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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03374800




Registration number
NCT03374800
Ethics application status
Date submitted
21/11/2017
Date registered
15/12/2017

Titles & IDs
Public title
Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
Scientific title
Re-EValuating the Inhibition of Stress Erosions: Prophylaxis Against Gastrointestinal Bleeding in the Critically Ill (The REVISE) Trial
Secondary ID [1] 0 0
CCT38473
Universal Trial Number (UTN)
Trial acronym
REVISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Hemorrhage (Clinically Important, Upper) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo (0.9% saline)
Treatment: Drugs - Pantoprazole

Placebo comparator: Placebo (0.9% saline) - Withholding Stress ulcer prophylaxis (intravenous 0.9% saline as placebo)

Active comparator: Stress Ulcer Prophylaxis (Pantoprazole) - pantoprazole 40mg powder for injection reconstituted with 0.9% saline


Treatment: Drugs: Placebo (0.9% saline)
normal saline

Treatment: Drugs: Pantoprazole
40 mg powder for injection reconstituted with 0.9% saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of clinically important upper gastro-intestinal bleeding
Timepoint [1] 0 0
90 days (In ICU or resulting in ICU readmission, censored at 90 days after randomization)
Primary outcome [2] 0 0
Primary Safety Outcome: 90 Day Mortality
Timepoint [2] 0 0
90 days post randomization
Secondary outcome [1] 0 0
Rate of ventilator associated pneumonia (VAP) in ICU
Timepoint [1] 0 0
90 Days (while in ICU,censored at 90 days after randomization)
Secondary outcome [2] 0 0
Rate of Clostridioides difficile associated infection
Timepoint [2] 0 0
90 days (during the index hospital admission, censored at 90 days)
Secondary outcome [3] 0 0
New initiation of treatment with renal replacement therapy in ICU
Timepoint [3] 0 0
90 Days (In the ICU, censored at 90 days)
Secondary outcome [4] 0 0
Rate of all-cause-in-hospital mortality
Timepoint [4] 0 0
While in hospital, censored at 90 days after randomization
Secondary outcome [5] 0 0
Rate of ICU mortality
Timepoint [5] 0 0
While in the ICU, censored at 90 days after randomization
Secondary outcome [6] 0 0
Rate of patient important upper GI bleeding in ICU or resulting in ICU readmission, censored at 90 days after randomization
Timepoint [6] 0 0
Censored at 90 days after randomization

Eligibility
Key inclusion criteria
1. Age 18 years or more.
2. Receiving invasive mechanical ventilation in an ICU and in the opinion of the treating ICU physician mechanical ventilation will not be discontinued before the end of the day after tomorrow.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The treating clinician considers either Pantoprazole or placebo are indicated or contraindicated for this patient.
2. Pantoprazole contraindicated for patient due to local product information;

Australia/New Zealand;
* being treated with HIV protease inhibitors atazanavir or nelfinavir
* being treated with high dose methotrexate (i.e., greater than 300 mg as part of a chemotherapy regimen).
* documented cirrhosis or severe liver disease (for example as indicated by an INR greater than 5.0 due to underlying liver disease).

Canada;
* being treated with rilpivirine or atazanavir
* patients who are hypersensitive to pantoprazole, substituted benzimidazoles, or to any ingredient in the formulation
3. Patients in whom a PPI or histamine 2 receptor antagonist (H2RA) is indicated due to active bleeding or increased bleeding risk, defined as patients with acute GI bleeding, severe oesophagitis or peptic ulcer disease within the previous 8 weeks, Zollinger Ellison syndrome, Barrett's oesophagus or any previous admission to hospital because of upper GI bleeding (patients receiving PPIs for mild dyspepsia or mild gastroesophageal reflux disease or an uncertain indication are not excluded).
4. Received invasive mechanical ventilation during this ICU admission for 72 hours or more.
5. Patients who have received more than 24 hours treatment (i.e., more than one daily dose equivalent) with a PPI or H2RA during this ICU admission.
6. Being treated with or need for dual anti-platelet therapy.
7. Admitted for palliative care or the ICU physician is not committed to continuing life-sustaining therapies at the time of enrolment.
8. Known or suspected pregnancy.
9. Physician, patient, or substitute decision maker (SDM) declines.
10. Previously enrolled in the REVISE trial
11. Enrolled in another trial for which co-enrolment is not approved.

