Search Results (39)

Everolimus is approved for the treatment of advanced renal cell carcinoma after VEGF-targeted therapy, metastatic HR-positive/HER2-negative breast cancer in combination with exemestane, and other oncologic indications. However, an intravenous option has not been developed, largely due to its pronounced hydrophobicity and limited oral bioavailability of approximately 15–20%. In this study, we report the development of Sapu003, a novel intravenous Everolimus formulation enabled through the Deciparticle™ platform. A diverse library of mPEG-based block copolymers was evaluated for their ability to encapsulate Everolimus and self-assemble into stable nanoparticle structures. mPEG-Chol was ultimately selected based on its favorable biocompatibility characteristics. In addition to Everolimus, mPEG-Chol and related analogs demonstrated broad formulation compatibility with multiple hydrophobic therapeutics, including Sirolimus, Tacrolimus, Cyclosporine, as well as representative peptides and polyketides. Clinical manufacturing was conducted in a cGMP environment over a 7-day production cycle. Production was carried out under amber light using light-protective vials to reduce drug degradation. The bulk material was sterile-filtered, and subsequent fill/finish/lyophilization operations were performed under temperature-controlled conditions with high precision in fill accuracy (≥98%). After reconstitution, the final product yielding uniform Deciparticles™ that met predefined sterility and particle size criteria. Stability studies demonstrated that the formulation remained stable for at least one month at 5 °C and retained acceptable in-use stability for at least 24 h at room temperature. The process was successfully scaled beyond 10 g, supporting an ongoing Phase 1b open-label dose escalation clinical study of Sapu003 in combination with exemestane in patients with advanced mTOR-sensitive solid tumors (NCT07369505). In vivo evaluation demonstrated strong antitumor efficacy following intravenous administration (QW × 3), with tumor growth inhibition reaching 97–98% in the U-87MG glioblastoma xenograft model. No evidence of phlebitis was observed with repeated tail vein dosing. In this model, Sapu003 dosed weekly showed superior tumor suppression compared with oral Everolimus. Collectively, screening of a mPEG-block copolymer library identified mPEG-Chol as a lead excipient capable of consistently forming stable Deciparticles™ with sub-20 nm mean particle size. The resulting intravenous Everolimus formulation demonstrated scalable manufacturing, favorable stability, and potent antitumor activity in preclinical models, supporting further clinical evaluation of Sapu003 in advanced solid tumors. Full article

Background/Objectives: Routine replacement of peripheral intravenous catheters (PIVCs) every 72–96 h remains common practice despite growing guideline support for clinically indicated replacement. Evidence from Asian healthcare settings remains limited. Methods: A non-inferiority, cluster-randomised crossover trial was conducted from January to July 2021 across eight wards of a tertiary care hospital in South Korea. Adults requiring peripheral IV therapy for ≥96 h were allocated to routine 96-h replacement or clinically indicated replacement. The primary outcome was phlebitis incidence; a non-inferiority margin of 5% (absolute risk difference) was prespecified. Results: Among 1324 participants, phlebitis occurred in 12.6% (clinically indicated) vs. 11.7% (routine) (ARD 1.44 pp, 95% CI −1.47 to 4.35), meeting non-inferiority. No catheter-related bloodstream infections were observed in either group. The clinically indicated group required fewer catheter insertions (mean 1.77 vs. 2.16; p < 0.001) and had longer dwell times (mean 112.0 vs. 89.6 h; p < 0.001). Conclusions: Clinically indicated PIVC replacement was non-inferior to routine scheduled replacement for phlebitis and was associated with fewer insertions and longer dwell times, supporting its use in routine clinical practice. Full article

