A crossover, cluster randomised controlled trial of selective decontamination of the digestive tract in intensive care patients (SuDDICU)

The George Institute for Global Health0 个研究点目标入组 15,000 人开始时间: 2015年4月30日最近更新: 2022年4月4日

试验速览

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•Site inclusion for cluster study:
•A general ICU or complex of ICUs (medical, surgical, mixed) capable of treating mechanically ventilated critically ill patients.
•Patient Inclusion Criteria:
•1. 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
•2. 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
•3. 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:
•1.Unwilling or unable to follow trial protocols.
•2.Unable to capture the minimum data set required for the study.
•3.Isolated specialty ICUs (non 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).
•4. Specialty paediatric ICUs
•Patient exclusion criteria:
•1. Patients enrolled in a trial that would interact with the intervention
•2. Patients with a known allergy, sensitivity or interaction to trial topical intervention drugs
•3. Patients who are known or suspected to be pregnant
•4. Patients who are moribund and not expected to survive the next 12 hours
•5. Patients less than 16 years of age will not be enrolled in the UK
•Patients readmitted to the ICU will be re-enrolled into the study and receive study interventions if they meet inclusion criteria and do not have any exclusion criteria. They will be counted as the same enrolment for study analysis.

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