Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)
Critical Illness, Sepsis, Septic Shock
About this trial
This is an interventional prevention trial for Critical Illness
Eligibility Criteria
Inclusion Criteria:
Site inclusion for cluster study- A general ICU or complex of ICUs (medical, surgical, mixed) capable of treating mechanically ventilated critically ill adult patients.
Patient inclusion criteria
- All patients who are mechanically ventilated via an endotracheal tube on admission to ICU and who are predicted to remain ventilated beyond the end of the calendar day after the day of ICU admission, or
- All patients who become mechanically ventilated via an endotracheal tube during their ICU stay and who are predicted to remain ventilated beyond the end of the calendar day after the day they are first ventilated, or
- All patients not already recruited who are receiving mechanical ventilation via an endotracheal tube and are expected to receive ongoing ventilation for a further 48 hours or more despite an earlier prediction that ventilation would be discontinued earlier.
Site exclusion criteria for cluster study-
- Unwilling or unable to follow trial protocols.
- Unable to capture the minimum data set required for the study.
- Isolated specialty ICUs not co-located with a general ICU, such as solely cardiac, neurological/neurosurgical and burns ICUs, but such specialty patients cared for in general ICUs will be included
- Specialty paediatric ICUs
Exclusion Criteria:
Patient exclusion criteria
- Patients enrolled in a trial that would interact with the intervention
- Patients with a known allergy, sensitivity or interaction to trial topical intervention drugs
- Patients who are known or suspected to be pregnant
- Patients who are moribund and not expected to survive the next 12 hours
- Patients less than 16 years of age will not be enrolled in the UK
Sites / Locations
- The George Institute for Global Health
- Sunnybrook Health Sciences Centre
- Imperial College London
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control group- standard care
SDD intervention group
Standard care- In Australia there are no national guidelines so local policy is determined by each ICU. We are recommending (but not mandating) that control and SDD group management be in line with these national guidelines. We will recommend control and SDD group management is in line with current national standards of practice that may or may not include a VAP bundle. We will monitor record data regarding the nature and delivery of the control and SDD group co-interventions.
The intervention will entail: A six-hourly topical application of 0.5g paste, containing colistin 10mg, tobramycin 10mg and nystatin 125,000 IU, to the buccal mucosa and oropharynx A six-hourly administration of 10 mL of a suspension containing 100 mg colistin, 80 mg tobramycin and 2 x 10^6 IU nystatin, to the gastrointestinal tract via a gastric/post-pyloric tube A four-day course of an IV antibiotic. Patients not already receiving a therapeutic antibiotic will be prescribed cefotaxime 1g six-hourly or ceftriaxone 1g daily, with dose adjusted as appropriate for organ dysfunction. Ciprofloxacin (400mg 12-hourly) may be used as an alternative if there is a contraindication to cephalosporins (e.g. allergy). Patients already receiving an alternative IV antibiotic to treat infection will not receive this additional IV antibiotic, but will continue the prescribed antibiotic for the usual duration of therapy.