Dataset Information

Need for a Randomized Controlled Trial of Stress Ulcer Prophylaxis in Critically Ill Children: A Canadian Survey.

ABSTRACT:

Background

Stress ulcer prophylaxis is commonly used in pediatric critical care, to prevent upper gastrointestinal bleeding. The most frequently used agents are histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). The risk-benefit ratio for stress ulcer prophylaxis is uncertain, because data from randomized clinical trials (RCTs) on the effectiveness and harms of prophylaxis in children are limited.

Objective

To describe the views of Canadian pediatric intensivists about a future RCT of stress ulcer prophylaxis.

Methods

We conducted an online survey of Canadian pediatric critical care physicians. We e-mailed information about the study and a link to a 10-item survey to 111 potential respondents, with 2 reminders for nonrespondents. We assessed the relationship between respondents' characteristics and their views about the need for and potential participation in a trial using logistic regression and assessed regional differences using the ?² test.

Results

The 68 physicians who replied (61% of potential respondents) had a median of 12 (interquartile range 5-20) years of experience. Forty-four (65%) of the respondents stated that a large, rigorous RCT of stress ulcer prophylaxis in children is needed, and 94% (62 of 66) indicated that it should include a placebo group. The 3 most common designs suggested were a 3-arm trial comparing PPI, H2RA, and placebo (56% [37 of 66 respondents to this question]) and 2-arm trials comparing PPI with placebo (15% [n = 10]) and H2RA with placebo (8% [n = 5]). The 5 patient groups that respondents most commonly stated should be excluded (because they should not receive placebo) were children receiving acid suppression at home (66% [42 of 64 respondents to this question]) or corticosteroids (59% [n = 38]), those with severe coagulopathy or receiving extracorporeal membrane oxygenation (both 36% [n = 23]), and those with burns (31% [n = 20]). Most respondents indicated a willingness to participate in an RCT (64% [42 of 66 respondents to this question]), whereas some (29% [n = 19]) indicated that participation would depend on trial design or funding; only 8% (n = 5) were disinclined to participate.

Conclusions

There is considerable interest in a placebo-controlled RCT of stress ulcer prophylaxis among pediatric critical care physicians in Canada, but consensus on key elements of the trial design is needed.

SUBMITTER: Duffett M

PROVIDER: S-EPMC5587042 | biostudies-literature | 2017 Jul-Aug

REPOSITORIES: biostudies-literature

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Publications

Need for a Randomized Controlled Trial of Stress Ulcer Prophylaxis in Critically Ill Children: A Canadian Survey.

Duffett Mark M Choong Karen K Foster Jennifer J Gilfoyle Elaine E Lacroix Jacques J Cook Deborah J DJ

The Canadian journal of hospital pharmacy 20170701 4

<h4>Background</h4>Stress ulcer prophylaxis is commonly used in pediatric critical care, to prevent upper gastrointestinal bleeding. The most frequently used agents are histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). The risk-benefit ratio for stress ulcer prophylaxis is uncertain, because data from randomized clinical trials (RCTs) on the effectiveness and harms of prophylaxis in children are limited.<h4>Objective</h4>To describe the views of Canadian pediatric inten ...[more]

PMID: 28894313

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Project description:PurposeStress ulcer prophylaxis (SUP) is commonly prescribed in the intensive care unit. However, data from systematic reviews and conventional meta-analyses are limited by imprecision and restricted to direct comparisons. We conducted a network meta-analysis of randomized clinical trials (RCTs) to examine the safety and efficacy of drugs available for SUP in critically ill patients.MethodsWe searched MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials through April 2017 for randomized controlled trials that examined the efficacy and safety of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), and sucralfate for SUP in critically ill patients. No date or language restrictions were applied. Data on study characteristics, methods, outcomes, and risk of bias were abstracted by two reviewers.ResultsOf 96 potentially eligible studies, we included 57 trials enrolling 7293 patients. The results showed that PPIs are probably more effective for preventing clinically important gastrointestinal bleeding (CIB) than H2RAs [odds ratio (OR) 0.38; 95% confidence interval (95% CI) 0.20, 0.73], sucralfate (OR 0.30; 95% CI 0.13, 0.69), and placebo (OR 0.24; 95% CI 0.10, 0.60) (all moderate quality evidence). There were no convincing differences among H2RA, sucralfate, and placebo. PPIs probably increase the risk of developing pneumonia compared with H2RAs (OR 1.27; 95% CI 0.96, 1.68), sucralfate (OR 1.65; 95% CI 1.20, 2.27), and placebo (OR 1.52; 95% CI 0.95, 2.42) (all moderate quality). Mortality is probably similar across interventions (moderate quality). Estimates of baseline risks of bleeding varied significantly across studies, and only one study reported on Clostridium difficile infection. Definitions of pneumonia varied considerably. Most studies on sucralfate predate pneumonia prevention strategies.ConclusionsOur results provide moderate quality evidence that PPIs are the most effective agents in preventing CIB, but they may increase the risk of pneumonia. The balance of benefits and harms leaves the routine use of SUP open to question.

