Multicenter Prospective Observational Study Research Articles

Frequent detection of anti-nuclear antibodies and low-titer rheumatoid factor in female patients with undifferentiated peripheral spondyloarthritis in Japan: a prospective observational study.

Studies on the clinical features of undifferentiated peripheral spondyloarthritis (upSpA) are limited. This study explores sex-based manifestations of upSpA and compares upSpA with rheumatoid arthritis (RA) under conditions of low human leukocyte antigen B27 positivity in Japan. In this multicenter prospective observational study, physical and laboratory findings from 29 upSpA cases (19 females, 10 males) were collected to investigate sex differences. Fourteen patients with RA were also enrolled as a control group to evaluate clinical parameters distinguishing upSpA and RA. Tenderness at the humeral epicondyles and the Achilles tendon were more common in female patients with upSpA than in males. Serum C-reactive protein (CRP) levels were lower in female patients with upSpA than in male patients. Serum rheumatoid factor (RF) levels were lower in upSpA cases than in RA, with a cut-off value of 84 IU/mL differentiating RA from upSpA. An anti-nuclear antibodies (ANA) test at a dilution of ≥1:160 was detected in about half of the female upSpA cases but not in male cases. Among upSpA and RA cases, female patients with upSpA frequently present with multiple enthesitis, low serum CRP levels, low-titer RF positivity, and a high incidence of ANA positivity.

Phenotypic Trajectories From Acute to Stable Phase in Heart Failure With Preserved Ejection Fraction: Insights From the PURSUIT-HFpEF Study.

Using machine learning for the phenotyping of patients with heart failure with preserved ejection fraction (HFpEF) has emerged as a novel approach to understanding the pathophysiology and stratifying the patients. Our objective is to perform phenotyping of patients with HFpEF in stable phase and to investigate the phenotypic trajectory from acute worsening phase to stable phase. The present study is a post hoc analysis of the PURSUIT-HFpEF (Prospective Multicenter Observational Study of Patients with Heart Failure with Preserved Ejection Fraction) study. We applied the latent class analysis to the discharge data of patients hospitalized for acute decompensated heart failure. We finally included patient data of 1100 cases and 63 features in the latent class analysis. All patients were subclassified into 5 phenogroups as follows: Phenotype 1, characterized by better renal function and lower NT-proBNP (N-terminal pro-B-type natriuretic peptide) level [N=325 (29.5%)]; Phenotype 2, higher blood pressure, sinus rhythm, and poor renal function. [N=242 (22.0%)]; Phenotype 3, higher prevalence of atrial fibrillation, higher tricuspid pressure gradient, and lower tricuspid annular plane systolic excursion [N=214 (19.5%)]; Phenotype 4, higher C-reactive protein level and higher tricuspid pressure gradient [N=245 (22.3%)]; and Phenotype 5, poor nutritional status, poor renal function, and higher NT-proBNP level [N=74 (6.7%)]. A particular phenotype observed at the time of discharge was correlated with a distinct phenotype of acute worsening. We identified 5 distinct stable phase phenotypes of the patients with HFpEF from the data at discharge. A specific phenotype at discharge was associated with a particular phenotype of acute worsening. This grouping can be a basis for future precision medicine of patients with HFpEF. URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000021831.

Overall impact of tethering and of its symmetric and asymmetric subtypes on early and long-term outcome of transcatheter edge-to-edge repair of significant mitral valve regurgitation.

Tethering is a common condition of the mitral valve apparatus in the presence of significant regurgitation. Its impact on outcomes of transcatheter edge-to-edge repair (TEER) remains poorly characterized. We appraised the prevalence, features, procedural details, and outcomes of patients with or without mitral valve tethering in a prospective multicenter observational study. The primary endpoint was the risk of cardiac death or rehospitalization for heart failure at mid-term follow-up. We included 2238 patients, 1467 (65.5%) without tethering and 771 (34.5%) with tethering (487 [21.8%] with symmetric and 284 [12.7%] with asymmetric tethering). Several differences in baseline features were evident among groups, yet procedural results were similar. After a median of 14months, rates of cardiac death or rehospitalization for heart failure was significantly higher at unadjusted analysis in patients with tethering (191 [24.8%] vs. 272 [18.5%] in those without tethering, p=0.001), but weres similar between tethering subtypes (p=0.666). At adjusted analysis, the presence of any tethering was no longer a significant predictor of cardiac death or rehospitalization for heart failure, and the same results were obtained focusing on tethering subtypes (all p>0.05). Tethering is common among patients with an indication to TEER, and is associated with adverse baseline and procedural features. In spite of this, device and procedural success rates are not significantly impacted by the presence of tethering that does not even have a negative prognostic effect at follow-up. Accordingly, tethering should not be considered a contraindication to TEER in suitable patients.

Characteristics of emergency department patients with confirmed diagnoses of chronic obstructive pulmonary disease vs patients with respiratory symptoms and a suspected diagnosis.

