The QUEST Study (version 1)
Research type
Research Study
Full title
The QUEST Study: Quantifying the Economic Impact on Sepsis Patient Care Pathway by Point-of-Care Testing
IRAS ID
127451
Contact name
David Kirby
Contact email
Research summary
Sepsis, severe sepsis and septic shock carry an unacceptable high mortality, amounting to around 1,400 deaths worldwide every day. Sepsis also has a substantial burden on healthcare resources and accounts for almost 40% of Intensive Care Unit costs in Europe . Early, goal-directed therapy has been demonstrated to provide significant benefits with respect to outcome in patients with severe sepsis and septic shock . There have been a number of recent developments in the management of sepsis. One example is the introduction of a Severe Sepsis Screening Tool, which applies a set of easy to measure physiological parameters at an early stage and on a regular basis to compromised patients1. \n\nPatients with abnormal physiology (including any two systemic inflammatory response syndrome (SIRS) criteria of: increased heart rate, fever, increased breathing rate, confusion or high blood sugar) and evidence of a new infection are said to suffer from ‘Sepsis’. When this abnormal physiology is coupled with evidence of organ failure (such as: low blood pressure; reduced urine output abnormal clotting; new oxygen requirement) the patient has ‘Severe Sepsis’. The mortality rate of severe sepsis approaches 40% of patients. \n\nThe current Sepsis Care Pathway consists of a two phased approach of intervention packages (bundles) for: (1) Resuscitation and (2) Management. In the Emergency Department, as soon as a patient is identified as “triggering” the criteria for sepsis, the Resuscitation bundle is delivered. The resuscitation bundle consists of: measurement of lactate, urine output and blood cultures; the provision of supplemental oxygen; administration of aggressive intravenous fluid therapy and antibiotics. It is anticipated that by delivering the resuscitation and management bundles each and every time to eligible patients, mortality can be reduced by up to 25%. However, it is apparent that there will be a degree of overprovision of this aggressive approach to therapy and some cases where perhaps it was not needed at all or prolonged continuation of antibiotic therapy is beyond that which is truly required. \n\nPoint of care tests (POCTs) can be used in the sepsis care pathway and the procalcitonin test is such an example. The procalcitonin POCT has been suggested as a potential addition to the sepsis care pathway . The procalcitonin POCT could potentially be used to indicate: (a) whether the sepsis care pathway is appropriate; (b) whether to stop antibiotics and (c) when to stop antibiotics. Procalcitonin is a precursor of calcitonin which under normal circumstances is produced by the C-cells of the thyroid and certain endocrine cells of the lung. Serum concentrations of procalcitonin are normally <0.1 ng/ml but in circumstances of systemic inflammation, particularly bacterial infection, it is produced in large quantities by many body tissues. Procalcitonin, which is detectable within 2-4 hours and peaks within 6-24 hours, is not impaired by neutropenia or other immunosuppressive states. Importantly, the procalcitonin level will parallel the severity of the inflammatory response. \n\nThe overall aim of the project is to develop an economic model to understand the expected costs and outcomes associated with introducing a point-of-care (POC) diagnostic test into the management of patients presenting with sepsis. This is primarily a methodological project that focuses on the feasibility of using an economic model to predict the cost effectiveness of a POC test in the emergency department. There will be academic publication outputs, but the primary intended output is an economic model that will be a functional decision-making tool to assess the impact of POC testing in sepsis. \n
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0238
Date of REC Opinion
21 Jun 2013
REC opinion
Favourable Opinion