Status:
COMPLETED
Re-Evaluating the Inhibition of Stress Erosions: Gastrointestinal Bleeding Prophylaxis In ICU
Lead Sponsor:
McMaster University
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Stress Ulcer Prophylaxis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the this Pilot Trial is to determine the feasibility of conducting a large randomized controlled trial (RCT), that aims to examine the efficacy and safety of using pantoprazole compared...
Detailed Description
Background For almost 4 decades, stress ulcer prophylaxis to prevent upper gastrointestinal (GI) bleeding has been standard of care in the ICU. The 1999 American Society of Health-System Pharmacists g...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years
- Anticipated invasive mechanical ventilation of ≥48 hours, determined by the intensivist
Exclusion
- Invasive mechanical ventilation \>72 hours before randomization.
- Patients who must receive PPI due to active bleeding or increased bleeding risk (e.g., patients with acute GI bleeding, recent severe esophagitis, Zollinger Ellison syndrome, Barrett's esophagus, peptic ulcer bleeding within 8 weeks \[mild dyspepsia or mild gastroesophageal reflex disease will not be excluded\])
- Receiving dual antiplatelet therapy aspirin and clopidogrel prior to randomization
- Palliative care or decision to withdraw advanced life support (patients with a decision to forgo cardiopulmonary resuscitation will not be excluded)
- Previous enrolment in this or a related trial
- Pregnancy
- Physician, patient, or substitute decision maker (SDM) declines
- Two or more 'daily doses' of prophylaxis with H2RA or PPI (one day of a single PPI dose is not an exclusion criterion if once daily dosing of PPI prophylaxis was administered; one day of bid \[twice daily\] dosing of an H2RA is not an exclusion criterion if twice daily H2RA prophylaxis was administered; one day of tid \[thrice daily\] dosing of an H2RA is not an exclusion criterion if thrice daily H2RA prophylaxis was administered).
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT02290327
Start Date
May 1 2015
Last Update
February 8 2016
Active Locations (10)
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1
Royal Adelaide
Adelaide, Australia
2
Queen Elizabeth II
Halifax, Nova Scotia, Canada
3
St. Joseph's HealthCare Hospital
Hamilton, Ontario, Canada, L9K 1N3
4
Jurvinski Hospital
Hamilton, Ontario, Canada