anaesthetic & critical care studies summaries

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Protocol v4.0 12/03/2024
Rotherham Principal Investigator: Dr Susie Robinson
Research team members: Cheryl Graham/Dr Katie Webb

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research topic:

Antibiotic duration for critically ill patients with suspected or confirmed sepsis

trial groups:

Intervention: 5 day course of initial antibiotic treatment for sepsis
Control: Standard of care

inclusion criteria:

Sepsis is defined as new or worsening organ dysfunction resulting from a suspected or proven infection. Patients admitted to critical care for support or monitoring of an organ dysfunction (e.g. invasive blood pressure monitoring or oxygen therapy), while treated for a suspected infection, are the population of interest.

​Patients must fulfil all of the following inclusion criteria prior to randomisation:

• Adult patients, aged ≥ 18, treated within a critical care setting (ICU or HDU) for suspected or confirmed sepsis due to either community- or hospital-acquired infections
• Evidence of new or worsening acute organ dysfunction resulting from suspected or confirmed infection (e.g. the treatment or monitoring of an organ dysfunction)
• Antibiotics initiated for suspected or confirmed sepsis and able to be randomised within 4 days of the initiation of this course of antibiotics.

exclusion criteria:

Patients must not meet any of the following exclusion criteria to be randomised:

• Comorbidity with immunosuppression (e.g. Chemotherapy, maintenance steroids equivalent to >10mg/day of prednisolone, post-transplantation)
• Blood neutrophil count less than 0.5 x 109 /L secondary to a pre-existing comorbidity
• Infection source where usual practice involves more than 14 days of antibiotics (e.g. undrainable abscess, endocarditis, Staphylococcus aureus bacteraemia, osteomyelitis)
• Receiving end-of-life care
• Life-sustaining treatment expected to be withdrawn within the next 24 hours
• The clinician responsible for the patient’s care is unable to adhere to the intervention

consent:

Formal consent is required for SHORTER trial enrolment/randomisation. If you think your patient is in any way eligible please contact the research team who will review the full inclusion/exclusion criteria and approach for consent.