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Stress Ulcer Prophylaxis versus Placebo - a Blinded Randomized Control Trial toEvaluate the Safety of Two Strategies in Critically Ill Infants with Congenital Heart Disease (SUPPRESS-CHD)
- Source :
- Trials, Vol 21, Iss 1, Pp 1-9 (2020), Trials
- Publication Year :
- 2020
- Publisher :
- Research Square Platform LLC, 2020.
-
Abstract
- Background Critically 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. Methods A 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 Discussion Routine 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 registration ClinicalTrials.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.
- Subjects :
- Heart Defects, Congenital
Pediatrics
medicine.medical_specialty
Peptic Ulcer
Critical Illness
Pediatric intensive care
Medicine (miscellaneous)
Pilot Projects
Placebo
Gastrointestinal hemorrhage
law.invention
03 medical and health sciences
Study Protocol
0302 clinical medicine
H2 blocker
Randomized controlled trial
Double-Blind Method
law
Multicenter trial
medicine
Humans
Pharmacology (medical)
Prospective Studies
Adverse effect
Enterocolitis, Pseudomembranous
030304 developmental biology
Randomized Controlled Trials as Topic
Congenital heart disease
0303 health sciences
Cross Infection
lcsh:R5-920
business.industry
Stress ulcer
Infant
030208 emergency & critical care medicine
Pneumonia
medicine.disease
Anti-Ulcer Agents
Intensive Care Units
Pediatric critical care
Pediatric cardiac critical care
Histamine H2 Antagonists
Necrotizing enterocolitis
Coronary care unit
Upper gastrointestinal bleeding
Microbiome
business
Infection
lcsh:Medicine (General)
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Trials, Vol 21, Iss 1, Pp 1-9 (2020), Trials
- Accession number :
- edsair.doi.dedup.....5839352483843e237c9e546c102b7b70