None listed
Conditions
Brief summary
Severe sepsis accounts for significant morbidity and mortality in the community and is a large contributor to healthcare costs. The hallmark of severe sepsis is organ failure or shock. Patients with community acquired sepsis are initially assessed in the Emergency Department (ED). The signs of early organ dysfunction or shock may not be present when the patient is seen in in the ED, leading to delayed treatment and increased costs. This study will investigate a new technique to measure tissue oxygenation (StO2) non-invasively called near-infrared spectroscopy (NIRS) using a commercially available device. StO2 is a measure of impaired circulation and may be an early indicator of developing shock. We will measure StO2 in the ED in patients who are being admitted to hospital with sepsis. The study hypothesis is that StO2 is associated with organ failure and so can be used to identify patients at risk in this setting. We aim to recruit 300 patients presenting to two metropolitan Emergency departments in Western Australia during this study. This study is investigator initiated and has been designed and funded independently from the manufacturer of the NIRS device or any other industry sponsor.
Interventions
Tissue oxygen saturation (StO2) will be measured non-invasively in the muscles of the hand using near infrared spectroscopy. This gives an estimate of the adequacy of the circulation and may be an early indicator of developing shock. These measurements take a few seconds to perform and will be taken on initial assessment in the Emergency Department and three hours subsequently in patients presenting to the Emergency Department with infections. The aim is to evaluate if StO2 is useful to identif
Tissue oxygen saturation (StO2) will be measured non-invasively in the muscles of the hand using near infrared spectroscopy. This gives an estimate of the adequacy of the circulation and may be an early indicator of developing shock. These measurements take a few seconds to perform and will be taken on initial assessment in the Emergency Department and three hours subsequently in patients presenting to the Emergency Department with infections. The aim is to evaluate if StO2 is useful to identify patients who are at risk of deteriorating and developing organ failure in the subsequent days following admission to hospital.
Sponsors
University of Western Australia
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Suspected or proven infection plus 2 or more of (i) temperature >38 of <36 degrees celsius (ii) heart rate >90bpm (iii) respiratory rate >20/min (iv) total white blood count >12x109/L or <4x109/L, and being admitted to hospital for intravenous antibiotics. Patients will be included if they meet criteria for uncomplicated sepsis, severe sepsis (associated with organ dysfunction) and/or septic shock. Criteria for severe sepsis or septic shock as follows: Case definition for sepsis as above PLUS either - 1. Organ failure defined as SOFA score of 2 or more e.g. acute respiratory failure, renal failure, or altered mental state 2. Shock defined as (a)systolic blood pressure (SBP) <90mmHg, or mean arterial pressure (MAP)<65mmHg or heart rate >SBP (shock index >1) despite 20-30ml/kg isotonic fluid bolus or (b) serum lactate >4mmol/L.
Exclusion criteria
Age <18 years Expected to die from other cause (e.g. malignancy) within 90 days Diagnosed significant chronic cognitive impairment (MMSE<21) Not for resuscitation order Intravenous antibiotics prior to presentation
Outcome results
None listed