Upper gastrointestinal tract bleeding acquired in a pediatric intensive care unit: Prophylaxis trial with cimetidine

Lacroix, Jacques; Infante‐Rivard, Claire; Gauthier, Marie; Rousseau, Élisabeth; Doesburg, N. Van

doi:10.1016/s0022-3476(86)80952-0

Cited by 47 publications

(26 citation statements)

References 13 publications

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“…We found four studies that evaluated a number of medications (cimetidine, almagate, ranitidine, sucralfate, and omeprazole) vs. no treatment or placebo for different outcomes; data were not available in all RCTs for each outcome (26,28,30,33).…”

Section: Treatment Versus No Treatmentmentioning

confidence: 99%

“…2), "treatment" (which included almagate, ranitidine, sucralfate, and omeprazole) was significantly more effective in preventing UGI bleeding (macroscopic or important bleeding) compared with "no treatment" (two studies ϭ 300 participants; RR, 0.41; 95% CI, 0.19 -0.91; I 2 ϭ 12%) (28,30). However, no significant difference was found when pooling both studies of treatment vs. no treatment with an additional RCT comparing treatment vs. placebo (three studies ϭ 340 participants; RR, 0.69; 95% CI, 0.41-1.17; I 2 ϭ 63%) (26,28,30). In addition, metaanalysis of two studies (30,33) found no significant difference in death rates among groups (two RCTs ϭ 132 participants; RR, 1.39; 95% CI, 0.70 -2.79; I 2 ϭ 4%).…”

Section: Treatment Versus No Treatmentmentioning

confidence: 99%

“…Lacroix et al (26) Double-blind randomized controlled trial Forty children from birth to 18 yrs old admitted to PICU. Inclusion criteria were that illness was severe enough to preclude any oral or enteral nutrition for at least 2 days.…”

Section: Sucralfatementioning

confidence: 99%

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Stress ulcer, gastritis, and gastrointestinal bleeding prophylaxis in critically ill pediatric patients: A systematic review

Revéiz

Guerrero‐Lozano

Camacho

et al. 2010

Pediatric Critical Care Medicine

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Section: Treatment Versus No Treatmentmentioning

confidence: 99%

Section: Treatment Versus No Treatmentmentioning

confidence: 99%

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Stress ulcer, gastritis, and gastrointestinal bleeding prophylaxis in critically ill pediatric patients: A systematic review

Revéiz

Guerrero‐Lozano

Camacho

et al. 2010

Pediatric Critical Care Medicine

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“…The probe was placed endoscopically in the body of the stomach. While patients were being treated with pirenzepine or famotidine daily samples of tracheal and gastric secretions were cul- Mean interval between surgery and gastroscopy (days) 6 4 Patients in stable haemodynamic condition (clinical score A) 22 25…”

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confidence: 99%

Frequency of stress lesions of the upper gastrointestinal tract in paediatric patients after cardiac surgery: effects of prophylaxis.

