Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02929563
Recruitment Status : Completed
First Posted : October 11, 2016
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Drug: Pantoprazole Drug: Placebo (for pantoprazole) Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial
Actual Study Start Date : January 9, 2017
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pantoprazole
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 Comparator: 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.
Drug: Placebo (for pantoprazole)



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Clinically important bleeding [ Time Frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) ]
    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.

  2. Nosocomial infections [ Time Frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) ]
    Ventilator associated pneumonia and C Difficile associated diarrhea

  3. Other gastrointestinal bleeding [ Time Frame: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days) ]
    Bleeding from the gastrointestinal tract that is not clinically important (using the above criteria).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929563


Locations
Layout table for location information
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital - London Health Science Centre
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada
Montreal Children's Hospital
Montréal, Quebec, Canada
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Mark Duffett, PhD McMaster University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02929563    
Other Study ID Numbers: 2173
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action