Project description:BackgroundProton pump inhibitors (PPI) and histamine 2 receptor antagonists (H2RA) have been widely used as stress ulcer prophylaxis (SUP) in critically ill patients, however, its efficacy and safety remain unclear. This study aimed to assess the effect of SUP on clinical outcomes in critically ill adults.MethodsLiterature search was conducted in PubMed, EMBASE, Web of Science, and the Cochrane database of clinical trials for randomized controlled trials (RCTs) that investigated SUP, with PPI or H2RA, versus placebo or no prophylaxis in critically ill patients from database inception through 1 June 2019. Study selection, data extraction and quality assessment were performed in duplicate. The primary outcomes were clinically important gastrointestinal (GI) bleeding and overt GI bleeding. Conventional meta-analysis with random-effects model and trial sequential analysis (TSA) were performed.ResultsTwenty-nine RCTs were identified, of which four RCTs were judged as low risk of bias. Overall, SUP could reduce the incident of clinically important GI bleeding [relative risk (RR)?=?0.58; 95% confidence intervals (CI): 0.42-0.81] and overt GI bleeding (RR?=?0.48; 95% CI: 0.36-0.63), these results were confirmed by the sub-analysis of trials with low risk of bias, TSA indicated a firm evidence on its beneficial effects on the overt GI bleeding (TSA-adjusted CI: 0.31-0.75), but lack of sufficient evidence on the clinically important GI bleeding (TSA-adjusted CI: 0.23-1.51). Among patients who received enteral nutrition (EN), SUP was associated with a decreased risk of clinically important GI bleeding (RR?=?0.61; 95% CI: 0.44-0.85; TSA-adjusted CI: 0.16-2.38) and overt GI bleeding (RR?=?0.64; 95% CI: 0.42-0.96; TSA-adjusted CI: 0.12-3.35), but these benefits disappeared after adjustment with TSA. Among patients who did not receive EN, SUP had only benefits in reducing the risk of overt GI bleeding (RR?=?0.37; 95% CI: 0.25-0.55; TSA-adjusted CI: 0.22-0.63), but not the clinically important GI bleeding (RR?=?0.27; 95% CI: 0.04-2.09).ConclusionsSUP has benefits on the overt GI bleeding in critically ill patients who did not receive EN, however, its benefits on clinically important GI bleeding still needs more evidence to confirm.

Project description:BackgroundCritically ill infants with congenital heart disease (CHD) are often prescribed stress ulcer prophylaxis (SUP) to prevent upper gastrointestinal bleeding, despite the low incidence of stress ulcers and limited data on the safety and efficacy of SUP in infants. Recently, SUP has been associated with an increased incidence of hospital-acquired infections, community-acquired pneumonia, and necrotizing enterocolitis. The objective of this pilot study is to investigate the feasibility of performing a randomized controlled trial to assess the safety and efficacy of withholding SUP in infants with congenital heart disease admitted to the cardiac intensive care unit.MethodsA single center, prospective, double-blinded, randomized placebo-controlled pilot feasibility trial will be performed in infants with CHD admitted to the cardiac intensive care unit and anticipated to require respiratory support for > 24 h. Patients will be randomized to receive a histamine-2 receptor antagonist (H2RA) or placebo until they are discontinued from respiratory support. Randomization will be performed within 2 strata defined by admission type (medical or surgical) and age (neonate, age < 30 days, or infant, 1 month to 1 year). Allocation will be a 1:1 ratio using permuted blocks to ensure balanced allocations across the two treatment groups within each stratum. The primary outcomes include feasibility of screening, consent, timely allocation of study drug, and protocol adherence. The primary safety outcome is the rate of clinically significant upper gastrointestinal bleeding. The secondary outcomes are the difference in the relative and absolute abundance of the gut microbiota and functional microbial profiles between the two study groups. We plan to enroll 100 patients in this pilot study.DiscussionRoutine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects. The role of SUP in infants with CHD has not been examined, and there is equipoise on the risks and benefits of withholding this therapy. In addition, this therapy has been discontinued in other neonatal populations due to the concern for hospital-acquired infections and necrotizing enterocolitis. Furthermore, exploring changes to the microbiome after exposure to SUP may highlight the mechanisms by which SUP impacts potential microbial dysbiosis of the gut and its association with hospital-acquired infections. Assessment of the feasibility of a trial of withholding SUP in critically ill infants with CHD will facilitate planning of a larger multicenter trial of safety and efficacy of SUP in this vulnerable population.Trial registrationClinicalTrials.gov , NCT03667703. Registered 12 September 2018, https://clinicaltrials.gov/ct2/show/NCT03667703?term=SUPPRESS+CHD&draw=2&rank=1 . All WHO Trial Registration Data Set Criteria are met in this manuscript.

