Protocol of the sepsivit study: a prospective observational study to determine whether continuous heart rate variability measurement during the first 48 hours of hospitalisation provides an early warning for deterioration in patients presenting with infection or sepsis to the emergency department of a Dutch academic teaching hospital.

Introduction: One in five patients with sepsis deteriorates within 48 hours after hospital admission. Regrettably, a clear tool for the early detection of deterioration is still lacking. The SepsiVit study aims to determine whether continuous heart rate variability (HRV) measurement can provide an early warning for deterioration in patients presenting with suspected infection or sepsis to the emergency department (ED).

Methods And Analysis: The protocol of a prospective observational study in the ED. We will include 171 adult medical patients presenting with suspected infection or sepsis and at least two systemic inflammatory response syndrome criteria. Patients with known pregnancy, cardiac transplantation or not admitted to our hospital are excluded.High sample frequency ECG signals (500 Hz), respiratory rate, blood pressure and peripheral oxygen saturation will be recorded continuously during the first 48 hours of hospitalisation using a bedside patient monitor (Philips IntelliVue MP70). Primary endpoint is patient deterioration, defined as the development of organ dysfunction, unplanned intensive care unit admission or in-hospital mortality. The ECG data will be used for offline HRV analysis. We will compare the HRV between two groups (deterioration/no deterioration) and analyse whether HRV provides an early warning for deterioration. Furthermore, we will create a multivariate predictive model for deterioration based on heart rate, respiratory rate and HRV. As planned secondary analyses, we (1) perform a subgroup analysis for patients with pneumosepsis and urosepsis and (2) determine whether HRV using lower sample frequencies (1 Hz or less) suffices to predict deterioration.

Ethics And Dissemination: The Institutional Review Board of the University Medical Center Groningen granted a waiver for the study (METc 2015/164). Results will be disseminated through international peer-reviewed publications and conference presentations. A lay summary of the results will be provided to the study participants.

Trial Registration Number: NTR6168; Pre-results.