SuDDICU SBK V3.1_UK 13.05.2019
Research type
Research Study
Full title
A crossover, cluster randomised controlled trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit patients
IRAS ID
227201
Contact name
Anthony C Gordon
Contact email
Sponsor organisation
Sunnybrook Health Sciences Centre
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ACTRN12615000411549, Australian New Zeland clinical Trials Registry Number
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
Sepsis is the most common cause of death in critically ill patients, with a quarter of those who develop severe sepsis dying during their hospitalisation. Even though the outcomes of patients with severe sepsis have improved the number of patients with sepsis has increased. Currently there is no effective treatment for severe sepsis other than prompt administration of fluids, antibiotics and supportive care. Many patients are admitted to hospital with severe sepsis but others develop sepsis while in the hospital. These hospital acquired infections are recognised as an increasing public health problem causing more than one million deaths worldwide.\n\nThe Selective Decontamination of the Digestive tract (SDD) is an infection control strategy designed to reduce mortality by preventing hospital acquired infection and therefore sepsis. SDD alters the balance of potentially harmful and normal bacteria in the patients mouth and stomach. This is done by applying a paste to the mouth and a liquid to the stomach in combination with a short course of antibiotics, in addition to strict hand hygiene and other infection control measures.\n\nIn this study we plan to undertake a crossover, cluster randomised trial in a number of intensive care units (ICU) using two 12-month interventional trial periods separated by a 3-month inter-period gap. We will be investigating whether SDD when added to standard care can reduce rates of infection and reduce mortality in critically ill patients in ICU.\nRunning in parallel to this RCT, we will be undertaking a process evaluation to study the impact of the SDD regime on patient outcomes in the ICU.[COVID-19 amendment – 16/03/2020] We are beginning to see more COVID-19 patients in our intensive care units and they are eligible for the trial. As a cluster randomised trial it is important for the integrity of the trial to include all patients if they are eligible. As you know for this study we already have deferred consent in place to start the treatment quickly, as patients are incapacitated at the time of eligibility. Due to the current infection risk, families are not being allowed into the ICUs as they will usually have to self-isolate. We are therefore not able to seek our normal personal consultee consent. We would therefore propose to default to nominated consultee consent in the first instance.\n \nOnce the participants have regained capacity we would then seek retrospective consent. We would need to wait for the participants to be non-infectious to ensure the safety of our clinical research staff, as well as the limit the use of PPE used on the ward (stocks are likely to be hugely limited). This may however mean that participants could be discharged from the hospital prior to us gaining consent, but in the event of this happening this would be documented appropriately.\n \nWe feel that this is the only safe and pragmatic way of gaining consent for patients being enrolled into this study and we feel that this change in process, in light of the pandemic situation, is covered by our current ethical approval.\nThere will be no change to current documentation, only to the consent process during this situation.\n\n[COVID-19 amendment – 17/03/2020]\n\nMinor changes and clarifications have been made to the listed information sheets. Feedback was provided from the research nurses, the patients and their personal consultees indicating that the section titled ‘’ what if something goes wrong’’ led to unnecessary concern especially during the ecology and control phase of the SuDDICU study, as no intervention is being provided and there is no change in normal standard of care. As a result of this direct feedback from nurses and participants we have softened the wording as approved over the phone by HRA Approvals specialist Katherine Ashley and removed what we feel is unnecessary burdensome information. \n\n
REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/0216
Date of REC Opinion
23 May 2019
REC opinion
Further Information Favourable Opinion