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Boschert, Catherine; Broadfield, Emma; Chimunda, Timothy; Fletcher, Jason; Knott, Cameron; Porwal, Sanjay; Smith, Julie; Bhonagiri, Deepak; Leijten, Monique; Narayan, Sandhya; Sanchez, David; Saunders, Peta; Sherriff, Carli; Barrett, Jonathan; Hanlon, Gabrielle; Jelly-Butterworth, Sarah; O'Donnell, Julie; Watson, Judith; Bihari, Shailesh; Brown, Julia; Comerford, Sharon; Laver, Russell; McIntyre, JoAnne; Shrestha, Tapaswi; [...]

Effect of Selective Decontamination of the Digestive Tract on Hospital Mortality in Critically Ill Patients Receiving Mechanical Ventilation : A Randomized Clinical Trial

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  • Media type: E-Article
  • Title: Effect of Selective Decontamination of the Digestive Tract on Hospital Mortality in Critically Ill Patients Receiving Mechanical Ventilation : A Randomized Clinical Trial : A Randomized Clinical Trial
  • Contributor: Boschert, Catherine; Broadfield, Emma; Chimunda, Timothy; Fletcher, Jason; Knott, Cameron; Porwal, Sanjay; Smith, Julie; Bhonagiri, Deepak; Leijten, Monique; Narayan, Sandhya; Sanchez, David; Saunders, Peta; Sherriff, Carli; Barrett, Jonathan; Hanlon, Gabrielle; Jelly-Butterworth, Sarah; O'Donnell, Julie; Watson, Judith; Bihari, Shailesh; Brown, Julia; Comerford, Sharon; Laver, Russell; McIntyre, JoAnne; Shrestha, Tapaswi; [...]
  • Published: American Medical Association (AMA), 2022
  • Published in: JAMA, 328 (2022) 19, Seite 1911
  • Language: English
  • DOI: 10.1001/jama.2022.17927
  • ISSN: 0098-7484
  • Origination:
  • Footnote:
  • Description: <jats:sec><jats:title>Importance</jats:title><jats:p>Whether selective decontamination of the digestive tract (SDD) reduces mortality in critically ill patients remains uncertain.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To determine whether SDD reduces in-hospital mortality in critically ill adults.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>A cluster, crossover, randomized clinical trial that recruited 5982 mechanically ventilated adults from 19 intensive care units (ICUs) in Australia between April 2018 and May 2021 (final follow-up, August 2021). A contemporaneous ecological assessment recruited 8599 patients from participating ICUs between May 2017 and August 2021.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>ICUs were randomly assigned to adopt or not adopt a SDD strategy for 2 alternating 12-month periods, separated by a 3-month interperiod gap. Patients in the SDD group (n = 2791) received a 6-hourly application of an oral paste and administration of a gastric suspension containing colistin, tobramycin, and nystatin for the duration of mechanical ventilation, plus a 4-day course of an intravenous antibiotic with a suitable antimicrobial spectrum. Patients in the control group (n = 3191) received standard care.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>The primary outcome was in-hospital mortality within 90 days. There were 8 secondary outcomes, including the proportion of patients with new positive blood cultures, antibiotic-resistant organisms (AROs), and <jats:italic>Clostridioides difficile</jats:italic> infections. For the ecological assessment, a noninferiority margin of 2% was prespecified for 3 outcomes including new cultures of AROs.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 5982 patients (mean age, 58.3 years; 36.8% women) enrolled from 19 ICUs, all patients completed the trial. There were 753/2791 (27.0%) and 928/3191 (29.1%) in-hospital deaths in the SDD and standard care groups, respectively (mean difference, −1.7% [95% CI, −4.8% to 1.3%]; odds ratio, 0.91 [95% CI, 0.82-1.02]; <jats:italic>P</jats:italic> = .12). Of 8 prespecified secondary outcomes, 6 showed no significant differences. In the SDD vs standard care groups, 23.1% vs 34.6% had new ARO cultures (absolute difference, −11.0%; 95% CI, −14.7% to −7.3%), 5.6% vs 8.1% had new positive blood cultures (absolute difference, −1.95%; 95% CI, −3.5% to −0.4%), and 0.5% vs 0.9% had new <jats:italic>C difficile</jats:italic> infections (absolute difference, −0.24%; 95% CI, −0.6% to 0.1%). In 8599 patients enrolled in the ecological assessment, use of SDD was not shown to be noninferior with regard to the change in the proportion of patients who developed new AROs (−3.3% vs −1.59%; mean difference, −1.71% [1-sided 97.5% CI, −∞ to 4.31%] and 0.88% vs 0.55%; mean difference, −0.32% [1-sided 97.5% CI, −∞ to 5.47%]) in the first and second periods, respectively.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>Among critically ill patients receiving mechanical ventilation, SDD, compared with standard care without SDD, did not significantly reduce in-hospital mortality. However, the confidence interval around the effect estimate includes a clinically important benefit.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02389036">NCT02389036</jats:ext-link></jats:p></jats:sec>