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Table 2 Eligibility criteria

From: Stress ulcer prophylaxis versus placebo—a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD)

Inclusion criteria (1) < 12 months of age (including premature newborns)
(2) Diagnosed with congenital heart disease*
(3) Admitted to the CICU
(4) Anticipated to require respiratory support for > 24 h during their CICU stay
(5) Have received ≤ 1 dose of stress ulcer prophylaxisβ during their current admission
Exclusion criteria (1) Prior use of antacidsβ in the past month for > 7 days
(2) Active gastrointestinal bleeding
(3) Active Helicobacter pylori infection
(4) Anticipated exposure to certain pharmaceuticals:
 (i) High-dose steroids (equivalent to 4 mg/kg/day of methylprednisolone)
 (ii) Intravenous non-steroidal anti-inflammatory drugs (i.e., ketorolac)
 (iii) Certain anticoagulants including high-dose aspirin, direct thrombin inhibitors, and GPIIbIIIa inhibitors
(5) Planned to undergo or recently has undergone gastrointestinal surgery within the last 4 weeks
(6) Supported by ECMO or VAD
(7) Currently enrolled in another conflicting interventional trial
(8) Known to be allergic to H2RAs
(9) Admitted for palliative care
(10) Prior enrollment in the study
(11) Primary provider declines enrollment
  1. CICU cardiac intensive care unit, H2RA histamine-2 receptor antagonist, PPI proton pump inhibitor, GIIbIIIa glycoprotein IIb/IIIa, ECMO extracorporeal membrane oxygenator, VAD ventricular assist device
  2. *CHD includes anatomic, myopathic, and arrhythmic conditions
  3. Respiratory support includes mechanical ventilation, non-invasive positive pressure ventilation, and high-flow oxygen therapy
  4. βStress ulcer prophylaxis or antacids include H2RAs, PPIs, and sucralfate