To describe differences in patient characteristics and case management between patients attended in emergency departments (EDs) with confirmed diagnoses of chronic obstructive pulmonary disease (COPD) vs those with respiratory symptoms in whom COPD is suspected. Prospective multicenter observational study of patients registered in a multipurpose database between November 14, 2022, and May 14, 2023, in 14 emergency departments in the public hospital system of Castile-Leon. We included patients aged 40 years or older with confirmed COPD or suspected COPD. Variables analyzed were patient characteristics, clinical presentation, and management of the emergency episode. Of a total of 1179 patients, 931 (78.9%) had diagnosed COPD and 248 (21.1%) had suspected COPD. The median (interquartile range) age was 76 years (68-83 years) and 305 (25.87%) were women. Variables related to suspected COPD were age between 40 and 65 years (odds ratio [OR], 0.46; 95% CI, 0.26-0.65) and female sex (OR,0.57; 95% CI, 0.42-0.77). Patients with diagnosed COPD had higher Charlson comorbidity scores (OR, 1.93; 95% CI,1.42-2.63), and more of them were using inhalers (OR, 3.43; 95% CI, 2.57-4.61). Admission to a respiratory care ward (OR, 1.39; 95% CI, 1.97-3.01) and need for noninvasive mechanical ventilation (OR, 3.21; 95% CI, 1.27-10.71) were more common in patients with diagnosed COPD. However, no differences were observed in the frequency of hospitalization overall or 30-day mortality. Clinical characteristics and management of emergency care differ between patients with confirmed vs suspected COPD. Patients with suspected COPD had more limited access to certain diagnostic, therapeutic, and follow-up resources.

WCN25-4521 A Multicentre Prospective Observational Study of Ambulatory Blood Pressure Monitoring in Indian Patients With and Without Chronic Kidney Disease

WCN25-4521 A Multicentre Prospective Observational Study of Ambulatory Blood Pressure Monitoring in Indian Patients With and Without Chronic Kidney Disease

Neurodevelopmental outcomes of permanent and temporary CSF diversion in posthemorrhagic hydrocephalus: a Hydrocephalus Clinical Research Network study.

This study investigated neurodevelopmental outcomes in preterm neonates with posthemorrhagic hydrocephalus (PHH), focusing on the comparative effectiveness of temporary and permanent CSF diversion strategies. This multicenter prospective observational cohort study (2012-2021) involved preterm infants diagnosed with PHH who underwent either initial permanent or temporary CSF diversion. Patients were assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III), at 15-30 months and, when possible, at 36-42 months of corrected age. Statistical analyses included univariable and multivariable regression models to examine the associations between BSID-III scores and various treatment and patient factors. Among 106 patients, 15 (14%) underwent initial permanent CSF diversion, while 91 (86%) received temporary diversion. Patients who underwent permanent diversion had lower cognitive scores (58.2 ± 5.7) compared to those temporized (69.0 ± 15.9) (p = 0.01). Temporized patients who later required conversion to permanent diversion demonstrated poorer composite (66.6 ± 18.0 vs 79.9 ± 18.8, p = 0.02), expressive (4.6 ± 3.2 vs 7.0 ± 3.7, p = 0.03), and receptive (4.2 ± 3.3 vs 6.1 ± 3.0, p = 0.04) language scores compared to those weaned from temporary CSF diversion. No significant difference in outcomes was observed between patients temporized with a ventriculosubgaleal shunt versus a ventricular reservoir. Ventricle size at the time of initial CSF diversion was not associated with BSID-III scores. However, univariable analysis showed that a larger ventricle size at the time of conversion to permanent diversion was associated with lower neurodevelopmental scores across all domains. Multivariate analysis, adjusting for intraventricular hemorrhage (IVH) grade, complex chronic conditions, and postmenstrual age, revealed that larger ventricle size at the time of conversion correlated negatively with composite motor (effect size -0.47, CI -0.82 to -0.11, p = 0.01) and fine motor (-0.08, CI -0.15 to -0.01, p = 0.03) scores. This study suggested that the choice between permanent and temporary CSF diversion as initial treatments may affect neurodevelopmental outcomes in preterm neonates with PHH, which are influenced by IVH severity and timing of intervention. The findings support early temporization and avoiding delays to optimize permanent shunting. Monitoring ventricular size closely during this phase is critical, as larger ventricular size at the time of conversion is associated with poorer outcomes. These results highlight the necessity for adapting treatment strategies on the basis of individual patient characteristics, responses, and progress in managing PHH.

SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision.

