Clinical Research Directory

Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)

The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia. It evaluates the efficacy and safety of using Jafron HA-60 and HA380 hemoadsorption cartridges to reduce systemic inflammation in pediatric patients undergoing major heart surgery. Objective This study aims to compare the post-operative inflammatory response in children undergoing cardiac procedures treated with or without a cytokine. Study Population All children \< 18 years of age at the time of enrollment who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass (CPB) with an expected duration of \>180 minutes. Methodology This single-center study will randomly assign patients before surgery into 2 groups: 1 group will receive hemoadsorption treatment plus with standard-of-care (intervention group), while the other group will receive standard-of-care (control group) only. Primary Endpoint: To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period. Secondary Endpoints: 1. Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours 2. PELOD-2 score on ICU admission, at 48 hours post ICU admission 3. ICU and hospital length of stay 4. ICU, hospital, and 28 days mortality 5. Mechanical - ventilation (MV) free days at day 6. Renal replacement therapy (RRT) free days at day 28 7. Vasopressors free days at day 28 8. Acute kidney injury 9. Bleeding complications 10. Post operative liver injury Data Collection: Blood samples will be taken at five timepoints: before surgery, at ICU admission, and at 6, 24, and 48 hours post-procedure . Duration: The study is expected to last 24 months.

Endocarditis Clinical Awareness, Research, and Evaluation in Sweden

The goal of this observational study is to improve the understanding of infective endocarditis by investigating clinical characteristics, treatment strategies, and short- and long-term outcomes in patients diagnosed with infective endocarditis in Sweden. The study includes all adults \>18 years of age diagnosed with infective endocarditis in Sweden since 1997 through linkage of nationwide Swedish health data registers within the Endocarditis Clinical Awareness, Research and Evaluation in Sweden (ENDO-CARE) project. For each patient, four individuals from the general population matched on age and sex are included as population comparators. The main questions it aims to answer are: * Which patients with infective endocarditis benefit from valve surgery, and what is the optimal timing of surgery? * Which patient-, disease-, microbiological-, and socioeconomic factors are associated with short- and long-term outcomes, including mortality, recurrent infective endocarditis, heart failure, stroke, and other major complications? * How do long-term outcomes and life expectancy differ between patients with infective endocarditis and matched individuals from the general population? * How have the incidence, management, microbiology, and outcomes of infective endocarditis changed over time? Researchers will compare surgically and non-surgically treated patients, different clinical subgroups, and patients with infective endocarditis with matched population comparators to identify factors associated with treatment decisions, prognosis, and long-term outcomes. Participants will not undergo any study-specific interventions or examinations. The study is based on linkage of existing nationwide Swedish health care and population registers, including data on hospital admissions, cardiac surgery, microbiology, prescribed medications, dental care, socioeconomic factors, and causes of death.

Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis for Invasive Dental Procedures in Patients With Prosthetic Heart Valves and/or History of Infective Endocarditis

Infective endocarditis (IE) continues to cause serious morbidity and mortality. To reduce its incidence, antibiotic prophylaxis has been recommended before invasive dental procedures in patients with at risk predispositions. Several studies have examined the effect of antibiotic prophylaxis on the incidence of IE and have brought conflicting results. The investigators aim to evaluate the effectiveness of antibiotic prophylaxis before invasive dental procedures to prevent oral streptococcal infective endocarditis in patients with prosthetic heart valves and/or history of IE, using a registry-based, cluster-randomized, controlled trial. In secondary objectives, the investigators aim to analyze changes in dentists' practices.