Project description:BackgroundThe incidence of malnutrition in children, who were admitted to the pediatric intensive care unit (PICU), has kept high level over the past 30 years. In addition, nutrition status of critically ill children deteriorates further during the changing of their conditions and may have a negative effect on patients' outcomes. This study aimed to determine the nutritional status of critically ill children and to survey current nutrition practices and support in PICU.MethodsIn this prospective observational study, 360 critically ill children stayed in the PICU not less than 3 days from Feb. to Nov. in 2017 were enrolled. Each patient underwent nutrition assessment. Nutritional status was determined using Z-scores of length/height-for-age (HAZ), weight-for-age (WAZ), weight-for-height (WHZ), body mass index-for-age (BAZ), based on the World Health Organization child growth standards. We also observed the patients' intake of calories and protein during the first 10 days after admission.ResultsThree hundred and sixty were enrolled in the study. One hundred and eighty-six patients (51.67%) were malnourished at PICU admission, above 50% and 56.45% (105/186) of malnourished patients had severe malnutrition. Except fasting in case of clinical instability in 5.3% (19/360), nutrition was provided in the form of oral feeding in 26.6% (96/360), enteral nutrition (EN) in 56.1% (202/360), parenteral nutrition (PN) in 6.4% (23/360) and mixed support (EN + PN) in 5.6% (20/360). Totally 384 times interruption of feeding happened in the process of EN, and 1.9 times feeding interruption happened to each patient. Twenty-seven point two percent of these patients had more than three times feeding interruption. The severe malnutrition group had significantly greater length of ICU stay and higher mechanical ventilation support rate (P=0.007, P=0.029). Total 44 (44/360, 12.22%) patients died in the study, and the malnutrition was not statistically different between survivor group and death group (P=0.379). More than 85% of the patients had lower daily nutritional intake compared with prescribed goals. Sixty-eight point three percent of the patients received the required calories during EN with median time of 2 [2-4] days. Only 32.7% of patients underwent EN received estimated protein requirements.ConclusionsThese results showed that malnutrition was common among children admitted to PICU. Furthermore, nutrition delivery was generally inadequate in critically ill children, and nutritional status was getting worsening during PICU.

Project description:BackgroundThe promotion of early mobilization following critical illness is tempered by national reports of patient and institutional barriers to this approach. We carried out a survey to assess current knowledge, perceptions and practices of Canadian physicians and physiotherapists with respect to acquired weakness and early mobilization in adults in the intensive care unit (ICU).MethodsWe conducted a cross-sectional, self-administered postal survey among critical care physicians and physiotherapists in all 46 academic ICUs in Canada in 2011-2012. To identify all physicians and physiotherapists working in the ICUs, we contacted division heads and senior physiotherapists by telephone or email. We designed, tested and administered a questionnaire with the following domains: knowledge of ICU-acquired weakness and early mobilization; personal views of, perceived barriers to and adequacy of technical skills for early mobilization; assessments for initiation of early mobilization and permissible activity levels by patient physiologic characteristics, diagnoses and therapies; staffing issues; and sedation practices.ResultsThe overall response rate was 71.3% (311/436); it was 64.2% (194/302) among physicians and 87.3% (117/134) among physiotherapists. A total of 214 respondents (68.8%) underestimated the incidence of ICU-acquired weakness in the general medical-surgical ICU population, and 186 (59.8%) stated they had insufficient knowledge or skills to mobilize patients receiving mechanical ventilation. Excessive sedation, medical instability, limited staffing, safety concerns, insufficient guidelines and insufficient equipment were common perceived barriers to early mobilization.InterpretationPhysicians and physiotherapists in the ICU underestimated the incidence of ICU-acquired weakness and felt inadequately trained to mobilize patients receiving mechanical ventilation. We identified multiple modifiable barriers to early mobilization at the institutional, health care provider and patient levels that need to be addressed when designing mobilization programs for critically ill adults.

Dataset Information

Need for a Randomized Controlled Trial of Stress Ulcer Prophylaxis in Critically Ill Children: A Canadian Survey.

Background

Objective

Methods

Results

Conclusions

Publications

Need for a Randomized Controlled Trial of Stress Ulcer Prophylaxis in Critically Ill Children: A Canadian Survey.

Similar Datasets

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