Accumulated data suggest that routine use of defunctioning stoma in low anterior resection for rectal cancer may cause kidney injury, bowel dysfunction and a higher risk of permanent stomas. We aim to study whether avoidance of a diverting stoma in selected patients is safe and reduces adverse consequences. SELSA is a multicentre international prospective observational study nesting an open-label randomized clinical trial. All patients with primary rectal cancer planned for low anterior resection are eligible. Patients operated with curative intent, aged <80 years, with an American Society of Anaesthesiologists' fitness grade I or II, and a low predicted risk of anastomotic leakage are eligible to 1:1 randomization between no defunctioning stoma (experimental arm) or a defunctioning stoma (control arm). The primary outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS score, and permanent stoma rate. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients. Patient inclusion will commence in the autumn of 2024. The SELSA study is investigating a tailored approach to defunctioning stoma use in low anterior resection for rectal cancer in relation to the risk of anastomotic leakage. Our hypothesis is that long-term effects will favour the selective approach, enabling some patients to avoid a defunctioning stoma. Swedish Ethical Review Authority approval (2023-04347-01, 2024-02418-02 and 2024-03622-02), Regional Ethics Committee Denmark (H-24014463), and ClinicalTrials.gov (NCT06214988).

Effects of SGLT2i on right ventricule function in HFpEF: an echocardiographic study

Abstract Background several studies have demonstrated the cardioprotective effects of Sodium-glucose co-transporter 2 inhibitors (SGLT-2i) in patients with heart failure (HF), irrespective of the presence of diabetes. These findings have culminated in new recommendations for SGLT2i in the treatment of HF, either with reduced or preserved ejection fraction (EF). Purpose the purpose of this study was to analyze the effect of Gliflozin on right ventricular function, in patients with HFpEF, using speckle tracking echocardiography and new echocardiographic surrogates of right ventricular-pulmonary artery (RV-PA) coupling. Methods we enrolled 105 symptomatic HF patients (aged 71,143 ± 9,913 years) with EF &amp;gt; 40% (47,9 ± 7,26) into a multicentric prospective observational study; main anamnestic information, NT-proBNP values and complete echocardiographic data were collected in an ambulatory setting, at time of enrolment and after 6 months of therapy with SGLT-2i. The echocardiographic analysis included conventional, tissue-derived imaging, and myocardial deformation speckle tracking echocardiography of left and right sections. TAPSE/PASP (tricuspid annular plane systolic excursion/pulmonary artery systolic pressure) and RVFWLS/PASP (Right ventricle free wall longitudinal strain) were also collected as surrogates of RV-PA coupling such as Results after 6 months of SGLT-2i therapy echocardiographic evaluation revealed improvement of LVEF (47,909 ± 7,260; 49,562 ± 8,784; p value 0.003) LVGLS (-13,312 ± 3,555; -14,894 ± 3,970; p value &amp;lt; 0.001), RVFWLS (-18,324 ± 6,430; -20,705 ± 6,469; p value 0.002). Echocardiographic parameters of diastolic function such as E/E’m (11,270 ± 6,282; 9,782 ± 6,622; p value 0.003) and PASP (36,580 ± 14,879; 31,757 ± 10,740; p value 0.036) were also ameliorated. Both TAPSE/PASP (0,567 ± 0,267; 0,762±0,536; p value 0.036) and RV FWLS/PASP (-0,588 ± 0,299; -0,785 ± 0,663 p value 0.003) showed higher values. Conclusions our study has demonstrated a significant impact of SGLT-2i on echocardiographic parameters of LV diastolic function and on both left and right ventricle systolic function in patients with HFpEF in a 6 months follow up. Moreover, our findings of RV-PA coupling echocardiographic surrogates improvement, after SGLT-2I use, could underscore the potential of SGLT-2i in managing RV dysfunction in HFpEF.

Prognostic utility of non-invasive left atrial stiffness index in patients with heart failure with preserved ejection fraction: insights from EASY-HFpEF study

Abstract Background It is known that an increase left atrial stiffness is associated with poor prognosis in patients with heart failure with preserved ejection fraction (HFpEF). Purpose We evaluated the predictive utility of non-invasive left atrial stiffness index (LASI) in HFpEF patients, comparing it to other clinical prognostic indicators. Methods Patients were recruited from the EASY-HFpEF study, a multicenter prospective observational cohort study in Japan involving patients hospitalized with acute decompensated heart failure and a left ventricular ejection fraction of &amp;gt;40%. Among the patients in the study, those with registered echocardiographic image data of sufficient quality were analyzed for left atrial strain. The LASI was calculated as the ratio of E/e’ to the left atrial reservoir strain. The primary endpoint was a composite outcome of all-cause death and readmission due to heart failure during the 2-year follow-up period. Results We analyzed 95 patients, with a median age of 75 years and including 41% female patients. LASI was associated with an increased risk of composite outcome (adjusted HR 1.10 [95%CI; 1.04-1.17, P=0.001] per 0.1 increase). LASI was non-inferior in predictive ability compared to predictors such as B-type natriuretic peptide (BNP) and H2FPEF score. (AUCLASI=0.79, AUCBNP=0.80 [vs.AUCLASI, P=0.775], AUCH2FPEF =0.75 [vs.AUCLASI, P=0.342]) (Figure 1). The addition of LASI significantly improved the prognostic power of a model containing BNP and H2FPEF score (model of BNP+H2FPEF score, χ2=29.3; model of BNP+H2FPEF+LASI, χ2=40.5, P=0.004) (Figure 2). Conclusion Non-invasive LASI in HFpEF patients is associated with increased risks of all-cause mortality and heart failure readmission, its potential utility in predicting these adverse events.

