Solid Organ Transplantation

This real-world observational study aims to evaluate the effectiveness, safety, and therapeutic drug monitoring (TDM) of liposomal amphotericin B (L-AmB) in solid organ transplant recipients with invasive fungal disease (IFD). IFD is a major cause of morbidity and mortality in transplant recipients because of long-term immunosuppressive therapy and increased susceptibility to opportunistic fungal infections. This is a single-center ambispective cohort study conducted at Sichuan Provincial People's Hospital. The study includes a prospective cohort of solid organ transplant recipients receiving L-AmB therapy and a historical control cohort treated with alternative systemic antifungal regimens. Clinical management and treatment decisions will be determined by treating physicians according to routine clinical practice, and no study-specific intervention will be introduced. The study will collect information on demographic characteristics, transplant type, immunosuppressive regimens, fungal pathogens, infection sites, antifungal treatment strategies, laboratory findings, and clinical outcomes. Particular attention will be given to renal safety, electrolyte abnormalities, and therapeutic drug monitoring of liposomal amphotericin B. Plasma concentrations of L-AmB, treatment modifications, temporary treatment discontinuation, and concentration-related safety and effectiveness outcomes will be recorded during antifungal therapy. The primary outcomes are the 28-day clinical response rate and 84-day all-cause mortality. Secondary outcomes include mycological clearance, acute kidney injury, electrolyte abnormalities, breakthrough fungal infection, treatment discontinuation due to adverse events, liposomal amphotericin B plasma concentrations, and the associations between L-AmB exposure and clinical outcomes or treatment-related toxicities. The study is expected to provide real-world evidence regarding the effectiveness, safety, and pharmacokinetic characteristics of L-AmB in transplant recipients, support optimization of antifungal treatment strategies, and inform individualized dosing and monitoring approaches in this high-risk population.

Main objective: The goal is to to determine the accuracy of Dexcom G7 Continuous glucose monitor system in critically ill patients, undergoing major abdominal surgery and solid organ transplantation, in the intensive care unit. On admission to the intensive care unit or at the end of surgery, two Dexcom G7 sensors are placed in the infraclavicular position. Sensor number 1 will be blinded and will only be active when paired with the receiver, without the ability to monitor glucose levels. Sensor number 2 is used for continuous glucose monitoring and can be used to adjust the insulin dose. Patients will wear the continuous glucose monitoring sensor for a maximum of 10 days, including the time spent in the intensive care unit and the immediate care unit. The study will not interfere with any usual care clinical workflows. Calibration is only performed on an unblinded sensor. The reference method for calibration is the glucose from the blood glucose meter. Calibrate on the first day of monitoring: 4 times a day after approximately 6 hours, or if the blood glucose reading from the blood glucose meter is not within the estimated error range of the continuous glucose monitor (difference greater than 1,5mmol/L). Calibration on days 2 and 3 of monitoring: once in the morning, or when the meter's glucose reading is not within the estimated error range of the continuous glucose monitoring (difference greater than 1,5mmol/L) On subsequent days when the blood glucose meter reading is not within the estimated error range of continuous glucose monitoring (difference greater than 1,5mmol/L). Hypothesis: * Ho: No difference in mean absolute relative difference (MARD) between calibrated and non-calibrated sensors. * Ha: Calibrated sensors have lower mean absolute relative difference (δ = 4%, SD = 5%). Further objectives: To evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety. To identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.

Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases.

AMBU-VAX is a prospective, single-center observational study designed to develop and implement an organizational model for delivering recommended vaccinations within a hospital setting. The study targets adult and elderly patients with chronic diseases or immunocompromising conditions who are eligible for vaccination according to national immunization guidelines. Vaccination is actively proposed during outpatient visits, hospital admissions, or at discharge and, when accepted, administered within the hospital or coordinated with local public health vaccination services. The study aims to evaluate the feasibility, uptake, and completion of hospital-based vaccination pathways and to support integration between hospital and territorial prevention services for vulnerable populations.

Background Pregnancy after all types of solid organ transplantation (SOT) is possible, although these have higher risk of pregnancy complications for mother and child, such as preeclampsia and preterm birth. Thus, the development of the unborn child seems to be affected by the transplant and its consequences such as the immunosuppressive medication use. Worldwide data regarding follow-up after birth is scarce. The very limited existing data existing only in young children are reassuring. However, the investigators hypothesize that there are health risks for the children. Given the side effects of the immunosuppressive medication on patients and limited knowledge from animal studies, the investigators particularly expect cardiovascular effects such as hypertension and kidney damage. These develop over a long time-period and lead late to symptoms. Aims Aim of this study is to gain more insight into the overall health of offspring born after SOT. Primary aim is to assess the cardiovascular health and the presence of kidney disease, and compare these with reference values from the general population or birth cohorts. Secondary aims are the immunological status including the microbiome of the child given the maternal immunosuppressive medication use, and the overall development of the offspring, including qualitative research regarding the quality of life. Third aim is to assess if there are differences in health between offspring born to mothers with a kidney, liver, pancreas (including pancreas islet), heart and lung transplantation (KTx, LiTx, PTx, HTx, LuTx resp.). The investigators also want to establish a biobank for later follow-up research. Study design This will be a cross-sectional monocenter cohort study. All offspring ≥16 years of age born after KTx or LiTx and all offspring born at any age after PTx, HTx and LuTx in the Netherlands will be eligible for inclusion. The investigators estimate that there will be about 150(-220) participants. Before the study visit, participants will be asked to complete a questionnaire. Participants will be invited for a one-time study visit consisting of physical tests (including ultrasound of the kidneys and a 24-hour ambulatory blood pressure measurement) and biological sample (urine, blood and feces) collection, including sample collection for biobanking. Information about the growth and development of the offspring and, if present, diseases and medication use will be collected from the medical files of the general practitioner and pharmacy (LSP) and from data from the youth healthcare check-ups. As a control group pseudoanonymized data from the Lifelines cohort will be used. Deliverables To the best of our knowledge, this will be the first study worldwide that will gather and analyze detailed information about the cardiovascular, kidney and immunological health at a later age (≥16 years) in the offspring born to mothers after KTx, LiTx, PTx, HTx and LuTx. This information will be important for the preconceptional counseling of families with a pregnancy wish after transplantation and thereby contribute to the health of women with a SOT. Next to that, find adverse effects of the pregnancy after transplantation on the offspring are found, the investigators expect there will be modifiable factors and/or early screening/interventions that can reduce these risks and thereby contribute to the health of the offspring.

The objective of this study is to evaluate whether certain proteins, expressed in biological tissues can indict a better understanding of the effect of drugs that are used to treat rejection, and of processes leading to rejection and rejection-free outcomes.

This is a prospective, tissue-based, low-risk, non-pharmacological study that will include adult patients undergoing solid organ transplantation (heart, liver, lung, kidney) followed at the following Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO): * Heart Failure and Transplants (heart-lung) * Internal Medicine for the Treatment of Severe Organ Failures (liver) * Nephrology, Dialysis, and Transplantation (kidney).