Gastrointestinal Hemorrhage Clinical Trial
— PIC-UPOfficial title:
Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial
NCT number | NCT02929563 |
Other study ID # | 2173 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | January 9, 2017 |
Est. completion date | January 2020 |
Verified date | September 2020 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Months to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital | Hamilton | Ontario |
Canada | Children's Hospital - London Health Science Centre | London | Ontario |
Canada | CHU Sainte-Justine | Montreal | Quebec |
Canada | Montreal Children's Hospital | Montréal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effective screening | We will consider the trial feasible if >80% of eligible patients are approached for consent. | During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) | |
Primary | 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. | During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) | |
Primary | Participant accrual | We will consider the trial feasible if the average monthly enrollment is 2 or more participants per centre. | During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) | |
Primary | Protocol adherence | We will consider the trial feasible if >90% of doses are administered according to the protocol. | During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) | |
Secondary | 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. | During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) | |
Secondary | Nosocomial infections | Ventilator associated pneumonia and C Difficile associated diarrhea | During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) | |
Secondary | Other gastrointestinal bleeding | Bleeding from the gastrointestinal tract that is not clinically important (using the above criteria). | During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) |
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