Clinical trials

Researchers at the Department of Intensive Internal Medicine and the Department of Endocrinology and Diabetology will conduct a study to verify the accuracy and safety of the new Syai Tag system for continuous glucose monitoring in patients in intensive internal care. Almost 150,000 people in Slovenia have diabetes, so keeping a close eye on blood sugar levels is key to preventing complications. The new sensors for continuous monitoring are available over the counter and certified as medical devices. The study will include at least 100 patients who will need blood sugar monitoring during their stay in the intensive care unit. Each patient will have two small sensors placed on each upper arm to continuously measure their blood sugar levels, but these values will not be visible to medical staff. At the same time, healthcare professionals will perform routine blood sugar measurements, and researchers will then compare the accuracy of both methods. The procedure is safe and painless, and patients will receive the same quality of care as usual.

Although the Manchester Triage System (MTS) is widely used and validated internationally, it has some limitations. Its accuracy is moderate, especially for children and the elderly. Rising patient numbers and overcrowded emergency departments increase wait times, sometimes beyond safe limits. In Slovenia, MTS has been in use for 14 years without major updates, despite a significant rise in emergency visits. The yellow triage category (60-minute wait time) includes a very diverse group of patients, some of whom might require faster care. Older patients, in particular, often show atypical symptoms and may be under-triaged. Including rapid bedside lab tests, like blood lactate levels, could improve risk assessment and triage accuracy. Elevated lactate is linked with higher mortality and can help identify critically ill patients more effectively. The proposed study is a prospective, randomized trial involving two groups of patients in the yellow triage category, all of whom will have their capillary blood lactate levels measured. Patients with normal lactate levels will be excluded. Only patients with elevated lactate will be compared. The test group will be re-triaged to the orange category and treated more urgently. The control group, despite also having high lactate levels, will remain in the yellow category, and their elevated lactate values will not be shared with the treating physician. Randomization will be based on the patient's birth date (even days = test group, odd days = control group). Only the nurse will know the result, maintaining physician blinding to avoid the Hawthorne effect-changes in behavior due to awareness of being studied. Standard lab tests will be performed later during treatment as deemed necessary by the attending doctor.

To investigate the pharmacodynamics of light chain of NFL in patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.

Sudden cardiac arrest is one of the leading causes of death in Europe. The recommended treatment for cardiac arrest is cardiopulmonary resuscitation (CPR) and electrical defibrillation with an automated external defibrillator (AED). The chain of survival, which connects all links of basic and additional resuscitation procedures and post-resuscitation care, is important for successful survival. Most patients after out-of-hospital cardiac arrest die in intensive care units due to the withdrawal of active treatment, based on the prediction of a poor neurological outcome. Prognostic indicators are influenced by many factors, including the patient's neurological condition. This should be taken into account when predicting outcome and a multimodal approach based on clinical examination, electrophysiological examinations, imaging studies and biological markers should be used. Based on the professional literature, we asked ourselves the research question of whether it is possible to achieve changes in cerebral oxygen saturation values using simple tests and whether such changes in cerebral oxygen saturation coincide with other methods used to assess neurological outcome and brain damage in patients after primary out-of-hospital cardiac arrest. The patient will have a device installed to detect cerebral oxygen saturation (NIRS) throughout the entire hospitalization period. The level of oxygen in the brain is influenced by various factors: mean arterial pressure, cardiac index, carbon dioxide level in the blood, hemoglobin level in the blood, depth of sedation, body temperature. We will attempt to achieve changes in cerebral oxygen saturation with two simple tests. The first test is based on increasing blood flow through the brain through a controlled gradual infusion of a drug that raises blood pressure. The patient will receive such an infusion immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission. The second test is based on passive elevation of the lower extremities, which results in a transient increased cardiac index produced by the heart and a consequent increase in blood flow through the brain. The second test will also be performed on the patient immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission. Based on the data obtained with the help of the aforementioned tests, we will not decide on the prognosis of the patient's neurological outcome or change or adjust the therapy in any way based on the data obtained. The aim of the study is to demonstrate that changes in cerebral oxygen saturation values in patients after primary out-of-hospital cardiac arrest, obtained with simple tests, coincide with other methods used to assess neurological outcome and brain damage.

Shock is a life-threatening condition which can cause multiple organ failure and even death. One characteristic of shock is low blood pressure which is managed with drugs called vasopressors. Most frequently used vasopressors are noradrenaline, vasopressin and recently also angiotensin II. Angiotensin II is present in the body and has a physiological role in maintaining blood pressure in healthy persons. Renin is an enzyme and a key factor in angiotensin II production in the body. In patients with shock, there is a lack of angiotensin II and an excess of renin in the body. Due to the literature renin has the potential to be a marker of severity of shock. Synthetic angiotensin II is used in patients with shock in whom we cannot normalize the blood pressure with noradrenaline and vasopressin. Regarding scientific data, the use of synthetic angiotensin II reduces the dose of noradrenaline and vasopressin and the incidence of acute kidney injury. The aim of our study is to find out what is the relation between the concentration of renin before and 6 hours after the start of using angiotensin II in patients with shock and their clinical outcome. Since not all patients with shock are responding to angiotensin II, the aim of our study is also to find out which patients could benefit most from synthetic angiotensin II.

The goal of our research project is to measure and compare oxidative stress markers, and systemic inflammatory response in patients undergoing open heart surgery with either conventional or minimally invasive extracorporeal circulation as well as develop pharmacokinetic profiles of different oxidative stress markers for further research on inflammatory response after open heart surgery. The main questions our study aims to answer are : * Does the type of extracorporeal circulation affect the levels of different oxidative stress markers? * Can preoperative and postoperative oxidative stress marker levels be of prognostic values? * Do preoperative and postoperative oxidative stress markers correlate with the clinical outcomes in patients? Researchers will compare the effect of conventional and minimally invasive extracorporeal circulation on clinical outcomes, oxidative stress marker levels, and systemic inflammatory response. Participants will be randomised into two groups (one undergoing arrested-heart surgery with the use of conventional extracorporeal circulation, and the second group undergoing arrested-heart surgery with the use of minimally invasive extracorporeal circulation) and laboratory data, oxidative stress markers, and clinical data will be collected until discharge.