Use of Levosimendan in Right Ventricular Dysfunction due to Sepsis and Septic Shock: A Research Protocol

Abstract

Introduction: Sepsis is a clinical condition that results from infection and systemic inflammatory response syndrome, which can progress to severe sepsis and septic shock. This condition leads to myocardial dysfunction and increased mortality rates, particularly in cases of septic shock. Inotropic agents are beneficial in improving cardiac contractility and cardiac output in septic shock. Need for the study: It is important to address myocardial dysfunction in sepsis and septic shock, as these conditions significantly contribute to patient morbidity and mortality. Calcium desensitisation is a key factor in the pathophysiology of septic myocardial depression, leading to impaired cardiac function. Levosimendan, a novel calcium sensitiser, offers a promising therapeutic option due to its unique pharmacologic and biologic profile. By enhancing calcium sensitivity in cardiac myocytes, levosimendan may improve cardiac function without the detrimental side-effects associated with traditional inotropic agents. Aim: The research protocol was planned with an aim to analyse the impact of intravenous levosimendan on Right Ventricular (RV) dysfunction in patients with septic shock. Materials and Methods: This prospective observational study aims to assess the effect of levosimendan on the improvement of RV dysfunction in patients with septic shock who are admitted to the intensive care unit of Acharya Vinoba Bhave Rural Hospital, DMIHER (DU) Sawangi (Meghe), Wardha, Maharashtra, India from July 2023 to March 2025, 45 patients who meet the inclusion criteria will be recruited. Transthoracic Echocardiography (TTE) will be performed using standard measures to calculate RV function. Patients diagnosed with RV dysfunction will be administered levosimendan, followed by a re-evaluation of RV function at designated intervals. Statistical analysis will be conducted using R software, and a paired t-test will be employed to determine significant differences at pre- and post-intervention timelines for the outcome variables of echocardiographic parameters, including Tricuspid Annular Plane Systolic Excursion (TAPSE), EF, RV Fractional Area Change (FAC), and Tricuspid Regurgitant jet Velocity (TRV), at a 5% level of significance.