Behrens¹,

Hofbeck²,

Singer³

et al. 1994

Heart

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Background-Stress lesions of the upper gastrointestinal tract are well recognised in adult patients in intensive care. There are no controlled studies of the incidence of these lesions and the effects or side effects of prophylactic treatment in high risk paediatric patients. Methods-79 paediatric patients in intensive care were studied prospectively after operation for congenital heart disease. All patients had at least one endoscopic examination. The first 36 patients were not given prophylactic medication: later 43 children were treated randomly either with pirenzepine (n = 21) or with famotidine (n = 22). Gastric and tracheal secretions were taken daily for culture in those patients given prophylactic medication. Results-Severe inflammation or ulceration of the upper gastrointestinal tract was less common in those patients who were given prophylactic medication (18% v 44%). Prophylactic treatment did not, however, reduce the total incidence of postoperative stress lesions: it shifted the severity of these changes towards mild lesions and reduced the incidence of ulcerations from 25% to 2%. None of the patients developed a pneumonia caused by an organism previously isolated from the stomach. Conclusions-The incidence of stress lesions in children after cardiac surgery resembles that in high risk adult patients. 16-20%. 8-Antacids and H2 antagonists increase the gastric pH to >4. Pirenzepine is an anticholinergic agent that is highly specific for MI receptors of the stomach and reduces the production of hydrogen ions in the gastric mucosa. In addition it improves perfusion of the gastric mucosa, which leads to an increased production of mucus and bicarbonate," but does not change the gastric pH.There is evidence, however, that prophylactic treatment with antacids or H2 antagonists promoted bacterial overgrowth in the stomach and thus increased the risk of nosocomial pneumonia in adults.'2 1 ' Stress-induced ulcers of the upper gastrointestinal tract were detected in infants by pathological examinations in 1926.14 Nevertheless, so far there have been no controlled studies of the incidence of stress lesions and the effects of prophylactic treatment in infants and children in intensive care.'5 The purpose of our study was to obtain reliable data about the incidence of these lesions and about effects and side effects of prophylactic treatment in infants and children who underwent surgery for congenital heart disease.Patients and methods From October 1988 until November 1991 we prospectively examined 79 consecutive children who underwent corrective or palliative surgery for congenital heart disease. We did not include patients who had operations that usually have a short and uncomplicated postoperative recovery such as repair of an atrial septal defect, valvotomy for aortic stenosis, or repair of coarctation of the isthmus. The first 36 patients (group 1) were not given treatment to prevent lesions of the upper GI tract. Later, 43 patients (group 2) were randomised and treated either with pirenzepine, an a...

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“…The three trials (340 children) that reported macroscopic or important bleeding did not find a difference between prophylaxis and no prophylaxis (relative risk [RR] 0.71; 95% confidence interval [CI] 0.42 to 1.19, p = 0.19) [8–10]. The confidence interval is wide and the strength of inference is low as there were only 21 bleeding events.…”

Section: Introductionmentioning

confidence: 99%

Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial

Duffett

Choong

Foster

et al. 2017

Pilot Feasibility Stud

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BackgroundDespite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences—increasing the risk of nosocomial infections—which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT of stress ulcer prophylaxis with pantoprazole to prevent upper GI bleeding vs. placebo.MethodsA multi-centre blinded pilot RCT of 120 children in six Canadian PICUs. Children expected to require mechanical ventilation for more than 48 h will be randomized to receive intravenous pantoprazole 1 mg/kg or identical placebo once daily until they no longer need mechanical ventilation. We have four feasibility outcomes and will consider the trial successful if we achieve:Effective screening: If >80% of eligible patients are approached for consent.Timely enrollment: if >80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible.Participant accrual: If the average monthly enrolment is two or more participants per centre per month.Protocol adherence: if >90% of doses are administered according to the protocol. DiscussionThere are many uncertainties about the risks and benefits of stress ulcer prophylaxis. In an era of widespread use—where clinicians prescribe prophylaxis to the more severely ill—a large, rigorous RCT is required. A trial to determine if a strategy of withholding stress ulcer prophylaxis is not inferior to a strategy of routine stress ulcer prophylaxis will be challenging. A carefully designed and implemented pilot trial is essential.Trial registrationClinicalTrials.gov:NCT02929563 (Registered October 3, 2016).

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Upper gastrointestinal tract bleeding acquired in a pediatric intensive care unit: Prophylaxis trial with cimetidine

Cited by 47 publications

References 13 publications

Stress ulcer, gastritis, and gastrointestinal bleeding prophylaxis in critically ill pediatric patients: A systematic review

Stress ulcer, gastritis, and gastrointestinal bleeding prophylaxis in critically ill pediatric patients: A systematic review

Frequency of stress lesions of the upper gastrointestinal tract in paediatric patients after cardiac surgery: effects of prophylaxis.

Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial

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