P-1210. Resurgence of Parechovirus-A3 Infection in Neonates and Young Infants after the Coronavirus Disease 2019 Pandemic in Japan

Abstract Background Parechovirus-A (PeV-A), especially PeV-A3, is a common cause of viral sepsis and encephalitis in neonates and young infants (age &amp;lt; 4 months). The strict infection control measures and non-pharmaceutical interventions of the coronavirus disease 2019 (COVID-19) pandemic affected the epidemiological profiles of community-acquired diseases. However, the effects of the pandemic on the epidemiology of PeV-A infection in this age group are unknown. Methods This prospective multicenter observational study was conducted between 2019 and 2023 in 12 Japanese prefectures. Neonates and young infants hospitalized for suspected sepsis and/or meningoencephalitis were included. Samples were sent to the laboratory of Niigata University, and PeV-A was detected by real-time PCR. The 7 hospitals introduced the BioFire Filmarray meningitis/encephalitis (FA/ME) panel in 2020. Genotype was determined by direct sequencing and BLAST analysis, and the phylogenetic tree of viral protein 1 region of PeV-A3 was constructed. Results 131 patients with PeV-A infection were identified (n = 36 in 2019, n = 7 in 2020, n = 1 in 2021, n = 27 in 2022, and n = 60 in 2023). Genotype was PeV-A3 in 124 cases and PeV-A4 in 2 cases in 2022 and unknown in 5 cases in 2019. Seasonal peaks and other characteristics were similar before and after the COVID-19 pandemic (i.e., in 2019 vs. 2023). Body temperature, fever duration, and the proportion of patients with rash declined; however, the proportion of those with abdominal distention increased. The FA/ME panel was more frequently used after the start of the pandemic (3.2% vs. 53.3%, P &amp;lt; 0.001). The proportion of those with sepsis declined from 83.9% to 63.3% (P = 0.04), but the proportions of those with encephalitis and those requiring ICU admission were similar. No patient had sequelae at discharge. PeV-A3 has evolved within a single clade with two branches. Conclusion The number of PeV-A3 infections was higher after the start of the COVID-19 pandemic, possibly because low PeV-A3 activity early in the pandemic increased the number of susceptible pregnant women, thus leading to a decline in maternally derived antibodies. In addition, use of the FA/ME panel might help detect mild cases. Disclosures All Authors: No reported disclosures

P-1236. Vancomycin Population Pharmacokinetics Using Volumetric Absorptive Microsampling in Critically Ill Children with Multiple Organ Dysfunction Syndrome

Abstract Background Vancomycin (VAN) is the most frequently used antibiotic for hospitalized patients in the United States. Wide use occurs as it is a first line treatment for severe gram-positive bacterial infections in both adults and pediatrics. Most VAN dosing in children with multiple organ dysfunction syndrome (MODS) is guided via population pharmacokinetic (PK) approaches based on creatinine clearance equations and frequent samplings. Volumetric absorptive microsampling (VAMS) offers sampling procedures that require as little as 20 mcL of blood. The primary objective of this study was to develop a population PK (popPK) model for VAN in children with MODS using VAMS.Table 1.Population parameter estimation values. Methods We conducted a multi-center prospective observational study of VAN PK in pediatric MODS. Subjects (&amp;lt; 18 years) participating in a larger observational study of children with MODS in the ICU were eligible. Up to 15 PK samples were collected over 3 consecutive days, along with pertinent covariate data. Parametric popPK modeling was performed using Monolix 2024R1. Covariate selection was based on improvements in objective function value and physiologic relevance. Children on CRRT were excluded from the present analyses. Subjects in our interim analysis were also excluded from analysis if they were missing demographic information or were pending data queries on VAN concentrations.Figure 1.Individual weighted residuals according to time and individual predictions. Results 52 subjects from 8 sites were included with a median age of 6.5 y (range: 2 m–17 y) and a median weight of 24.5 kg (range: 3-214). A two-compartment model with clearance adjusted for allometric scaling and estimated glomerular function best described the data. Population predictions were modest (R2=0.28) whereas individualized predictions were improved (R2=0.61). Between subject variation for clearance and volume of distribution was high even after correcting for U25 creatinine clearance (92.7% and 107.9%, CV% respectively).Figure 2.Observed vs. population (A) and individual (B) predictions for the model. Conclusion Children with MODS display high between subject variability of VAN clearance and volume of distribution. Frequent sampling is needed because “stead-state” does not exist in the early period of MODS for children. VAMS can facilitate small volume sampling and future Bayesian models based on data such as these can facilitate fewer sampling events to classify the patient’s dynamic clearance. Disclosures Nathaniel J. Rhodes, PharmD MS, Apothecademy, LLC: Advisor/Consultant Kevin J. Downes, MD, Paratek, Inc.: Grant/Research Support|Veloxis Pharmaceuticals, Inc.: Grant/Research Support Marc H. Scheetz, PharmD, MSc, Abbvie: Advisor/Consultant|Basilea: Advisor/Consultant|Cidara: Advisor/Consultant|DoseMe: Advisor/Consultant|Entasis: Advisor/Consultant|F2G: Advisor/Consultant|GSK: Advisor/Consultant|Lykos: Advisor/Consultant|Roche: Advisor/Consultant|Third Pole Therapeutics: Advisor/Consultant|Xelia: Advisor/Consultant

