NCT02929563

Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 4 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Despite sparse pediatric data on the effectiveness of stress ulcer prophylaxis to prevent gastrointestinal (GI) bleeding, 60% of critically ill children receive these medications. This may have unintended consequences - increasing the risk of nosocomial infections - which may be more serious and common than bleeding these drugs are prescribed to prevent. A large randomized trial (RCT) is needed to assess the balance of these risks and benefits, to determine if a strategy of withholding stress ulcer prophylaxis in critically ill children is not inferior to a strategy of routine stress ulcer prophylaxis. RCTs in pediatric critical care are exceptionally challenging to complete; thus, a rigorous pilot RCT is crucial. The pilot may prevent pursuit of a trial that is ultimately not feasible - which is ethically and financially responsible. It is more likely that this carefully designed pilot trial will ensure that the larger trial we undertake is successful.

Conditions

• Gastrointestinal Hemorrhage

Interventions

Type	Name	Description
DRUG	Pantoprazole
DRUG	Placebo (for pantoprazole)

Timeline

• Start date: 2017-01-09
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2016-10-11
• Last updated: 2020-09-02

Locations

7 sites across 1 country: Canada