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
9/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2024
Sample size
Target
Accrual to date
Final
4800
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 0 0
Sutherland Hospital - Caringbah
Recruitment hospital [4] 0 0
Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [6] 0 0
St George Hospital - Kogarah
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [8] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [9] 0 0
Royal Brisbane Womens Hospital - Brisbane
Recruitment hospital [10] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [11] 0 0
Mater Hospital - South Brisbane
Recruitment hospital [12] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
Bendigo Health - Bendigo
Recruitment hospital [15] 0 0
Geelong University Hospital - Geelong
Recruitment hospital [16] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [17] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [18] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [19] 0 0
Epworth Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2050 - Caringbah
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
2747 - Kingswood
Recruitment postcode(s) [6] 0 0
2217 - Kogarah
Recruitment postcode(s) [7] 0 0
2050 - Saint Leonards
Recruitment postcode(s) [8] 0 0
2500 - Wollongong
Recruitment postcode(s) [9] 0 0
4029 - Brisbane
Recruitment postcode(s) [10] 0 0
4305 - Ipswich
Recruitment postcode(s) [11] 0 0
4101 - South Brisbane
Recruitment postcode(s) [12] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
3550 - Bendigo
Recruitment postcode(s) [15] 0 0
3220 - Geelong
Recruitment postcode(s) [16] 0 0
3084 - Heidelberg
Recruitment postcode(s) [17] 0 0
3004 - Melbourne
Recruitment postcode(s) [18] 0 0
3050 - Melbourne
Recruitment postcode(s) [19] 0 0
3121 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Nebraska
Country [2] 0 0
Brazil
State/province [2] 0 0
Campina Grande Do Sul
Country [3] 0 0
Brazil
State/province [3] 0 0
Governador Valadares
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Manitoba
Country [7] 0 0
Canada
State/province [7] 0 0
New Brunswick
Country [8] 0 0
Canada
State/province [8] 0 0
Nova Scotia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Canada
State/province [11] 0 0
Saskatchewan
Country [12] 0 0
Kuwait
State/province [12] 0 0
Kuwait City
Country [13] 0 0
Pakistan
State/province [13] 0 0
Islamabad
Country [14] 0 0
Saudi Arabia
State/province [14] 0 0
Riyadh
Country [15] 0 0
United Kingdom
State/province [15] 0 0
New Westminster

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Critical Care Trials Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
National Health and Medical Research Council, Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Deborah Cook, MD
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Following the publication of REVISE, the dataset will be used for secondary observational studies addressing additional hypothesis-driven questions (e.g., predictors of gastrointestinal bleeding). Access by REVISE investigators will follow a submitted rationale, analysis plan and approval by the Management Committee. Requests for access to the dataset by external academic investigators will be considered following a submitted rationale, analysis plan and approval by the Management Committee and research ethics boards as relevant. Only de-identified data will be provided and will be transferred via a secure web portal. Requirements will be stipulated in a pre-specified data sharing agreement with investigators which aligns with each institution including the data sharing policy of The George Institute (https://www.georgeinstitute.org.au/data-sharing-policy.)

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Anticipated availability 2025 for up to 15 years.
Available to whom?
Following the publication of REVISE, the dataset will be used for secondary observational studies addressing additional hypothesis-driven questions (e.g., predictors of gastrointestinal bleeding). Access by REVISE investigators will follow a submitted rationale, analysis plan and approval by the Management Committee. Requests for access to the dataset by external academic investigators will be considered following a submitted rationale, analysis plan and approval by the Management Committee and research ethics boards as relevant. Only de-identified data will be provided and will be transferred via a secure web portal. Requirements will be stipulated in a pre-specified data sharing agreement with investigators which aligns with each institution including the data sharing policy of The George Institute (https://www.georgeinstitute.org.au/data-sharing-policy.)
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03374800