Prospective longitudinal observational study of the macro and micro haemodynamic responses to septic shock in the renal and systemic circulations: a protocol for the MICROSHOCK - RENAL study.

Introduction: Septic acute kidney injury (AKI) is the most common complication of septic shock and increases mortality. A large body of experimental data suggests alterations in renal perfusion occur, but this is yet to be fully assessed in humans. The aim of the current study is to observe the macro and microcirculations in both the systemic and renal circulations in a cohort of patients with early septic shock.

Methods And Analysis: Single-centre, prospective, longitudinal, observational study of 50 patients with septic shock. Renal microcirculatory assessment will be performed with contrast-enhanced ultrasound, the sublingual microcirculation assessed with incident dark field microscopy and transthoracic echocardiography used to assess global flow. Patients will be enrolled as soon as possible after admission to the intensive care unit and then at +24,+48 and +96 hours. Blood samples of circulatory and renal biomarkers will be collected. Sample groups will be defined by the presence or absence of AKI and then subclassified by the severity (Kidney Disease Improving Global Outcomes (KDIGO) criteria), variables will be compared within and between groups over time.

Ethics And Dissemination: Research Ethics Committee (REC) approval has been granted for this study by Yorkshire and the Humber, Leeds West Research Ethics Committee (18/YH/0371) and due to the nature of the patients enrolled with septic shock, capacity for informed consent is likely to be lacking. Therefore, a personal consultee (friend or relative) will be consulted or a nominated consultee (clinician) in their absence. After capacity is regained, consent will then be sought from the patient in accordance with the Mental Capacity Act, UK (2005). This consent process has been approved following REC review. Results will be published in a relevant peer-reviewed journal and presented at academic meetings.