A Phase 3 interventional study of Pantoprazole and Placebo (for pantoprazole) in Gastrointestinal Hemorrhage, sponsored by McMaster University. Completed at 7 sites in Canada. Open to participants aged 4 Months to 18 Years. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by McMaster University · Phase 3, Interventional, and Treatment
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.
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 116 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
pantoprazole 1 mg/kg (maximum 40 mg) IV once daily until the participants no longer need mechanical ventilation - to a maximum of 30 days or until Pediatric Intensive Care Unit (PICU) discharge.
Drug: Pantoprazole
an equivalent volume of normal saline IV once daily until the participants no longer need mechanical ventilation - to a maximum of 30 days or until PICU discharge.
Drug: Placebo (for pantoprazole)
Effective screening
We will consider the trial feasible if \>80% of eligible patients are approached for consent.
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Timely enrollment
We will consider the trial feasible if \>80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible.
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Participant accrual
We will consider the trial feasible if the average monthly enrollment is 2 or more participants per centre.
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Protocol adherence
We will consider the trial feasible if \>90% of doses are administered according to the protocol.
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Clinically important bleeding
Overt bleeding from the GI tract (can be hematemesis, nasogastric blood, melena, hematochezia) associated with one of the following within 24 hours: a decrease in hemoglobin of \>20 g/L, hypotension (a decrease in systolic blood pressure of \>10 mmHg or the need for new or increased doses of vasoactive medications), tachycardia (an increase in heart rate of \>20 beats per minute) or a red blood cell transfusion.
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Nosocomial infections
Ventilator associated pneumonia and C Difficile associated diarrhea
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Other gastrointestinal bleeding
Bleeding from the gastrointestinal tract that is not clinically important (using the above criteria).
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Plan to share: Undecided
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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