Effect of Probiotics on Incident Ventilator-Associated Pneumonia in Critically Ill Patients A Randomized Clinical Trial
Por:
Johnstone, J, Meade, M, Lauzier, F, Marshall, J, Duan, E, Dionne, J, Arabi, YM, Heels-Ansdell, D, Thabane, L, Lamarche, D, Surette, M, Zytaruk, N, Mehta, S, Dodek, P, McIntyre, L, English, S, Rochwerg, B, Karachi, T, Henderson, W, Wood, G, Ovakim, D, Herridge, M, Granton, J, Wilcox, ME, Goffi, A, Stelfox, HT, Niven, D, Muscedere, J, Lamontagne, F, D'Aragon, F, St-Arnaud, C, Ball, I, Nagpal, D, Girard, M, Aslanian, P, Charbonney, E, Williamson, D, Sligl, W, Friedrich, J, Adhikari, NK, Marquis, F, Archambault, P, Khwaja, K, Kristof, A, Kutsogiannis, J, Zarychanski, R, Paunovic, B, Reeve, B, Lellouche, F, Hosek, P, Tsang, J, Binnie, A, Trop, S, Loubani, O, Hall, R, Cirone, R, Reynolds, S, Lysecki, P, Golan, E, Cartin-Ceba, R, Taylor, R, Cook, D, Mancebo J., Gramish, Jawaher A.
Publicada:
21 sep 2021
Resumen:
Question Does the probiotic Lactobacillus rhamnosus GG prevent ventilator-associated pneumonia (VAP) among critically ill patients? Findings In this randomized trial involving 2650 patients, no significant difference in VAP incidence was found among patients treated with probiotics compared with placebo (21.9% vs 21.3%, respectively; hazard ratio 1.03; 95% CI 0.87-1.22). Meaning These findings do not support the use of Lactobacillus rhamnosus GG for prevention of ventilator-associated pneumonia in critically ill patients requiring mechanical ventilation.
Importance Growing interest in microbial dysbiosis during critical illness has raised questions about the therapeutic potential of microbiome modification with probiotics. Prior randomized trials in this population suggest that probiotics reduce infection, particularly ventilator-associated pneumonia (VAP), although probiotic-associated infections have also been reported. Objective To evaluate the effect of Lactobacillus rhamnosus GG on preventing VAP, additional infections, and other clinically important outcomes in the intensive care unit (ICU). Design, Setting, and Participants Randomized placebo-controlled trial in 44 ICUs in Canada, the United States, and Saudi Arabia enrolling adults predicted to require mechanical ventilation for at least 72 hours. A total of 2653 patients were enrolled from October 2013 to March 2019 (final follow-up, October 2020). Interventions Enteral L rhamnosus GG (1 x 10(10) colony-forming units) (n = 1321) or placebo (n = 1332) twice daily in the ICU. Main Outcomes and Measures The primary outcome was VAP determined by duplicate blinded central adjudication. Secondary outcomes were other ICU-acquired infections including Clostridioides difficile infection, diarrhea, antimicrobial use, ICU and hospital length of stay, and mortality. Results Among 2653 randomized patients (mean age, 59.8 years [SD], 16.5 years), 2650 (99.9%) completed the trial (mean age, 59.8 years [SD], 16.5 years; 1063 women [40.1%.] with a mean Acute Physiology and Chronic Health Evaluation II score of 22.0 (SD, 7.8) and received the study product for a median of 9 days (IQR, 5-15 days). VAP developed among 289 of 1318 patients (21.9%) receiving probiotics vs 284 of 1332 controls (21.3%; hazard ratio [HR], 1.03 (95% CI, 0.87-1.22; P = .73, absolute difference, 0.6%, 95% CI, -2.5% to 3.7%). None of the 20 prespecified secondary outcomes, including other ICU-acquired infections, diarrhea, antimicrobial use, mortality, or length of stay showed a significant difference. Fifteen patients (1.1%) receiving probiotics vs 1 (0.1%) in the control group experienced the adverse event of L rhamnosus in a sterile site or the sole or predominant organism in a nonsterile site (odds ratio, 14.02; 95% CI, 1.79-109.58; P < .001). Conclusions and Relevance Among critically ill patients requiring mechanical ventilation, administration of the probiotic L rhamnosus GG compared with placebo, resulted in no significant difference in the development of ventilator-associated pneumonia. These findings do not support the use of L rhamnosus GG in critically ill patients.
This clinical trial assessed whether Lactobacillus rhamnosus GG compared with placebo reduces ventilator-associated pneumonia and other clinically important outcomes for a broad range of critically ill patients.