Predictive factors of fibrotic interstitial lung abnormality on high-resolution computed tomography scans: a prospective observational study

BackgroundFibrotic types of interstitial lung abnormalities seen on high-resolution computed tomography scans, characterised by traction bronchiolectasis/bronchiectasis with or without honeycombing, are predictors of progression and poor prognostic factors of interstitial lung abnormalities. There are no reports on the clinical characteristics of fibrotic interstitial lung abnormalities on high-resolution computed tomography scans. Therefore, we aimed to examine these clinical characteristics and clarify the predictive factors of fibrotic interstitial lung abnormalities on high-resolution computed tomography scans.MethodsClinical and paraclinical data of 164 patients enrolled in the initial year of a multicentre prospective observational study (Kumamoto interstitial lung abnormalities study in Japan) involving over 62,000 examinees during routine health examinations were analysed. Clinical laboratory evaluations are expressed as medians and interquartile ranges for each evaluation time point, and boxplots were created for graphical representation. The percentages of abnormal clinical laboratory results were compared between the groups using chi-square or Fisher’s exact tests. Univariate or multivariate logistic regression analyses were performed to analyse the relationship between fibrotic interstitial lung abnormalities and other clinical factors.ResultsFibrotic interstitial lung abnormalities were observed on high-resolution computed tomography scans in 135 (82%) patients at the time of diagnosis. Multivariate analysis showed that older age (Odds ratio, 1.06; 95% confidence interval, 1.01–1.12; p = 0.021), auscultatory fine crackles (Odds ratio, 3.39; 95% confidence interval, 1.33–8.65; p < 0.01), and elevated serum surfactant protein-D (Odds ratio, 2.68; 95% confidence interval, 1.02–8.64; p = 0.045) were independent predictive factors of fibrotic interstitial lung abnormalities. The predicted area under the curve of the fibrotic interstitial lung abnormalities based on these three factors was 0.77 (95% confidence interval, 0.68–0.86). The proportion of undecided diagnoses in the fibrotic interstitial lung abnormalities group (14%) was significantly lower than that in the non-fibrotic interstitial lung abnormalities group (41%) (p = 0.0027).ConclusionsFine crackles on auscultation and elevated serum surfactant protein-D levels are predictors of fibrotic interstitial lung abnormalities in older patients with interstitial lung abnormalities. These findings may assist non-radiological physicians in referring patients to specialists for early intervention in progressive fibrotic interstitial lung diseases.Trial registration number/dateUMIN000045149/2021.12.1.

Predicting early diagnosis of intensive care unit-acquired weakness in septic patients using critical ultrasound and biological markers

ObjectiveEarly diagnosis of intensive care unit-acquired weakness (ICUAW) is crucial for improving the outcomes of critically ill patients. Hence, this study was designed to identify predisposing factors for ICUAW and establish a predictive model for the early diagnosis of ICUAW.MethodsThis prospective observational multicenter study included septic patients from the comprehensive ICUs of West China Hospital of Sichuan University and 10 other hospitals between September and November 2023. Inclusion criteria were as follows: age over 18 years; expected ICU stay longer than 3 days; and voluntary informed consent. Patients were classified into ICUAW (MRC score < 48) and non-ICUAW (MRC score ≥ 48) groups based on muscle strength assessments. The analyzed key predictive factors encompassed demographic data, SOFA and APACHE II scores, inflammatory markers (PCT, IL-6, and CRP), and ultrasound measurements of muscle thickness and cross-sectional area. Logistic regression analysis was conducted for variable selection and nomogram model construction.ResultsA total of 116 septic patients were included, comprising 77 males and 39 females (mean age: 56.94 ± 19.90 years). A nomogram model predicting ICUAW probability was developed, which involved vastus intermedius diameter, rectus femoris cross-sectional area, IL-6, and CRP. The AUC of the composite diagnostic ROC curve was 0.966 (95%CI: 0.936 − 0.996), with a sensitivity of 88% and a specificity of 95.8%.ConclusionsConclusively, a nomogram model is constructed for diagnosing ICUAW in septic patients, which is simple and rapid and allows for visual representation, with excellent diagnostic capability.

