Gastrointestinal HemorrhagePhase 3PIC-UPNCT02929563
Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial
A Phase 3 study testing Pantoprazole in people with Gastrointestinal Hemorrhage, run by McMaster University at 7 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 4 months to 18 years
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Pantoprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 7 sitesCanada
- Study dates
- 9 Jan 2017to Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Alberta Children's Hospital
Calgary, Alberta
IWK Health Centre
Halifax, Nova Scotia
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Children's Hospital - London Health Science Centre
London, Ontario, N6A 5W9
CHU Sainte-Justine
Montreal, Quebec
Montreal Children's Hospital
Montreal, Quebec
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
About this study
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.
Read the 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.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Pantoprazole, Placebo (for pantoprazole)
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Placebo (for pantoprazole)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo (for pantoprazole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective screening
We will consider the trial feasible if >80% of eligible patients are approached for consent.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Secondary outcomes (3)
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.
Measured: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Nosocomial infections
Ventilator associated pneumonia and C Difficile associated diarrhea
Measured: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Other gastrointestinal bleeding
Bleeding from the gastrointestinal tract that is not clinically important (using the above criteria).
Measured: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study start9 Jan 2017
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Mark Duffett, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929563
- Sponsor's protocol ID
- 2173
- Acronym
- PIC-UP
- Status last verified
- Sep 2020
- First submitted
- 3 Oct 2016
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28533916
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial
- ClinicalTrials.gov ID
- NCT02929563
- Acronym / sponsor ID
- PIC-UP / 2173
- Conditions
- Gastrointestinal Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pantoprazole | Experimental | Drug: Pantoprazolepantoprazole 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. |
| placebo (for pantoprazole) | Placebo comparator | Drug: Placebo (for pantoprazole)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. |
Who may qualify
- Ages
- 4 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantoprazole | Drug | pantoprazole |
| Placebo (for pantoprazole) | Drug | placebo (for pantoprazole) |
Primary outcome
Effective screening
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
We will consider the trial feasible if >80% of eligible patients are approached for consent.
Timely enrollment
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
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
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
We will consider the trial feasible if the average monthly enrollment is 2 or more participants per centre.
Protocol adherence
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
We will consider the trial feasible if >90% of doses are administered according to the protocol.
3 secondary outcomes
Clinically important bleeding
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Nosocomial infections
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Other gastrointestinal bleeding
Time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 28533916Duffett 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Duffett, PhD principal investigator
McMaster University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pantoprazole in people with Gastrointestinal Hemorrhage, run by McMaster University at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective screening (time frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.