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Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial (PIC-UP)

Primary Purpose

Gastrointestinal Hemorrhage

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Pantoprazole

Placebo (for pantoprazole)

About this trial

This is an interventional treatment trial for Gastrointestinal Hemorrhage

Eligibility Criteria

4 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

histamine-2 receptor antagonist (H2RA) or proton pump inhibitor (PPI) use for >1 week in the past month
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.
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

Sites / Locations

Alberta Children's Hospital
IWK Health Centre
McMaster Children's Hospital
Children's Hospital - London Health Science Centre
Children's Hospital of Eastern Ontario
CHU Sainte-Justine
Montreal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pantoprazole

placebo (for pantoprazole)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effective screening

We will consider the trial feasible if >80% of eligible patients are approached for consent.

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.

Participant accrual

We will consider the trial feasible if the average monthly enrollment is 2 or more participants per centre.

Protocol adherence

We will consider the trial feasible if >90% of doses are administered according to the protocol.

Secondary Outcome Measures

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.

Nosocomial infections

Ventilator associated pneumonia and C Difficile associated diarrhea

Other gastrointestinal bleeding

Bleeding from the gastrointestinal tract that is not clinically important (using the above criteria).

Full Information

NCT ID

NCT02929563

First Posted

October 3, 2016

Last Updated

September 1, 2020

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT02929563

Brief Title

Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

Acronym

PIC-UP

Official Title

Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

January 9, 2017 (Actual)

Primary Completion Date

January 2020 (Actual)

Study Completion Date

January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pantoprazole

Arm Type

Experimental

Arm Description

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.

Arm Title

placebo (for pantoprazole)

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Pantoprazole

Intervention Type

Drug

Intervention Name(s)

Placebo (for pantoprazole)

Primary Outcome Measure Information:

Title

Effective screening

Description

We will consider the trial feasible if >80% of eligible patients are approached for consent.

Time Frame