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Stress Ulcer Prophylaxis in Intensive Care Unit Patients Receiving Enteral Huang et al. Critical Care (2018) 22:20 DOI 10.1186/s13054-017-1937-1 RESEARCH Open Access Stress ulcer prophylaxis in intensive care unit patients receiving enteral nutrition: a systematic review and meta-analysis Hui-Bin Huang1,2†, Wei Jiang1†, Chun-Yao Wang1, Han-Yu Qin1 and Bin Du1* Abstract Background: Pharmacologic stress ulcer prophylaxis (SUP) is recommended in critically ill patients with high risk of stress-related gastrointestinal (GI) bleeding. However, as to patients receiving enteral feeding, the preventive effect of SUP is not well-known. Therefore, we performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of pharmacologic SUP in enterally fed patients on stress-related GI bleeding and other clinical outcomes. Methods: We searched PubMed, Embase, and the Cochrane database from inception through 30 Sep 2017. Eligible trials were RCTs comparing pharmacologic SUP to either placebo or no prophylaxis in enterally fed patients in the ICU. Results were expressed as risk ratio (RR) and mean difference (MD) with accompanying 95% confidence interval (CI). Heterogeneity, subgroup analysis, sensitivity analysis and publication bias were explored. Results: Seven studies (n = 889 patients) were included. There was no statistically significant difference in GI bleeding (RR 0.80; 95% CI, 0.49 to 1.31, p = 0.37) between groups. This finding was confirmed by further subgroup analyses and sensitivity analysis. In addition, SUP had no effect on overall mortality (RR 1.21; 95% CI, 0.94 to 1.56, p =0.14),Clostridium difficile infection (RR 0.89; 95% CI, 0.25 to 3.19, p = 0.86), length of stay in the ICU (MD 0.04 days; 95% CI, −0.79 to 0.87, p = 0.92), duration of mechanical ventilation (MD −0.38 days; 95% CI, −1.48 to 0.72, p = 0.50), but was associated with an increased risk of hospital-acquired pneumonia (RR 1.53; 95% CI, 1.04 to 2.27; p =0.03). Conclusions: Our results suggested that in patients receiving enteral feeding, pharmacologic SUP is not beneficial and combined interventions may even increase the risk of nosocomial pneumonia. Keywords: Stress ulcer prophylaxis, Enteral nutrition, Critically ill, Meta-analysis Background injury or major burns, or those with ≥ 2riskfactors[5,6], Over the past decades, stress-related bleeding has become SUP is still being used in nearly 90% of ICU patients, extremely uncommon in intensive care unit (ICU) despite lack of an accepted indication in the majority [7– patients [1]. Apart from pharmacologic approaches for 9]. Furthermore, SUP is often continued in these patients stress ulcer prophylaxis (SUP), advances in the care of until clinical improvement, or even after transfer to the critically ill patients, such as optimal fluid resuscitation to general ward [1, 10]. However, SUP is not without risks. maintain hemodynamic stability and thus improve The extensive use of SUP has been demonstrated to be as- splanchnic perfusion, and early provision of enteral sociated with a higher rate of hospital-acquired nutrition (EN), may contribute to this observation [2–4]. pneumonia (HAP) due to loss of the protective bacterio- Although recommended only in patients on mechanical static effect of gastric acid [4, 11]. Meanwhile, concomi- ventilation or coagulopathy, patients with traumatic brain tant treatment of SUP and broad-spectrum antibiotics has also contributed to higher risks of Clostridium difficile * Correspondence: [email protected] infection [12, 13]. Thus, selection of potentially high-risk † Equal contributors patients who may benefit from SUP while avoiding 1Medical ICU, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, 1 Shuai Fu Yuan, Beijing unnecessary use in others is important. 100730, People’s Republic of China Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Huang et al. Critical Care (2018) 22:20 Page 2 of 9 Some earlier studies reported that EN alone might EN; (3) intervention - patients receiving any pharmaco- provide sufficient prophylaxis against stress-related logic SUP, regardless of dosage, frequency and duration; gastrointestinal (GI) bleeding [3, 14]. In animal models, (4) control - patients receiving placebo or no prophylaxis; enteral feeding is documented to increase GI blood flow (5) predefined outcomes - GI bleeding, overall mortality at and provide protection against GI bleeding [15, 16]. In a the longest available follow up, HAP, length of ICU stay, prospective, open-label trial, continuous EN was shown duration of mechanical ventilation and C. difficile more likely than proton pump inhibitors (PPIs) or hista- infection. To facilitate comparison with the previous mine 2 receptor antagonists (H2RAs) to raise gastric pH meta-analysis by Marik et al. [4], we required included to above 3.5, suggesting