A multicenter prospective cohort study of cardiac ultrasound phenotypes in patients with sepsis: Study protocol for a multicenter prospective cohort trial

Abstract

BackgroundSepsis-induced cardiomyopathy significantly increased the mortality of patients with sepsis. The diagnostic criteria for septic cardiomyopathy has not been unified, which brings serious difficulties to clinical treatment. This study aimed to provide evidence for the early identification and intervention in patients with sepsis by clarifying the relationship between the ultrasound phenotype of septic cardiomyopathy and the prognosis of patients with sepsis.MethodsThis was a multicenter, prospective cohort study. The study population will consist of all eligible consecutive patients with sepsis or septic shock who meet the Sepsis 3.0 diagnostic criteria and were aged ≥18 years. Clinical data and echocardiographic measurements will be recorded within 2 h, at the 24th hour, at the 72nd hour, and on the 7th day after admission. The prevalence of each phenotype will be described as well, and their association with prognosis will be analyzed statistically.DiscussionTo achieve early recognition, prevent reinjury, achieve precise treatment, and reduce mortality in patients with sepsis, it is important to identify septic cardiac alterations and classify the phenotypes at all stages of sepsis. First, there is a lack of studies on the prevalence of each phenotype in Chinese populations. Second, each phenotype and its corresponding prognosis are not clear. In addition, the prognosis of patients with normal cardiac ultrasound phenotypes vs. those with suppressed or hyperdynamic cardiac phenotypes is unclear. Finally, this study was designed to collect data at four specific timing, then the timing of occurrence, duration, changes over time, impact to outcomes of each phenotype will probably be found. This study is expected to establish a standard and objective method to assess the ultrasound phenotype of septic cardiomyopathy due to its advantages of visualization, non-invasiveness and reproducibility, and to provide more precise information for the hemodynamic management of septic patients. In addition, this research will promote the clinical application of critical care ultrasound, which will play an important role in medical education and make ultrasound the best method to assess cardiac changes in sepsis.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT05161104, identifier NCT05161104.

Clinical Sepsis Phenotypes in Critically Ill Patients

“…It turns out that, by recognizing and differentiating early septic patients among different hemodynamic phenotypes, hemodynamic support, such as with vasopressors, could be somehow individualized and inotropes infusion and fluid resuscitation could be tailored to the need of each specific phenotype. Currently, there is at least one on-going clinical trial that investigates whether there is an association between the phenotype of septic cardiomyopathy, based on ultrasound characteristics, and the outcome of sepsis [ 95 ]. In addition, ANDROMEDA-2 study investigators seek to determine whether in early septic shock, i.e., <4 h of diagnosis, a peripheral perfusion-guided strategy compared to standard care, applied to different patient phenotypes identified by different clinical and hemodynamic criteria, could improve their outcome (mortality, duration of organ support and hospital length of stay) [ 96 ].…”

Editorial: Advances in cardiovascular medicine: debates and controversies

“…Emerging perspectives on precision medicine have broadened our understanding of sepsis to sepsis-endotypes or sepsis-phenotypes [19]. Potentially, there is a group of patients in whom the cardiovascular system gets affected predominantly [20,21]. A recent study demonstrated that in patients with sepsis-induced cardiomyopathy, veno-arterial ECMO might offer a better outcome [20].…”