Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

Gastrointestinal Hemorrhage Clinical Trial

— PIC-UP  

Official title:

Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929563
• Other study ID #: 2173
• Status: Completed
• Phase: Phase 3
• Start date: January 9, 2017
• Est. completion date: January 2020

Study information

• Verified date: September 2020
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Drug:
• Pantoprazole

• Placebo (for pantoprazole)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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)