Background/Objectives: To develop and validate a multidimensional risk assessment scale for identifying patients at risk of peripheral venous catheter (PVC)-associated phlebitis. Methods: This methodological study followed a two-phase design. In Phase 1 (scale development), an initial item pool of 39 candidate items was generated from a focused literature review and refined using the Lawshe technique with 20 expert raters. Data were collected from 729 hospitalized patients, who contributed 1008 PVCs between February and September 2021. Because the scale items are catheter-level, the PVC was the unit of analysis: 502 PVCs (from 380 patients) were used for exploratory factor analysis (EFA), and 506 PVCs (from 349 patients) for confirmatory factor analysis (CFA). In Phase 2 (clinical application), the finalized scale was administered to a separate, independent cohort of 208 patients between September and October 2021 alongside the Infusion Nurses Society (INS) Phlebitis Scale. Reliability was assessed using the Kuder–Richardson 20 (KR-20) coefficient, and discriminative performance was evaluated with Receiver Operating Characteristic (ROC) curve analysis. Results: EFA and CFA confirmed a three-factor structure comprising 14 items distributed across Individual, Chemical, and Mechanical risk domains. The instrument demonstrated strong internal consistency (KR-20 = 0.823) and excellent discriminative accuracy (AUC = 0.898), with an optimal cut-off of 20.5 (sensitivity 87%, specificity 91%). All CFA fit indices met the conventional acceptability thresholds (χ²/df = 3.249; GFI = 0.943; AGFI = 0.914; CFI = 0.942; NFI = 0.919; IFI = 0.943; TLI = 0.925; RMSEA = 0.067). In Phase 2, scale scores correlated significantly with the INS Phlebitis Scale (r = 0.794, p < 0.001). Conclusions: The Risk Assessment Scale for PVC-Associated Phlebitis is a valid and reliable instrument with strong psychometric properties. It enables early identification of high-risk patients and supports targeted preventive strategies in clinical practice. Full article

Background and Objectives: The presence of comorbidities in both the pre- and post-diagnostic periods is a critical consideration in the diagnosis and management of patients with cancer. This study aimed to investigate the prevalence and burden of pulmonary and extrapulmonary comorbidities in patients diagnosed with lung cancer (LC) and malignant pleural mesothelioma (MPM). Materials and Methods: The data were obtained from official patient records of the Turkish Ministry of Health. Patients diagnosed with either lung cancer (LC) or malignant pleural mesothelioma (MPM) between 2015 and 2018 were included in the study. Comorbidities were classified as pulmonary or extrapulmonary. Results: A total of 74,835 patients with LC and 1678 patients with MPM were included. The burden of comorbid conditions increased significantly in the post-diagnostic period in both males and females across both cancer types. When the two cancer groups were compared with respect to diagnostic periods, comorbidities such as hypertension (HT), phlebitis/venous thrombosis/thrombophlebitis, pulmonary embolism, pneumothorax, and pleural effusion were significantly more prevalent in the MPM group (p < 0.05). Compared with the pre-diagnostic period, the comorbidity risk in LC was highest for pulmonary embolism, ARF, and pneumonia in the post-diagnostic period, whereas renal failure was the most frequent comorbidity in the MPM group (p < 0.001 and p = 0.024). When comparing changes in comorbidity burden between sexes in the lung cancer group, male patients had higher frequencies of pulmonary embolism, pneumonia, pneumothorax, and coronary artery disease than females. In contrast, in the female lung cancer group, the prevalence of chronic renal failure was higher than in males (OR = 2.14 vs. 2.00), whereas acute renal failure was more prominent in the male patient group (OR = 2.64 vs. 1.94). In gender-based comparison of comorbid conditions among patients with MPM, the risk of renal failure was higher in females than in males (CRF and ARF respectively: OR = 2.63 vs. 2.16 and OR = 6.80 vs. 5.44). Additionally, increased rates of COPD were observed in male patients within this group (OR = 1.93 vs. 1.81). Conclusions: Patients with LC and MPM are burdened not only by their primary malignancies but also by a wide spectrum of comorbidities, particularly in the post-diagnostic period. Comprehensive knowledge of comorbid conditions is essential for clinicians to guide clinical decision-making, anticipate disease progression, and optimize treatment strategies, thereby informing national healthcare policies. Future studies incorporating matched control groups or longitudinal designs with standardized surveillance protocols may help conduct better research. Full article

Background: Venous catheters are standard devices in clinical practice. However, their use is not exempt from possible errors and complications. In addition, using them effectively is key to avoiding complications such as infection or phlebitis. Objectives: To determine the frequency of appropriate venous catheters chosen based on the drug and treatment duration in hospitalized patients in a region with 154,000 inhabitants. Methods: A cross-sectional design was carried out between 14 and 28 February 2020, in patients with a peripheral or central intravenous catheter admitted to the acute care unit. Variables collected were related to the catheters, patients, and nurses. Results: One hundred and eighty-eight patients were included, with 319 catheters inserted by 68 nurses. Seventeen patients (8.8%) were ruled out due to the lack of data on the medication administered. Finally, data from 171 patients were included in the final analysis, with 297 catheters inserted. Of them, 246 catheters (82.8%) were inadequate. Discussion: In this point-prevalence study, catheter inadequacy affected more than four out of five catheters and was mainly linked to the use of peripheral catheters for high-risk IV medications and/or for treatments extending 7 days or more. Conclusion: The selection of venous catheters in acute care units is not usually adequate since many peripheral catheters are placed in patients who require intravenous medication during a prolonged period or who are receiving risk medication. Full article