D-dimer cutoff values for predicting functional prognosis in patients with severe head trauma: a multi-centre prospective observational study.

D-dimer, a fibrinolysis indicator, may predict functional and life outcomes in traumatic brain injury (TBI) patients. We aimed to identify optimal D-dimer cutoff values for poor functional outcomes in severe TBI. We used data from a multi-centre prospective observational cohort study that included patients with TBI with a Glasgow Coma Scale (GCS) score ≤ 8 within 48h after injury or required neurosurgical procedures. We selected patients admitted ≤ 1h after injury. Neurological function at discharge was assessed using the modified Rankin Scale (mRS). The association between D-dimer levels at admission and neurological function (mRS ≥ 4 or < 4), adjusted for age, GCS, systolic blood pressure, and head abbreviated injury scale (AIS) score, was determined by logistic regression analysis. The predictive utility of D-dimer levels was assessed using the area under the receiver operating characteristic curve (AUC), with the cutoff value being determined using Youden's index. Among the 336 patients, most were male; approximately half had experienced motor vehicle accidents. The median (interquartile range) of age, GCS scores, and head AIS scores were 65 (40.25 - 78.75) years, 7 (4 - 9), and 5 (4 - 5), respectively. Overall, 214 (63.7%) patients had poor neurological function (mRS ≥ 4). D-dimer levels > 28µg/mL predicted poor functional prognosis (odds ratio = 3.84 [95% confidence interval 1.62 - 9.11]); the AUC and cutoff values were 0.73 and 27.2µg/mL, respectively. A cutoff value of 27.2µg/mL for early-stage D-dimer levels could predict the functional prognosis of patients with severe isolated TBI.

P0893 Angiopoietin-like Protein 8 (ANGPTL8) in Inflammatory Bowel Disease and Its Response to Anti-TNFα Therapy; A Prospective Multi Center Study

Abstract Background Crohn’s disease (CD) is a chronic condition characterized by persistent inflammation of the gastrointestinal tract. Tumour necrosis factor-alpha (TNFα), a key pro-inflammatory cytokine, plays a crucial role in the disease process. Anti-TNF therapies have significantly improved CD treatment by reducing inflammation. Emerging evidence show that Angiopoietin-like protein 8 (ANGPTL8) is a novel protein and may also be involved in regulating inflammation. This study aimed to investigate the changes in ANGPTL8 level in patients with IBD compared to healthy individuals and evaluates the impact of Anti-TNF therapies on this protein. Methods This is a prospective multi-center observational study. Patients were recruited from January 2022 to June 2024. Patients were divided into 3 groups; patients with CD in clinical remission receiving infliximab for at least 24 weeks (IFX-experienced group), healthy controls (control group), and patients with CD scheduled to start infliximab (IFX-naïve group). ANGPTL8 levels were measured 24 hours before next maintenance infliximab dose in IFX-experienced group, randomly in control group, and at week 0 and week 24 in IFX-naïve group. ANGPTL8 levels were measured using enzyme-linked immunosorbent assays (ELISA). A normality test was conducted for continuous variables, accordingly variables with normal distribution a parametric t-test was applied, otherwise Mann–Whitney U test was applied to compare between treated and untreated groups for skewed variables. Results A total of 166 patients were included in this study. The number of patients with CD and IFX-experienced and IFX-naive were 82 and 13, respectively. Seventy-one were healthy controls. Mean age ranged from 27 to 33 years of age across the three groups (table 1). Eighty-four (51%) were females. ANGPTL8 levels were significantly higher in patients with CD (138.26 ± 8.47 pmol) compared to the healthy control group (102.52 ± 5.99 pmol, p = 0.001). Among the 13 IFX-naive patients receiving anti-TNFα treatment, ANGPTL8 levels decreased significantly from 145.06 ± 17.93 pmol pre-treatment (week 0) to 81.78 ± 10.61 pmol post-treatment (week 24), p = 0.007. Conclusion Our findings suggest that ANGPTL8 is elevated in CD and may be involved in the inflammatory processes. The marked reduction in ANGPTL8 levels following anti-TNFα treatment indicates its potential as a biomarker for treatment response. Further research is needed to understand the exact mechanisms through which ANGPTL8 influences CD progression and its utility in clinical practice.

P1235 COlombian PrevaLence of Extraintestinal Manifestations in Inflammatory bowel disease in an adult and pediatric cohort after evaluation by a multidisciplinary group COLEMI – study

Abstract Background Inflammatory Bowel Disease (IBD) is increasingly recognized as a systemic disorder, given its high prevalence of extra-intestinal manifestations (EIM) affecting various organs. The frequency of these manifestations varies depending on factors such as geographical region, IBD subtype, disease location, disease duration, and the timeliness of diagnosis, yet data on this topic remain limited in Latin America. This study aimed to assess the prevalence of the primary EIMs in IBD patients in Colombia, as well as to examine differences between Crohn's disease (CD) and ulcerative colitis (UC). Methods Prospective observational descriptive multicenter study in adult and pediatric patients with IBD of the Colombian IBD Foundation, with suspicious of EIM and after confirmed with by a multidisciplinary group in Colombia. Results A total of 266 out of 482 (55.1%) patients with inflammatory bowel disease (IBD) were suspected of having extra-intestinal manifestations (EIM) by their gastroenterologists, of which 197 (74.1%) were confirmed upon evaluation by a multidisciplinary team, resulting in an EIM prevalence of 40.9%, with a predominance of female patients (67.5%). Of the cohort, 95% were adults and 5% were pediatric patients, with 134/197 (68%) diagnosed with ulcerative colitis (UC) and 63/197 (32%) with Crohn's disease (CD), 49.2% of whom required biologic therapy. In UC patients, extensive colitis (E3) was the most common disease extension, while ileo-colonic (L3) involvement predominated in CD. The most frequent types of EIM were articular (36%), followed by cutaneous (34.5%) and ocular (24.9%) manifestations. The hospitalization rate due to IBD was 72.5%, with EIM present in 37.5% of UC patients and 52.5% of CD patients (Figure 1). Hepatobiliary manifestations (odds ratio [OR] = 1.931; 95% confidence interval [CI] 0.4311-13.66, p=0.44) were more common in UC compared to CD, whereas articular (OR=2.277; 95% CI 1.228-4.22), cutaneous (OR=1.027; 95% CI 0.5474-1.925), oral (OR=2.017; 95% CI 0.8727-4.661), and ocular (OR=2.683; 95% CI 1.374-5.23) manifestations were more frequent in CD (Figure 1). In terms of the number of EIMs, 71.5% of UC patients had one, 16% had two, and 12.5% had three or more, while in CD, 50.7% had one, 27% had two, and 22.2% had three or more. A higher prevalence of EIM was observed in the central region of the country (Figure 2). Conclusion The prevalence of EIM in this Colombian cohort was high (40,9%), predominating the CD, female, extensive disease and higher requirement for biologicals.

Association between nutritional status, daily nutrition delivery and clinical outcomes of critically ill adult patients admitted to the intensive care unit: a protocol for Isfahan multicentre prospective observational cohort ICU study (the Isfahan-ICU study)

IntroductionThere is currently limited information regarding the association between the modified Nutrition Risk in Critically Ill (mNUTRIC) score, nutrition delivery and clinical outcomes in critically ill patients admitted to the...

P0592 Safety of the Adjuvant Recombinant Herpes Zoster Vaccine in Crohn’s Disease and Ulcerative Colitis: A Real-World Study

Abstract Background The incidence of inflammatory bowel disease (IBD) is increasing, and herpes zoster (HZ) occurrence in IBD patients, particularly those on immunosuppressive drugs, is a growing concern. The herpes zoster adjuvant recombinant vaccine (Shingrix) may provide a safer alternative to live vaccines, but real-world data on its safety in IBD patients is limited. Methods This multicenter prospective observational study is being conducted from August 2023 to July 2025. Patients diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) who receive the herpes zoster subunit vaccine will be followed for 30 days post-vaccination to assess adverse events (AE) and vaccine safety. Results A total of 244 patients were enrolled in the study, consisting of 141 with ulcerative colitis (UC) and 103 with Crohn’s disease (CD). The mean age of the cohort was 45.3 years, with UC patients being older on average (49.7 years) than CD patients (39.3 years, p&amp;lt;0.01). After the first dose, injection site pain was the most commonly reported local adverse event, occurring in 51.2% of patients (UC: 49.6%, CD: 53.4%; p=0.56). Other local adverse events, such as redness (2.0%) and swelling (1.2%), showed no significant differences between UC and CD groups (p&amp;gt;0.05). Systemic adverse events following the first dose included fatigue (19.3%), myalgia (34.0%), headache (16.0%), shivering (11.5%), fever (11.5%), and gastrointestinal symptoms (6.6%). There were no significant differences between UC and CD patients for these events (p&amp;gt;0.05). Rare severe adverse events were noted, including one case of a disease flare requiring hospitalization in a CD patient post-vaccination (0.4%). Additional events classified as 'others' included itching, Bell’s palsy, and dizziness, with no significant group differences. For the second dose, 132 patients (UC: 78, CD: 54) were followed. Local adverse events included injection site pain reported by 53.8% of patients (UC: 48.7%, CD: 61.1%; p=0.16). Systemic adverse events, such as fatigue (25.8%), myalgia (35.6%), and headache (15.9%), were similarly reported without significant differences between UC and CD groups (p&amp;gt;0.05). Severe adverse events were not observed after the second dose. Other non-severe adverse events reported included sore throat, nausea, and rash, with no group-specific statistical significance. Conclusion The herpes zoster adjuvant recombinant vaccine appears to be safe for use in IBD patients, with no significant differences in adverse events between UC and CD groups. This study suggests that the adjuvant vaccine is a viable alternative to live attenuated vaccines, especially in patients receiving immunosuppressive therapy. Further studies are warranted to confirm its long-term safety and efficacy in this population.

P0741 Adherence to mesalazine suppositories maintenance treatment in patients with ulcerative proctitis: MESUPO multicenter prospective observational study from GETECCU

Abstract Background Mesalazine suppositories are recommended in guidelines for the induction and maintenance of remission in patients with ulcerative proctitis (UP). Nevertheless, nonadherence can be frequent and the recommended dose of mesalazine suppositories in maintenance treatment remains unknown. The aim of this study was to determine the frequency of non-adherence to mesalazine suppositories, evaluate potential factors for nonadherence and the impact on quality of life and number of relapses in patients with UP. Methods A multicenter, prospective observational study was designed in patients ≥18 years old with UP under maintenance treatment with mesalazine suppositories (Claversal© 500 mg, Pentasa© 1g or Salofalk©1g). We evaluated adherence, sociodemographic data and complications associated with poor adherence at 6 and 12 months. Adherence was assessed by tracking pharmacy refills (medication possession ratio, MPR). We defined good adherence as MPR ≥80% over 12 months. Health-Related Quality of Life (HRQoL) was evaluated using the disease-specific shortened Spanish version of the IBDQ (SIBDQ-9). Relapse was defined as partial Mayo ≥2. Quantitative data were analyzed using Rstudio software (version 2023.12.1 + 402) Results A total of 188 patients with mean age 51 were consecutively included across 14 Spanish hospitals (Table 1). Of these, mean MPR was 76% and 56% presented MPR ≥80%. Mean age was higher among patients with MPR ≥80% (p=0.045). A total of 31 patients (16%) had a relapse and 3 (1.6%) patients were hospitalized during the follow-up. Unemployment(OR=5.08, p=0.025), concomitant anal pathology (OR=5.08, p =0.025) and use of corticosteroids during the follow-up (OR=4.25, p=0.041) were associated with better adherence. There were no differences between the different brands and doses of suppositories analyzed. Low adherence was not related with increased number of flares (p=0.927), hospitalizations (p=0.225) or decreased quality of life (p = 0.353) over the 12 months of follow-up. Conclusion Almost half of patients with UP on maintenance treatment with mesalazine suppositories have low adherence. Older age, unemployment, use of corticosteroids during the follow-up or the presence of concomitant anal pathology may increase adherence, but poor adherence to mesalazine suppositories was not related with risk of relapse, hospitalizations or worst quality of life.

Andexanet alfa in patients with factor Xa inhibitor associated intracranial hemorrhage: the prospective observational multicenter ASTRO-DE study.

Hematoma expansion after intracranial hemorrhage (ICH) in anticoagulated patients signifi-cantly influences clinical outcomes and mortality, emphasizing the need for effective reversal agents. Andexanet alfa is a specific reversal agent for factor Xa associated major bleeding. The ASTRO-DE study collected real-world evidence on the effect of andexanet alfa on mitigat-ing hematoma expansion and altering prognosis in rivaroxaban- or apixaban-treated patients with ICH. ASTRO-DE was a prospective non-interventional cohort study conducted at 25 certified stroke centers in Germany. The primary outcome was the hematoma volume change and the propor-tion of patients with hematoma growth ≤33% within 12-72 h or until first control imaging. Sec-ondary endpoints included in-hospital thromboembolic events and mortality up to 90 days. A total of 137 patients (47.4% male, mean age 80.0 years) with ICH (92.6% spontaneous, 87.4% intracerebral), mean NIHSS on admission of 11.2 points, and mean initial hematoma volume of 26.5 mL (median: 14.1 mL) were analyzed. Ninety patients (65.7%) suffered ICH while treated with apixaban and 47 (34.3%) with rivaroxaban. The median time between symptom onset and application of andexanet alfa was 3.3 h, door-to-needle time was 1.3 h. The mean change in hematoma volume until the first control imaging, conducted after a median of 15.6 h, was 2.3 mL (95% CI: 0.4 to 4.2), while the change within 12-72 h was 1.8 mL (95% CI: 0.4 to 3.2). Hema-toma growth ≤33% was achieved in 90.3% of the 93 evaluable patients based on first control imaging and in 90.5% of the 63 evaluable patients, considering only imaging performed within the 12-72 h window. During hospitalization, death occurred in 30/137 patients (21.9%) and 17 thromboembolic events in 11/137 (8.0%) patients. The 90-day-mortality was 47/128 (36.7%). ASTRO-DE is the first prospective observational study systematically collecting standardized clinical routine data with andexanet alfa treatment. The study demonstrated favorable hemo-stasis and minimal mean hematoma volume growth in patients with ICH associated with apixa-ban or rivaroxaban treatment.