Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

NCT02929563 | Completed Phase 3 DMC

• 1 other identifier: 2173
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Gastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (3)

• Clinically important bleeding

  During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)

• Nosocomial infections

  During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)

• Other gastrointestinal bleeding

  During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)

Study Arms (2)

pantoprazole

EXPERIMENTAL

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

placebo (for pantoprazole)

PLACEBO COMPARATOR

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)

Interventions

Pantoprazole DRUG

pantoprazole

Placebo (for pantoprazole) DRUG

placebo (for pantoprazole)

Eligibility Criteria

• Age: 4 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• less than 18 years of age
• \>4 months of age
• requires respiratory support in the form of invasive mechanical ventilation, non-invasive mechanical ventilation, or high-flow oxygen
• the attending physician expects the child to require respiratory support for at least 2 more days

You may not qualify if:

• histamine-2 receptor antagonist (H2RA) or proton pump inhibitor (PPI) use for \>1 week in the past month
• documented severe reflux, active H. pylori infection, severe esophagitis, Zollinger Ellison syndrome, Barrett's esophagus, peptic ulcer bleeding within 8 weeks
• 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
• are receiving mycophenolate (enteral), methotrexate, nelfinavir, atazanavir, saquinavir, posaconazole
• chronic ventilation on usual pressure settings and rate
• nocturnal or intermittent non-invasive ventilation only
• are eating, nursing, or if chronically fed via feeding tube, receiving usual feeds
• received more than 1 daily-dose equivalent of acid suppressive medication in the PICU
• were previously enrolled in this trial
• are currently enrolled in a potentially confounding trial
• are known to be pregnant or breastfeeding
• are known to be allergic to pantoprazole or any other ingredient in the product
• are not expected to survive this PICU admission because of palliative care or limited life support

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (7)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital - London Health Science Centre

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, Canada

Location

Related Publications (1)

• Duffett M, Choong K, Foster J, Gilfoyle E, Lacroix J, Pai N, Thabane L, Cook DJ; Canadian Critical Care Trials Group. Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial. Pilot Feasibility Stud. 2017 May 19;3:26. doi: 10.1186/s40814-017-0142-y. eCollection 2017.

  PMID: 28533916 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mark Duffett, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 11, 2016
• Study Start: January 9, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

CA (7)