Filiaciones:
Johnstone, J:
Univ Toronto, Toronto, ON, Canada
Meade, M:
McMaster Univ, Hamilton, ON, Canada
Lauzier, F:
Univ Laval, Quebec City, PQ, Canada
Marshall, J:
Univ Toronto, Toronto, ON, Canada
Duan, E:
McMaster Univ, Hamilton, ON, Canada
Dionne, J:
McMaster Univ, Hamilton, ON, Canada
Arabi, YM:
King Saud Bin Abdulaziz Univ Hlth Sci, Riyadh, Saudi Arabia
Heels-Ansdell, D:
McMaster Univ, Hamilton, ON, Canada
Thabane, L:
McMaster Univ, Hamilton, ON, Canada
Lamarche, D:
McMaster Univ, Hamilton, ON, Canada
Surette, M:
McMaster Univ, Hamilton, ON, Canada
Zytaruk, N:
McMaster Univ, Hamilton, ON, Canada
Mehta, S:
Univ Toronto, Toronto, ON, Canada
Dodek, P:
Univ British Columbia, Vancouver, BC, Canada
McIntyre, L:
Univ Ottawa, Ottawa, ON, Canada
English, S:
Univ Ottawa, Ottawa, ON, Canada
Rochwerg, B:
McMaster Univ, Hamilton, ON, Canada
Karachi, T:
McMaster Univ, Hamilton, ON, Canada
Henderson, W:
Univ British Columbia, Vancouver, BC, Canada
Wood, G:
Univ Victoria, Victoria, BC, Canada
Ovakim, D:
Univ Victoria, Victoria, BC, Canada
Herridge, M:
Univ Toronto, Toronto, ON, Canada
Granton, J:
Univ Toronto, Toronto, ON, Canada
Wilcox, ME:
Univ Toronto, Toronto, ON, Canada
Goffi, A:
Univ Toronto, Toronto, ON, Canada
Stelfox, HT:
Univ Calgary, Calgary, AB, Canada
Niven, D:
Univ Calgary, Calgary, AB, Canada
Muscedere, J:
Queens Univ, Kingston, ON, Canada
Lamontagne, F:
Univ Sherbrooke, Sherbrooke, PQ, Canada
D'Aragon, F:
Univ Sherbrooke, Sherbrooke, PQ, Canada
St-Arnaud, C:
Univ Sherbrooke, Sherbrooke, PQ, Canada
Ball, I:
Western Univ, London, ON, Canada
Nagpal, D:
Western Univ, London, ON, Canada
Girard, M:
Univ Montreal, Montreal, PQ, Canada
Aslanian, P:
Univ Montreal, Montreal, PQ, Canada
Charbonney, E:
Univ Montreal, Montreal, PQ, Canada
Williamson, D:
Univ Montreal, Montreal, PQ, Canada
Sligl, W:
Univ Alberta, Edmonton, AB, Canada
Friedrich, J:
Univ Toronto, Toronto, ON, Canada
Adhikari, NK:
Univ Toronto, Toronto, ON, Canada
Marquis, F:
Univ Montreal, Montreal, PQ, Canada
Archambault, P:
Univ Laval, Quebec City, PQ, Canada
Khwaja, K:
McGill Univ, Montreal, PQ, Canada
Kristof, A:
McGill Univ, Montreal, PQ, Canada
Kutsogiannis, J:
Univ Alberta, Edmonton, AB, Canada
Zarychanski, R:
Univ Manitoba, Winnipeg, MB, Canada
Paunovic, B:
Univ Manitoba, Winnipeg, MB, Canada
Reeve, B:
McMaster Univ, Hamilton, ON, Canada
Lellouche, F:
Univ Laval, Quebec City, PQ, Canada
Hosek, P:
McMaster Univ, Hamilton, ON, Canada
Tsang, J:
McMaster Univ, Hamilton, ON, Canada
Binnie, A:
Univ Toronto, Toronto, ON, Canada
Trop, S:
Univ Montreal, Montreal, PQ, Canada
Loubani, O:
Dalhousie Univ, Halifax, NS, Canada
Hall, R:
Dalhousie Univ, Halifax, NS, Canada
Cirone, R:
Univ Toronto, Toronto, ON, Canada
Reynolds, S:
Univ British Columbia, Vancouver, BC, Canada
Lysecki, P:
McMaster Univ, Hamilton, ON, Canada
Golan, E:
Univ Toronto, Toronto, ON, Canada
Cartin-Ceba, R:
Mayo Clin, Rochester, MN USA
Taylor, R:
Mercy Hosp, St Louis, MO USA
Cook, D:
McMaster Univ, Hamilton, ON, Canada
Mancebo J.:
Institut d’Investigació Biomèdica Sant Pau (IIB SANT PAU), Sant Quintí 77-79, 08041 Barcelona, Spain
Gramish, Jawaher A.:
King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia
Bronze, Green Published
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