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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02290327




Registration number
NCT02290327
Ethics application status
Date submitted
31/10/2014
Date registered
14/11/2014
Date last updated
8/02/2016

Titles & IDs
Public title
Re-Evaluating the Inhibition of Stress Erosions: Gastrointestinal Bleeding Prophylaxis In ICU
Scientific title
Secondary ID [1] 0 0
REV-06MAR14
Universal Trial Number (UTN)
Trial acronym
REVISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress Ulcer Prophylaxis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pantoprazole
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - 50 ml of 0.9% Normal Saline Intravenously once daily

Active Comparator: Pantoprazole - Pantoprazole 40 mg in 50 ml 0.9% Normal Saline Intravenously once daily


Treatment: Drugs: Pantoprazole
Proton pump inhibitor

Treatment: Drugs: Placebo
50 ml of 0.9% normal saline

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Consent Rate - This will be calculated as the overall proportion of consented patients of those substitute decision makers (SDMs) approached (with 95% CI).
A successful consent rate will be defined as =70% of SDMs approached to consent.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Recruitment Rate - A successful recruitment rate will be defined as achieving enrolment of 90 patients, conventionally expressed as 2 patients per center per month over 12 months.
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Protocol Adherence - This will be calculated as doses of study drug administered as a proportion of doses prescribed and associated 95% confidence intervals.
A successful adherence will be defined as =80% of prescribed drugs being administered.
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Clinically important upper gastrointestinal bleeding
Timepoint [1] 0 0
During ICU stay (expected average is 10 days)
Secondary outcome [2] 0 0
Ventilator associated pneumonia
Timepoint [2] 0 0
During ICU stay (expected average is 10 days)
Secondary outcome [3] 0 0
Mortality
Timepoint [3] 0 0
During ICU and hospital stay (expected average ICU stay is 10 days, expected average hospital stay is 30 days)
Secondary outcome [4] 0 0
Clostridium Difficile infection
Timepoint [4] 0 0
During ICU stay (expected average ICU stay is 10 days)

Eligibility
Key inclusion criteria
1. Adults = 18 years

2. Anticipated invasive mechanical ventilation of =48 hours, determined by the
intensivist
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Invasive mechanical ventilation >72 hours before randomization.

2. 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])

3. Receiving dual antiplatelet therapy aspirin and clopidogrel prior to randomization

4. Palliative care or decision to withdraw advanced life support (patients with a
decision to forgo cardiopulmonary resuscitation will not be excluded)

5. Previous enrolment in this or a related trial

6. Pregnancy

7. Physician, patient, or substitute decision maker (SDM) declines

8. 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Nova Scotia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Saudi Arabia
State/province [3] 0 0
Eastern Province

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Physicians' Services Incorporated Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 to placebo for stress ulcer prophylaxis in critically ill mechanically
ventilated patients in the ICU.
Trial website
https://clinicaltrials.gov/show/NCT02290327
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Waleed Alhazzani, MD,FRCPC,MSc
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications