Carla Pérez-Ingidua

Aim: To analyse the clinical, technical, and demographic factors associated with tunnelled central venous catheter dysfunction in patients undergoing haemodialysis. Design: Multicentre, retrospective session‐level observational study. Methods: We analysed 40,193 haemodialysis sessions from 743 patients with tunnelled central venous catheters. Descriptive and univariate analyses were performed to explore associations between catheter dysfunction and clinical, technical and treatment‐related variables. Dysfunction within a session was defined by a blood flow < 300 mL/min together with abnormal arterial (< −250 mmHg) or venous (> +250 mmHg) pressures at baseline or 60 min. Data Source: Nefrosoft clinical system (January–December 2021). Results: As expected from the operational definition, sessions classified as dysfunctional showed lower blood flow and more extreme arterial and venous pressures. Beyond the intradialytic markers included in the operational definition, dysfunctional sessions more frequently involved management‐related measures such as catheter line reversal and the use of 5% heparin locks, as well as catheter placement in the left internal jugular vein and comorbidities such as diabetes and cardiovascular disease. Because line reversal and 5% heparin locks may represent responses to poor catheter performance, these findings should be interpreted cautiously. Sessions with dysfunction also showed lower dialysis efficacy, particularly in male patients. Overall systemic anticoagulant therapy was more frequent in sessions with dysfunction, whereas overall systemic antiplatelet therapy, analysed as a binary variable, was not significantly associated with the event. Conclusion: Catheter dysfunction is a frequent complication with multifactorial associations. Our findings highlight the importance of systematic clinical and technical monitoring during haemodialysis sessions. Associations identified here are descriptive and hypothesis‐generating; further studies with adjusted analyses are needed before conclusions about prediction or causality can be drawn.

Background: COVID-19 vaccination has demonstrated a favorable safety profile in children; however, factors associated with the occurrence of adverse events (AEs) following immunization remain insufficiently characterized. This study aimed to identify the demographic and clinical factors associated with AEs following COVID-19 vaccination in children aged 5–11 years. Methods: We conducted an ambispective observational cohort study in Madrid, Spain, including children aged 5–11 years vaccinated with the 10 µg formulation of BNT162b2 (Comirnaty^®, Pfizer-BioNTech). Data were obtained from vaccination registries, electronic health records, and structured telephone interviews with parents or legal guardians. Demographic characteristics, anthropometric variables, previous SARS-CoV-2 infection, medical history, and concomitant medication use were evaluated. Univariable analyses and multivariable logistic regression were performed to identify factors independently associated with the occurrence of suspected AEs. Results: A total of 2026 children were included. Suspected AEs were reported in 759 participants (37.5%). In univariable analyses, greater weight, height, pre-existing medical conditions, concomitant medication use, clinically vulnerable status, and previous SARS-CoV-2 infection were significantly associated with AEs. In the multivariable model, previous SARS-CoV-2 infection (OR 4.07, 95% CI 3.13–5.30), number of concomitant medications (OR 7.77, 95% CI 5.22–11.56), number of pre-existing medical conditions (OR 1.86, 95% CI 1.62–2.14), and height (OR 1.03, 95% CI 1.01–1.04) remained independently associated with AEs. Age, sex, body mass index, and clinically vulnerable status were not independently associated with AE occurrence. Conclusions: In this large real-world pediatric cohort, previous SARS-CoV-2 infection, comorbidity burden, and concomitant medication use were independently associated with adverse events following COVID-19 vaccination. These findings suggest that underlying clinical complexity may be a more important determinant of post-vaccination reactogenicity than demographic characteristics and support the value of individualized pre-vaccination assessment in pediatric populations.

Background: Tunneled central venous catheter dysfunction is a frequent and clinically relevant complication in hemodialysis, with a direct impact on treatment efficacy and vascular access survival. Identifying modifiable risk factors is essential for optimizing prevention strategies and guide clinical decision‐making. This study aimed to identify predictors of tunneled central venous catheter dysfunction through a retrospective multicenter cohort of hemodialysis sessions with repeated measures cross‐sectional, while other cross‐sectional approaches—such as the one presented here—focus on data collected during each HD session to detect early warning signs of dysfunction, following KDOQI 2019 guidelines for vascular access dysfunction definition. The secondary objective was to explore associations. Methods: A multicenter retrospective cohort study with repeated measures was conducted using all hemodialysis sessions performed in 2021 in 18 public hospitals. The unit of analysis was the index session, and the primary outcome was catheter dysfunction in the subsequent session, defined as blood flow < 300 mL/min with associated arterial or venous pressure changes. A mixed‐effects logistic regression with a random intercept for each patient was fitted to account for the repeated hemodialysis sessions. Results: Significant associations were found between catheter dysfunction and lower blood flow rates, elevated venous pressures, line inversion, and catheter placement in the left internal jugular vein. Protective factors included urokinase locking and post‐dilution hemodiafiltration. Higher risk was also linked to interstitial nephropathies and unknown etiologies, whereas prior vascular access reduced the risk of dysfunction. Conclusion: Tunneled central venous catheter dysfunction is a preventable complication when clinical, technical, and hemodynamic parameters are systematically monitored to identify risk factors and guide catheter management. Continuous session‐based monitoring enables early detection and timely intervention. This comprehensive strategy, when combined with pharmacologic management, helps preserve vascular access and enhances treatment outcomes in hemodialysis patients.

Background: Drug combinations with complementary mechanisms of action are able to achieve effective analgesia at lower doses, thereby reducing the risk of adverse effects (AEs). This study evaluated the analgesic efficacy and tolerability of two fixed-dose combinations (FDCs) of ibuprofen/tramadol (IBU/TRA) compared with tramadol and a placebo. Methods: This multicenter, randomized, double-blind, dose-finding, pilot clinical trial compared IBU/TRA (400/37.5 mg and 400/75 mg) with 100 mg of tramadol and a placebo in patients with moderate-to-severe pain following dental surgery. The primary endpoints were pain intensity at 6 h (PI_6h) and the pain intensity difference from baseline to 6 h (PID_6h). PID_7h, the sum of pain intensity differences from baseline to 7 h (SPID_0–7h), pain relief (PAR_7h), total pain relief (TOTPAR_7h), the use of rescue medication and AEs were also assessed. Results: Seventy-two patients were randomized and evaluated. Both FDCs showed superiority over the placebo for PI_6h and PID_6h (p < 0.05) but were not significantly different from 100 mg of tramadol. The statistical superiority of FDCs over the placebo was observed for PID_7h, SPID_0–7h, PAR_7h and TOTPAR_7h. The percentage of patients receiving rescue medication was higher in the placebo (94.1%) and tramadol (52.6%) groups than the FDC groups (35.3% and 36.8% for 400/37.5 mg and 400/75 mg, respectively). A post hoc analysis showed that the FDCs had a superior analgesic efficacy to 100 mg of tramadol in the SPID_0–4h (p < 0.005). The incidence of AEs was comparable between treatment groups. Conclusions: Both FDCs of IBU/TRA provided superior analgesic efficacy compared to the placebo. We propose using SPID_0–4h as the preferred variable for evaluating the efficacy of this type of drug combination.

Background: Intradialytic hypotension is a common complication in haemodialysis, affecting up to 30% of sessions. It results from an imbalance between ultrafiltration and compensatory mechanisms, such as vascular tone and plasma refilling. Volume-controlled biosensors allow for the continuous monitoring of the haemoconcentration, enabling early detection and prevention of hypotension. Methods: A quasi-experimental study was conducted to assess the effectiveness of biosensors in reducing hypotensive episodes. Two biosensors were compared: the Blood Volume Monitor and the Haemomaster system. Data were collected over two four-month periods: before and after biosensor implementation. Nursing staff received specific training, and a protocol for consistent data collection was established. Informed consent was obtained from all eligible participants. The incidence of intradialytic hypotension was compared between sessions with and without biosensor use. Additionally, outcomes were analysed according to biosensor type. Results: A total of 2262 dialysis sessions from 22 patients were analysed. The cohort was 54.5% male, with a mean age of 60 years (SE = 21); 27.3% had diabetes and 81.8% had hypertension. Post-dilution haemodiafiltration was performed in 62.8% of sessions. Intradialysis hypotension occurred in 11.2% of sessions using biosensors compared to 14.0% without (p = 0.021). No significant difference was found between biosensor types (10.8% vs. 11.8%; p = 0.531), although device 1 reached a significantly lower critical blood volume (mean: 10 L; SE = 4 vs. 16 L; SE = 5; p = 0.000). Conclusions: Biosensor use was associated with fewer hypotensive episodes and greater haemodynamic stability. These findings support their integration into routine dialysis practice to improve treatment, safety, and individualised care.

Background/Objectives: Females with cardiovascular disease (CVD) are often misdiagnosed, and they have sex-related psychosocial risk factors that pose specific health risks and affect their adherence to treatment. This study aims to evaluate sex differences in adherence to, and risk prediction for, secondary prevention measures in patients with cardiovascular disease. Methods: A scoping review of the literature was conducted. A search strategy was carried out in the PubMed, Scopus, and Web of Science databases. Articles were selected according to PRISMA guidelines, focusing on studies published within the last five years involving patients with cardiovascular disease and written in English or Spanish. Bias was assessed using the CASPe questionnaire. This project has been registered in the Open Science Framework (OSF) repository under the DOI code 10.17605/OSF.IO/GYDZF. Results: Thirteen articles were retrieved. For hypertension, medication adherence ranges from 25% to 83% in males and from 24% to 80% in females. For ischemic heart disease, the range is 32–74% in males and 32–60% in females. Adherence to physical activity ranges from 21% to 72% in males and 14% to 72% in females. Predictive factors include older age, increased comorbidity, and psychosocial aspects. Conclusions: There is evidence of sex differences in medication adherence for hypertension, ischemic heart disease, and peripheral arterial disease. However, further research is required to identify the factors that predispose individuals to non-adherence.

Background: Paediatric patients are especially prone to experiencing adverse drug reactions (ADRs), and the surgical environment gathers many conditions for such reactions to occur. Additionally, little information exists in the literature on ADRs in the paediatric surgical population. We aimed to quantify the ADR frequency in this population, and to investigate the characteristics and risk factors associated with ADR development. Methods: A prospective observational study was conducted in a cohort of 311 paediatric patients, aged 1–16 years, admitted for surgery at a tertiary referral hospital in Spain (2019–2021). Incidence rates were used to assess ADR frequency. Odds ratios (ORs) were calculated to evaluate the influence of potential risk factors on ADR development. Results: Distinct ADRs (103) were detected in 80 patients (25.7%). The most frequent being hypotension (N = 32; 35%), nausea (N = 16; 15.5%), and emergence delirium (N = 16; 15.5%). Most ADRs occurred because of drug-drug interactions. The combination of sevoflurane and fentanyl was responsible for most of these events (N = 32; 31.1%). The variable most robustly associated to ADR development, was the number of off-label drugs prescribed per patient (OR = 2.99; 95% CI 1.73 to 5.16), followed by the number of drugs prescribed per patient (OR = 1.26, 95% CI 1.13 to 1.41), and older age (OR = 1.26, 95% CI 1.07 to 1.49). The severity of ADRs was assessed according to the criteria of Venulet and the Spanish Pharmacovigilance System. According to both methods, only four ADRs (3.9%) were considered serious. Conclusions: ADRs have a high incidence rate in the paediatric surgical population. The off-label use of drugs is a key risk factor for ADRs development.