Sepsis Clinical Trial
— SuDDICUOfficial title:
A Crossover, Cluster Randomised Controlled Trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)
Verified date | August 2023 |
Source | The George Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction- Hospital acquired infections (HAI) are a major cause of morbidity and mortality and increase health care costs. Critically ill patients are particularly susceptible to these infections and have an even higher mortality. One intervention that has gained much interest in the medical literature for reducing infection rates and deaths from HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of antibiotic paste to the mouth, throat, stomach and a short course of intravenous antibiotics. The evidence supporting the use of SDD for saving lives and preventing infections is actually quite strong. However, health care professionals in many parts of the world have refrained from using SDD due to fears of the effects of overuse of antibiotics on the frequency of infections with resistant bacteria such as multi-resistant Gram negative organisms, MRSA and Clostridium difficile. SuDDICU is a cross-over, cluster randomised trial comparing the effect of using selective decontamination of the digestive tract (SDD) plus standard care, to standard care alone on hospital mortality in patients receiving mechanical ventilation in the intensive care unit (ICU). Secondary outcomes include an ecological assessment and a long-term health economic analysis.
Status | Completed |
Enrollment | 20010 |
Est. completion date | April 26, 2023 |
Est. primary completion date | April 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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 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 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 4. Specialty paediatric ICUs Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Australia | The George Institute for Global Health | Sydney | New South Wales |
Canada | Sunnybrook Health Sciences Centre | Toronto | |
United Kingdom | Imperial College London | London |
Lead Sponsor | Collaborator |
---|---|
The George Institute | Imperial College London, Sunnybrook Health Sciences Centre |
Australia, Canada, United Kingdom,
Cuthbertson BH, Campbell MK, MacLennan G, Duncan EM, Marshall AP, Wells EC, Prior ME, Todd L, Rose L, Seppelt IM, Bellingan G, Francis JJ. Clinical stakeholders' opinions on the use of selective decontamination of the digestive tract in critically ill pat — View Citation
Cuthbertson BH, Francis J, Campbell MK, MacIntyre L, Seppelt I, Grimshaw J; SuDDICU study groups. A study of the perceived risks, benefits and barriers to the use of SDD in adult critical care units (the SuDDICU study). Trials. 2010 Dec 3;11:117. doi: 10. — View Citation
Daneman N, Sarwar S, Fowler RA, Cuthbertson BH; SuDDICU Canadian Study Group. Effect of selective decontamination on antimicrobial resistance in intensive care units: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Apr;13(4):328-41. doi: 10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital Mortality | all-cause mortality at time of hospital discharge | Hospital discharge [up to Day 90 after randomization] | |
Secondary | Total antibiotic usage | Total antibiotic usage (as daily defined doses) during ICU admission in all ICU admissions. | during ICU admission | |
Secondary | The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites | The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites during ICU admission in all ICU admissions. | during ICU admission | |
Secondary | The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens | The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens during ICU admission in all ICU admissions | during ICU admission | |
Secondary | The incidence of C. difficile infections | The incidence of C. difficile infections during ICU admission in all ICU admissions | during ICU admission | |
Secondary | Changes in antibiotic resistance rates between study epochs (pre-trial, interperiod gap and post-trial) within groups | Changes in ARO rates between time epochs (pre-trial, trial, inter-period gap and post-trial) within groups. With control group data to give the secular trend in ARO with time and SDD group data studying the effects of SDD withdrawal from practice in the year after SDD delivery | Through out all study periods | |
Secondary | Duration of mechanical ventilation | Duration that the patient is mechanically ventilated in the ICU | Time of enrolment to ICU discharge within index hospital admission,[up to Day 90 after randomization] | |
Secondary | ICU length of stay | The length of time a patient stays in the ICU | From the time of enrolment to ICU discharge, [up to Day 90 after randomization] | |
Secondary | Hospital length of stay | The total hospital length of stay for patient | From time of enrolment to hospital discharge within the index hospital admission, [up to Day 90 after randomization] | |
Secondary | ICU Mortality | mortality at time of ICU discharge | ICU discharge [up to Day 90 after randomization] |
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