that EN might be more effective studies to specifically report that > 50% of enrolled in preventing GI bleeding than pharmacologic SUP [17]. patients received EN [4]. We excluded studies enrolling Although several recent systematic reviews have com- patients who were < 18 years old, using SUP due to active paratively evaluated pharmacologic agents for SUP, few bleeding or increased risk of bleeding, or receiving of these studies have specialized in patients received EN palliative care and publications available only in abstract [4, 18–20]. In 2010, one meta-analysis comparing form or meeting reports. Studies with inadequate informa- H2RAs to placebo or no prophylaxis for SUP looked into tion about enteral feeding were also excluded. We a subgroup of enterally fed patients. In this subgroup, contacted the authors if the data on predefined outcomes SUP did not decrease the risk of bleeding, and in con- from their studies were required. trast led to more episodes of hospital-acquired pneumo- nia (HAP) and higher mortality rate [4]. However, these Data extraction and quality assessment findings were based on an evaluation of only 262 pa- Two reviewers (H-BH and W J) independently extracted tients in three randomized controlled trials (RCTs) data from included studies, such as the first author, year (three trials in GI bleeding, two trials in HAP and mor- of publication, country, sample size, study design, tality), which were published between the years 1985 setting, treatment protocol for SUP and comparator, and 1994 and compared H2RAs with placebo [21–23]. severity of illness, and all predefined outcomes. Quality In addition, two out of the three RCTs were unblinded of included studies was evaluated using the risk of bias [21, 22], and some of potentially important outcomes to tool recommended by the Cochrane Collaboration [25]. clinicians or patients, including duration of mechanical We assigned a value of high, unclear, or low to the ventilation, incidence of C. difficile infection, ventilator- following items: sequence generation; allocation conceal- associated pneumonia (VAP) and length of ICU stay ment; blinding; incomplete outcome data; selective were not considered in this meta-analysis. outcome reporting; and other sources of bias. Discrepan- Therefore, in order to address these limitations, we cies were identified and resolved through discussion. sought to expand the previous meta-analysis by adding relevant RCTs published between 1994 and 2017, and Outcomes and statistical analysis including any prophylaxis regimens. We reviewed these The primary outcome was bleeding rate, which was RCTs to determine if there are differences between defined as overt GI bleeding (if reported in the enrolled pharmacologic SUP and placebo or no prophylaxis in studies) or clinically important GI bleeding (if overt GI enterally fed patients in terms of stress ulcer-related GI bleeding was not reported in the enrolled studies). bleeding, and other clinical outcomes. Secondary outcomes included incidence of HAP, overall mortality, C. difficile infection, length of ICU stay, and Methods duration of mechanical ventilation. When the outcome Search strategy and selection criteria of HAP was unavailable, the rate of VAP was used. The This systematic review and meta-analysis was conducted results from all relevant studies were merged to estimate in accordance with the PRISMA guidance [24]. We the pooled risk ratio (RR) and associated 95% confidence searched RCTs in PubMed, Embase, and the Cochrane intervals (CIs) for dichotomous outcomes. As to the database from inception to 30 Sep 2017 to identify po- continuous outcomes, mean difference (MD) and 95% tentially relevant studies. CI was estimated as the effect result. Some studies A population, intervention, comparator and outcomes reported the median as the measure of treatment effect, assessment based on question and literature search was with accompanying interquartile range (IQR). Before created (Additional file 1: S1). Our research was limited to data analysis, we estimated the mean from the median RCTs and no language restriction was applied. Reference and standard deviation (SD) from the IQR using lists of included articles and other systematic review and methods described in previous studies [26]. meta-analysis were also reviewed. We included studies Heterogeneity was tested with I2 statistics. I2 < 50% that met the following criteria: (1) design - RCTs; (2) was considered to indicate insignificant heterogeneity population - adult (≥18 years old) ICU patients receiving and a fixed-effect model was used, whereas a random- Huang et al. Critical Care (2018) 22:20 Page 3 of 9 effect model was used in cases of significant heterogen- enrolled 889 patients, were included in our final analysis eity (I2 > 50%).
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