Orihuela

Researchers are evaluating whether a structured training program for intensive care unit ICU staff can reduce health problems known as post-intensive care syndrome PICS in adults after they leave the hospital. PICS includes new or worsened physical, thinking, or emotional difficulties following serious illness, which can affect daily life, independence, memory, mood, and overall quality of life. This multicenter study compares patients treated before and after ICU staff training, focusing on whether the training reduces PICS three months after hospital discharge. The study also compares standard training on the ABCDEF care bundle with an expanded A-Z bundle that includes additional care elements like nutrition, sleep, infection prevention, safety, and psychological support. The study involves a cluster-randomized design where entire ICUs are assigned to receive training on either the standard ABCDEF bundle or the expanded A-Z bundle. The training program for ICU staff includes a month-long online course with educational materials, checklists, pocket guides, and visual reminders, plus face-to-face sessions to reinforce learning. After training, ICUs continue usual care while researchers track how often the trained care practices are followed during patients ICU stays, up to 21 days or until discharge or death. Follow-up visits for patients occur at 1, 3, 6, and 12 months after hospital discharge. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. They will undergo tests and questionnaires on physical health, memory, mood, and quality of life during follow-up visits. Data collection includes ICU care details and patient outcomes, monitored using electronic forms with quality checks. The main outcome measured is the number of participants who develop PICS three months after discharge. Secondary outcomes include adherence to care bundles, incidence of delirium, and quality of life assessments at various timepoints. The study runs until 2028 and maintains ethical and data protection standards throughout.

Researchers are evaluating a new approach to prevent heart and blood vessel problems in patients with inflammatory rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and systemic lupus erythematosus. These patients have a 50% higher chance of cardiovascular events compared to the general population, and current risk scores often underestimate their true risk. This phase IV clinical trial aims to test if using carotid ultrasound to detect early artery disease can better identify patients at high risk and improve prevention. Participants aged 50 years and older with inflammatory rheumatic diseases and low-to-moderate cardiovascular risk will be randomly assigned to either receive a carotid ultrasound or follow standard care based on current guidelines. Those in the ultrasound group found to have carotid plaques will be classified as very high risk and started on high-intensity statin therapy to lower LDL cholesterol below 55 mgdL. Patients without plaques and those in the control group will receive care according to the European Society of Cardiology 2021 recommendations. The study will last 48 months with ongoing monitoring. Throughout the study, patients will have regular visits to track their health and treatment effects. Those needing lipid-lowering therapy will have monthly visits during treatment adjustment, then every six months until the study ends. All patients will be monitored for major cardiovascular events such as heart attacks, strokes, and hospitalizations over four years. Safety and side effects will also be evaluated, aiming to see if the ultrasound-based strategy better prevents heart problems compared to standard care.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are comparing two sedation methods for critically ill patients on mechanical ventilation inhaled isoflurane delivered via the Sedaconda ACD-S system versus intravenous propofol. This Phase IV, low-intervention, open-label, randomized controlled trial aims to evaluate which method leads to more ventilator-free days within 28 days post-randomization. The study focuses on patients expected to need deep sedation and mechanical ventilation for over 48 hours in the intensive care unit ICU. Participants will be randomly assigned to one of two groups. One group receives inhaled isoflurane starting at 3 mLh, adjusted to reach a target sedation level without exceeding 14 mLh, guided by end tidal isoflurane concentration. Short periods with higher concentrations may be used. The other group receives intravenous propofol starting at 0.5-1 mgkgh, carefully increased to reach the target sedation without exceeding 4 mgkgh. If sedation targets are not met, a secondary hypnotic may be added in either group. During the study, participants will be monitored for ventilator-free days at 28 days, ICU-free days, time to extubation, sedation effectiveness, use of additional sedatives, and delirium incidence and duration within 28 days. Researchers will also assess mental, cognitive, and quality of life outcomes at 90 days after hospital discharge. Safety, including treatment-related adverse events and mortality up to 60 days, will be tracked. The trial includes 620 patients across multiple centers, with data collected throughout the ICU stay and follow-up periods.

Researchers are evaluating the safety and effectiveness of Beltaven, a subcutaneous allergen-specific immunotherapy, in patients allergic to Apis mellifera, Polistes dominula, or Vespula species. This prospective, open, multi-center observational study includes children and adults receiving care in routine medical practice. The study focuses on patients who have had systemic allergic reactions to hymenoptera stings, aiming to better understand how Beltaven works in real-world settings. Participants receive Beltaven as part of their usual medical care, following a 3-week cluster dosing schedule. The study monitors clinical effectiveness over a 9-month period to assess how the treatment impacts allergic responses. This non-interventional design means that treatments are given as prescribed by doctors, without altering standard care practices. The study collects data during this period to provide insights into Beltavens use in everyday healthcare. During the study, participants will undergo allergy testing including intradermal tests and specific IgE blood tests to confirm their allergy. Researchers will monitor safety and treatment outcomes throughout the 9 months of therapy. The primary measurement is the clinical effectiveness of Beltaven given subcutaneously. Participants health status and any reactions will be observed, with ongoing assessments to ensure safety and support comprehensive data collection over the study timeline.