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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2020
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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