Background/Objectives: Peripheral intravenous catheters are commonly employed to administer intravenous therapy to hospitalized patients. However, their use can result in complications, with phlebitis occurring in approximately 11% of cases and bloodstream infections in about 0.18%. This study aimed to enhance PIVC management in a local hospital by implementing a comprehensive care bundle to mitigate these complications. Methods: This quality improvement study involved the collection of data from 1330 PIVCs in adult patients, both prior to and following the implementation of the intervention. Data collection occurred between June 2022 and November 2023, employing the validated Peripheral Intravenous Catheter-Mini Questionnaire (PIVC-miniQ). This instrument comprises 16 observation points that assess phlebitis-related signs and symptoms, the integrity of PIVC dressings and IV connections, and the adequacy of documentation. Results: The prevalence of phlebitis decreased from 15.1% at baseline to 9.4% post-intervention (p = 0.018). Significant predictors of phlebitis included the intervention, ward, gender, and PIVC gauge. Improvements were also noted in PIVC dressing and IV connection practices, as well as documentation standards (p < 0.001). Closed integrated PIVCs outperformed ported PIVCs in the PIVC-miniQ scores after the intervention (p < 0.001). A statistically significant difference was observed in the mean PIVC-miniQ sum score post-intervention compared to baseline (p < 0.001). Conclusions: This study indicates that implementing a care bundle can enhance the quality of PIVCs and reduce the prevalence of phlebitis. Further high-quality research is needed to identify the most effective care bundles for preventing PIVC-related complications. Full article

Immunoglobulin G4-related disease (IgG4-RD) is a systemic fibroinflammatory condition marked by tumefactive lesions, IgG4+ plasma cell-rich infiltrates, storiform fibrosis, and obliterative phlebitis. Its multisystem involvement and overlap with malignancies, infections, and immune disorders complicate diagnosis despite recent classification advances. This study summarizes diagnostic challenges, highlights the role of histopathology as per the 2019 classification criteria established by the American College of Rheumatology and the European League Against Rheumatism (ACR/EULAR), and explores emerging tools to improve diagnostic accuracy. ACR/EULAR classification emphasizes three cardinal histopathological features (storiform fibrosis, obliterative phlebitis, or dense lymphoplasmacytic infiltrates) combined with an IgG4+/IgG+ plasma cell ratio >40% and organ-specific IgG4+ thresholds. While serum IgG4 levels are often elevated, their poor specificity necessitates confirmatory biopsy. Diagnostic limitations include sampling variability due to patchy fibrosis, interobserver discrepancies in immunohistochemical interpretation, and differentiation from mimics like lymphoma. Emerging solutions incorporate novel biomarkers (plasmablasts, anti-annexin A11) and advanced techniques (flow cytometry, digital pathology). Future research directions should focus on AI-assisted pattern recognition, multi-omics profiling, and organ-specific criteria refinement. While histopathology remains the diagnostic cornerstone, a multidisciplinary approach integrating clinical, radiological, and laboratory data is vital. Innovations in biomarkers promise improved diagnostic accuracy and personalized care, balancing novel advancements with foundational pathological evaluation. Full article

