Summary
Prehospital recognition and antibiotics for 999 patients with severe sepsis
Funder: HCRW
Background and study aims
Sepsis is a rare but serious complication of an infection. It kills between 36,000 and 64,000 people every year in the UK. Early diagnosis and treatment of sepsis has been shown to reduce the risk of death and improve health and well-being. Paramedics frequently come into contact with patients with sepsis, and are well placed to provide early diagnosis and treatment. This small study aims to find out whether paramedics can collect blood samples and give antibiotics to patients with severe sepsis. The aim is to find out whether it is feasible, safe and acceptable, so that a decision can be made about whether to proceed to a full study, which can confirm whether it is effective for patients and worthwhile for the NHS.
Who can participate?
Patients aged 18 and over, treated by participating paramedics and suspected of having severe ‘Red Flag’ sepsis
What does the study involve?
Participating paramedics receive training to assist them to recognise severe sepsis. If severe ‘Red Flag’ sepsis is suspected, paramedics randomly select a scratchcard, which informs them whether to provide enhanced care or usual care to the patient. All patients treated by the participating paramedics benefit from an enhanced level of assessment because of the additional training the paramedics receive. In addition to usual care, paramedics treating patients with enhanced care collect blood samples and give a first dose of intravenous antibiotics (into a vein) before the patient arrives at the hospital. Some of the patients are interviewed later and a focus group is held with paramedics to find out what they think about the intervention.
What are the possible benefits and risks of participating?
Participants may benefit from early antibiotic treatment. The antibiotic cefotaxime has already been confirmed to be safe and effective for the treatment of severe sepsis and is not under scrutiny in this study. Cefotaxime is widely used, generally well tolerated, and is the locally approved broad-spectrum antibiotic for the treatment of sepsis in Cardiff and Vale University Health Board. It is given to patients on admission to hospital as part of standard care. The more common side effects include diarrhoea, nausea, or abdominal discomfort, and are usually mild and temporary. Rarely observed side effects include allergic reactions, with the potential for anaphylaxis (a severe allergic reaction). Treatment of anaphylactic reactions is routine for paramedics, who have access to adrenaline and salbutamol for treating symptoms. Therefore the potential benefits of early use of cefotaxime by paramedics far outweigh the risks of an anaphylactic reaction. Participants who agree to follow up at 90 days may feel inconvenienced or experience a sense of intrusion when contacted. Before beginning the questionnaire process, participants are asked whether it is a convenient time for them and if not, an alternative time and date is arranged. Follow-up contact in the form of face-to-face meetings, postal correspondence and telephone calls is conducted in a friendly, courteous and timely manner.
Where is the study run from?
University Hospital Wales (UK)
When is the study starting and how long is it expected to run for?
March 2017 to February 2019
Contact Details
Trial Manager / Lead Contact: Dr Jenna Bulger
Email: j.bulger@swansea.ac.uk
ISCRTN Number: 36856873 ; IRAS ID: 213623;