Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study tests the feasibility of a large study of stress ulcer prophylaxis in critically ill children. Children admitted to the Pediatric Intensive Care Unit who are expected to require mechanical ventilation for more than 48 hours will be randomized to intravenous pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical ventilation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Pantoprazole

Criteria

Inclusion Criteria:

1. less than 18 years of age

2. >4 months of age

3. requires respiratory support in the form of invasive mechanical ventilation, non-invasive mechanical ventilation, or high-flow oxygen

4. the attending physician expects the child to require respiratory support for at least 2 more days

Exclusion Criteria:

1. histamine-2 receptor antagonist (H2RA) or proton pump inhibitor (PPI) use for >1 week in the past month

2. active GI bleeding Blood in the nasogastric (NG) tube or coffee-ground emesis suspected by the attending physician to be from the oropharynx is not an exclusion criterion.

3. documented severe reflux, active H. pylori infection, severe esophagitis, Zollinger Ellison syndrome, Barrett's esophagus, peptic ulcer bleeding within 8 weeks

4. are receiving methylprednisolone 15 mg/kg/day or more (or equivalent) Equivalent doses: methylprednisolone, prednisone or prednisolone 15 mg/kg/day; dexamethasone 3 mg/kg/day; hydrocortisone 60 mg/kg/day

5. are receiving mycophenolate (enteral), methotrexate, nelfinavir, atazanavir, saquinavir, posaconazole

6. chronic ventilation on usual pressure settings and rate

7. nocturnal or intermittent non-invasive ventilation only

8. are eating, nursing, or if chronically fed via feeding tube, receiving usual feeds

9. received more than 1 daily-dose equivalent of acid suppressive medication in the PICU

10. were previously enrolled in this trial

11. are currently enrolled in a potentially confounding trial

12. are known to be pregnant or breastfeeding

13. are known to be allergic to pantoprazole or any other ingredient in the product

14. are not expected to survive this PICU admission because of palliative care or limited life support