Most cardiological drugs need intravenous administration to have a fast effect in an emergency. Intravenous administration is linked to complications, such as tissue infiltration and thrombophlebitis. Aiming to supply an effective tool for the development of appropriate policies, this systematic review provides practical recommendations about the diluent, pH, osmolarity, dosage, vesicant properties, and phlebitis rate of the most commonly used cardiological drugs evaluated in randomized controlled trials (RCTs) till 31 August 2024. The authors searched for available IV cardiological drugs in RCTs in PUBMED EMBASE^®, EBSCO-CINAHL^®, and Cochrane Controlled Clinical trials. Drugs’ chemical features were obtained online, in drug data sheets, and in scientific papers, establishing that the drugs with a pH of <5 or >9, an osmolarity > 600 mOsm/L, and a high incidence of phlebitis reported in the literature, as well as vesicant drugs, require utmost caution during administration. A total of 857 papers were evaluated and 316 studies were included. A total of 84 cardiological drugs were identified, of which only 31 (37%) can be safely infused via a peripheral route. Thrombolytics and anticoagulants are considered the safest classes of drugs, with only one drug flagged as a “red flag” medication. However, a higher percentage of drugs in other categories meet the “red flag” criteria, including antiarrhythmics (52%), antiplatelet agents (67%), diuretics (67%), antihypertensives (70%), other drugs (77%), and vasoconstrictors and inotropics (89%). Understanding the physicochemical properties of cardiological drugs is essential for significantly improving patient safety and preventing administration errors and local side effects. Full article

The management of nursing care regarding patients’ vascular access is a priority. This study determines the contribution of the variables involved in the quality of care and maintenance of vascular access (VA) devices in admitted patients in the Valencian Community. Methods: Using the STROBE statement, an observational, cross-sectional study was conducted on 1576 VA devices. Data were collected using the INCATIV Questionnaire. We performed a multivariate analysis of the questionnaire variables. Results: In total, 50% had a good or very good assessment of the VA condition. This was positively correlated with anatomical location, dressing type, dressing date record, use of needle-free connectors (NFCs), date of last dressing change, presence of phlebitis, visibility of the insertion site and characteristics of the dressing’s condition (p < 0.001). The model indicated that the presence of phlebitis was the clearest predictor of a poor VA care assessment (OR = 20.579), followed by no visibility of the insertion site (OR = 14.209). Results also indicated that uncovered VA lumens or no NFCs used were related to a negative quality assessment. Conclusion: By managing and controlling these variables, the likelihood of providing optimal care is ensured. This enables the establishment of a standardised care approach for all nursing professionals and the building of a new quality indicator. Full article

Background: Phlebitis related to peripheral venous catheters (PVCs) is a common complication in patients who require these devices and can have important consequences for the patients and the healthcare system. The management and control of the PVC-associated complications is related to nursing competency. The present study aims to determine, at the national level in Spain, the consensus on the assessment, treatment, and follow-up of PVC-related phlebitis and the importance of the actions taken. Method: A three-round Delphi technique was used with clinical care nurses who are experts in the field of in-hospital intravenous treatment in Spain. For this, an online questionnaire was developed with three open-ended questions on the dimensions of phlebitis assessment, treatment, and follow-up. For the statistical analysis of the results, frequencies and percentages were used to determine consensus, and the measures of central tendency (mean, standard deviation, and the coefficient of variation) were used to rank importance. The coefficient of variation was set as acceptable at ≤30%. Results: The final sample was 27 expert nurses. At the conclusion of round 3, actions were ranked according to their importance, with six items included in the PVC-related phlebitis assessment (symptomatology/observation, redness, the Maddox scale, induration, temperature, and pain), two in treatment (catheter removal, pentosan polysulphate sodium ointment + application of cold), and just one in follow-up (general monitoring + temperature control). Conclusions: There is a major disparity in relation to the PVC-related phlebitis assessment, treatment, and follow-up actions. More clinical studies are therefore needed to minimise the complications associated with the use of PVCs, given their impact on the quality of care and patient safety and their economic cost. Full article

Immunoglobulin G4-related disease (IgG4-RD) is a novel fibroinflammatory disorder characterized by enlargement of the involved organs, elevated IgG4 levels, and abundant infiltration of IgG4-positive plasma cells. Indeed, primary colon cancers arising from IgG4-RD are rare. This case report describes a rare occurrence of simultaneous colorectal cancer and IgG4-RD in the same lesion in a 62-year-old male patient. The patient underwent a right hemicolectomy under the suspicion of primary colon cancer. The mass was grossly well-defined and yellowish tan, and the background colon was fibrotic. Microscopically, the tumor cells showed glandular differentiation characteristic of adenocarcinoma in a background of dense lymphoplasmacytic infiltration with fibrosis and obliterative phlebitis in the pericolic fat tissue. IgG4 immunohistochemical staining showed diffuse positivity in infiltrating plasma cells. The patient was administered adjuvant chemotherapy and prednisolone therapy. The patient’s serum IgG4 levels gradually decreased, and a follow-up positron emission tomography-computed tomography scan 1 year after surgery showed no evidence of local or distant recurrence of colorectal cancer. IgG4-RD occurring concurrently with primary colon adenocarcinoma has not been reported. Increased awareness of this rare coexistence can guide clinicians in navigating diagnostic complexities and selecting optimal therapeutic strategies. Full article

