Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial

被引：43

作者：

Cook, Deborah J. ^{[1
,2
]}

Johnstone, Jennie ^{[3
,4
,5
]}

Marshall, John C. ^{[6
,7
]}

Lauzier, Francois ^{[8
,9
,10
]}

Thabane, Lehana ^{[2
]}

Mehta, Sangeeta ^{[5
,7
]}

Dodek, Peter M. ^{[11
,12
,13
]}

McIntyre, Lauralyn ^{[14
]}

Pagliarello, Joe ^{[14
]}

Henderson, William ^{[15
]}

Taylor, Robert W. ^{[16
]}

Cartin-Ceba, Rodrigo ^{[17
]}

Golan, Eyal ^{[5
,7
]}

Herridge, Margaret ^{[5
,7
]}

Wood, Gordon ^{[18
]}

Ovakim, Daniel ^{[18
]}

Karachi, Tim ^{[1
]}

Surette, Michael G. ^{[1
]}

Bowdish, Dawn M. E. ^{[19
]}

Lamarche, Daphnee ^{[20
]}

Verschoor, Chris P. ^{[19
]}

Duan, Erick H. ^{[1
]}

Heels-Ansdell, Diane ^{[2
]}

Arabi, Yaseen ^{[21
,22
]}

Meade, Maureen ^{[1
,2
]}

机构：

[1] McMaster Univ, McMaster Hlth Sci Ctr, Dept Med, Room 2C11,1200 Main St W, Hamilton, ON, Canada

[2] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada

[3] Publ Hlth Ontario, Toronto, ON, Canada

[4] St Josephs Hlth Ctr, Toronto, ON, Canada

[5] Univ Toronto, Dept Med, Toronto, ON, Canada

[6] Univ Toronto, Dept Surg, Toronto, ON, Canada

[7] Univ Toronto, Interdept Div Crit Care, Toronto, ON, Canada

[8] Univ Laval, Populat Hlth & Optimal Hlth Practices Res Unit, CHU Quebec, Res Ctr, Quebec City, PQ, Canada

[9] Univ Laval, Dept Med, Quebec City, PQ, Canada

[10] Univ Laval, Dept Anesthesiol & Crit Care, Quebec City, PQ, Canada

[11] St Pauls Hosp, Div Crit Care Med, Vancouver, BC, Canada

[12] Univ British Columbia, Vancouver, BC, Canada

[13] St Pauls Hosp, Ctr Hlth Evaluat & Outcome Sci, Vancouver, BC, Canada

[14] Univ Ottawa, Div Crit Care, Ottawa, ON, Canada

[15] Vancouver Gen Hosp, Div Crit Care Med, Vancouver, BC, Canada

[16] Mercy Hosp, Dept Crit Care Med, St Louis, MO USA

[17] Mayo Clin, Div Pulm & Crit Care Med, Rochester, MN USA

[18] Vancouver Isl Hlth Author, Dept Anesthesia Crit Care, Victoria, BC, Canada

[19] McMaster Univ, Dept Pathol & Mol Med, Hamilton, ON, Canada

[20] McMaster Univ, Biochem & Biomed Sci Dept, Hamilton, ON, Canada

[21] King Saud Bin Abdulaziz Univ Hlth Sci, Riyadh, Saudi Arabia

[22] King Abdullah Int Med Res Ctr, Riyadh, Saudi Arabia

来源：

TRIALS | 2016年 / 17卷

基金：

加拿大健康研究院;

关键词：

Critically ill; Infection; Intensive care; Probiotics; VENTILATOR-ASSOCIATED PNEUMONIA; CLINICAL-PRACTICE GUIDELINES; INFECTION; DIARRHEA;

D O I：

10.1186/s13063-016-1495-x

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). Methods: In a randomized blinded trial, patients expected to be mechanically ventilated for >= 72 hours were allocated to receive either 1 x 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate >= 10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Results: Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. Conclusions: The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients.

引用

页数：10

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