlation between MCC and estimated CrCl obtained with the three different methods. The strongest ICC statistical correlation was found between MCC and MDRD, and the weakest correlation was found between MCC and CKD-EPI. Bland-Altman plots showed that differences between each pair were not clinically acceptable. ARC was present in 78% of measurements, using MCC. A weak correlation was observed between MCC and calculated CrCl. CG, MDRD, and CKD-EPI overestimated MCC when MCC ≤ 130 ml/min/1.73 m2 and underestimated it when MCC > 130 ml/min/1.73 m2. CONCLUSIONS: In this population, there was a weak statistical correlation between measured and estimated methods. In patients with ARC, formulas underestimated MCC. MCC should probably be the preferred methodology for renal function assessment in the clinical setting to better adjust drug dosage and guarantee drug effectiveness.