Phlebitis secondary to vascular access is one of the most frequent complications in hospital care. This study aims to evaluate the scientific activity related to this complication through a bibliometric analysis. The search was performed on a single day, 23 January 2023, to ensure the inclusion of all articles and to avoid bias caused by the daily updates of the open access database. The data were recovered from Web of Science. The sample comprised a total of 1596 publications that met the inclusion criteria. The United States was the country with the largest number of publications, citations, and international cooperation with respect to phlebitis and vascular access. The most important author was Rickard CM. Of all the publications selected, a total of 1586 (99.37%) were original articles. The highest number of articles on the subject was recorded in 2021, and the most common research areas were General Internal Medicine and Nursing. The analysis of the clusters (KeyWords Plus and Author keywords) and co-occurrences enabled identification of areas of interest and their possible development. These areas included the prevention, risk, and associated complications of catheter-associated phlebitis. Other aspects that are a priori relevant, such as assessment and treatment, were found to be little investigated. While research on this subject is increasing internationally, more collaborations are still required between researchers, as well as new approaches related to the management of catheter-associated phlebitis. The dimensions that should continue to be considered in new research, according to the findings of this review, are instruments for phlebitis assessment and their validation, and the treatments to follow in the case of established phlebitis. For this reason, the bibliometric information presented is key for new or consolidated researchers in the field, especially because of its practical and clinical implications for patient safety. Full article

Background: Vasopressors are frequently utilized for blood pressure stabilization in patients with cardiogenic shock (CS), although with a questionable benefit. Obtaining central venous access is time consuming and may be associated with serious complications. Hence, we thought to evaluate whether the administration of vasopressors through a peripheral venous catheter (PVC) is a safe and effective alternative for the management of patients with CS presenting to the intensive cardiovascular care unit (ICCU). Methods: A prospective single-center study was conducted to compare the safety and outcomes of vasopressors administered via a PVC vs. a central venous catheter (CVC) in patients presenting with CS over a 12-month period. Results: A total of 1100 patients were included; of them, 139 (12.6%) required a vasopressor treatment due to shock, with 108 (78%) treated via a PVC and 31 (22%) treated via a CVC according to the discretion of the treating physician. The duration of the vasopressor administration was shorter in the PVC group compared with the CVC group (2.5 days vs. 4.2 days, respectively, p < 0.05). Phlebitis and the extravasation of vasopressors occurred at similar rates in the PVC and CVC groups (5.7% vs. 3.3%, respectively, p = 0.33; 0.9% vs. 3.3%, respectively, p = 0.17). Nevertheless, the bleeding rate was higher in the CVC group compared with the PVC group (3% vs. 0%, p = 0.03). Conclusions: The administration of vasopressor infusions via PVC for the management of patients with CS is feasible and safe in patients with cardiogenic shock. Further studies are needed to establish this method of treatment. Full article

Feline coronavirus (FCoV) is a ubiquitous RNA virus of cats, which is transmitted faeco-orally. In these guidelines, the European Advisory Board on Cat Diseases (ABCD) presents a comprehensive review of feline infectious peritonitis (FIP). FCoV is primarily an enteric virus and most infections do not cause clinical signs, or result in only enteritis, but a small proportion of FCoV-infected cats develop FIP. The pathology in FIP comprises a perivascular phlebitis that can affect any organ. Cats under two years old are most frequently affected by FIP. Most cats present with fever, anorexia, and weight loss; many have effusions, and some have ocular and/or neurological signs. Making a diagnosis is complex and ABCD FIP Diagnostic Approach Tools are available to aid veterinarians. Sampling an effusion, when present, for cytology, biochemistry, and FCoV RNA or FCoV antigen detection is very useful diagnostically. In the absence of an effusion, fine-needle aspirates from affected organs for cytology and FCoV RNA or FCoV antigen detection are helpful. Definitive diagnosis usually requires histopathology with FCoV antigen detection. Antiviral treatments now enable recovery in many cases from this previously fatal disease; nucleoside analogues (e.g., oral GS-441524) are very effective, although they are not available in all countries. Full article