German Clinical Trials Register

Acronym/abbreviation of the study

SepCOR

URL of the study

No Entry

Brief summary in lay language

What is the aim of the study? The objectives of the study are to investigate the frequency of cardiac involvement in sepsis and the association with the elevation of cardiac-specific laboratory parameters. Furthermore, it will be investigated whether there are treatment outcome-relevant risk constellations with regard to cardiac involvement in sepsis. Scientific Background The human body reacts to infections with a complex inflammatory response. On the one hand, this inflammatory reaction is necessary for the body to heal - but if it is too strong and uncontrolled, it can assume life-threatening proportions for the body. Many aspects of the inflammatory reaction are not yet understood and are therefore of great interest for the further development of medical therapy. The damage to the heart in the context of this misregulated inflammatory reaction is still poorly understood. The ultrasound examination of the heart, known as echocardiography, can provide important insights. Together with a image processing method, "speckle tracking", can make an important an important contribution to a better understanding of this cardiac damage. can be provided. What medical problem is being investigated? The heart can be damaged by a dysregulated inflammatory reaction. be damaged. This damage or involvement of the heart is called septic cardiomyopathy. The heart can no longer pump sufficient blood through the vascular system and becomes exhausted. This can result in an undersupply of oxygen and nutrients to the organs, which can and nutrients to the organs, which can then lead to serious serious disturbance of the organ functions. As a rule, this weakening of the heart is usually temporary, but can take a severe course, which can lead to death. The early and accurate detection of this septic cardiomyopathy is cardiomyopathy is not yet possible with certainty. The combination of echocardiography with a blood test for certain cardiac-specific specific parameters could contribute to a better diagnosis and thus diagnosis and thus enable better therapy through earlier detection. therapy. How does the study work? Patients are to be examined for the study a total of echocardiography (ultrasound of the heart) on four occasions in the intensive care unit or, in the course of the study, in the normal ward (day 1, 5, 12 and 30 after inclusion in the study). A blood sample will be taken at each of the appointments. The blood will be analyzed for the concentration of cardiac-specific and other biomarkers (troponin T and I, NTproBNP, CK, CK-MB, DLL-1, HFABP, free circulating histones, microparticles) are present. Since the concentration of biomarkers is influenced by factors, including the current health status of the patient, four blood current health condition, four blood samples are required to obtain are required to gain insight into the concentration trend. At each appointment, approx. 30 ml of blood is taken, i.e., a total of approx. 120 ml of blood. 90 days after study inclusion the patients or their family doctor will be contacted to ask about their health status.

Brief summary in scientific language

In sepsis, a misdirected systemic immune response occurs in response to an infection, leading to organ dysfunction. If sepsis is accompanied by circulatory failure with consequent tissue dysperfusion, this is referred to as septic shock. As a distributive form of shock, this is usually due to a loss of fluid into the tissues and pathological dilatation of the vessels. In addition, there may be a change in the pumping function of the heart, known as septic cardiomyopathy, which can impair circulatory function and significantly complicate therapy. The diagnosis and optimal therapy of this component of the disease has not yet been adequately studied. Detection of septic cardiomyopathy by conventional echocardiographic methods is limited by the complexity of septic circulatory failure. Special echocardiographic examinations, so-called strain imaging, could be novel indicators of severe cardiac involvement in the course of sepsis and thus allow the development of targeted therapy. However, these examination methods are currently not part of the clinical standard of care in intensive care units. The aim of our clinical study in septic patients is first to characterize the changes in cardiac function by means of strain imaging (echocardiography, non-invasive) in septic patients in a surgical intensive care unit. In particular, the time course of the changes in cardiac function should be recorded. In addition, the results will be correlated with cardiac damage markers in the plasma of the patients as well as with outcome parameters in order to identify risk constellations in the future. The analysis will be purely descriptive. For this purpose, 100 patients with sepsis will be included in an exploratory design. Blood samples will be taken on the day of inclusion (day 1) and on the following days (day 3 and 12) from inserted catheters. The strain imaging parameters "Global Longitudinal Strain, GLS" and "Global Circumferential Strain, GCS" will be measured to increase the understanding of the pathophysiological processes and correlations regarding cardiac involvement during sepsis. Repeated measurements will be used to estimate the temporal dynamics of the parameters. The data will not be made available to the treating physicians in order to avoid an influence on therapy decisions.