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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
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Scientific title
Re-EValuating the Inhibition of Stress Erosions: Prophylaxis Against Gastrointestinal Bleeding in the Critically Ill (The REVISE) Trial
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Secondary ID [1]
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CCT38473
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Universal Trial Number (UTN)
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Trial acronym
REVISE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Hemorrhage (Clinically Important, Upper)
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of clinically important upper gastro-intestinal bleeding
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Assessment method [1]
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Clinically important upper GI bleeding requires the presence of overt GI bleeding which is defined as one of the following;
* Hematemesis
* Overt nasogastric bleeding
* Melena
* Hematochezia
PLUS (in the absence of another cause), at least one of the following in the 24 hours following overt GI bleeding:
* Haemodynamic change defined as a spontaneous decrease in invasively monitored mean arterial pressure or non-invasive systolic or diastolic blood pressure of 20 mmHg or more or an orthostatic increase in pulse rate of 20 beats/minute and a decrease in systolic blood pressure of 10 mmHg, with or without vasopressor initiation, or increase
* Vasopressor initiation
* A decrease in haemoglobin of = 20 g/l in a 24-hour period or less,
* Transfusion of =2 units of packed red blood cells within 24 hours of bleeding to maintain stable haemoglobin or haemodynamics, or
* Need for therapeutic intervention (e.g. angiography, surgery or endoscopic treatment of bleeding).
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Timepoint [1]
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90 days (In ICU or resulting in ICU readmission, censored at 90 days after randomization)
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Primary outcome [2]
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Primary Safety Outcome: 90 Day Mortality
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Assessment method [2]
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Mortality status at day 90 post randomization
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Timepoint [2]
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90 days post randomization
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Secondary outcome [1]
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Rate of ventilator associated pneumonia (VAP) in ICU
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Assessment method [1]
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Diagnostic criteria for VAP include: previous mechanical ventilation for at least 48 hours, a new, progressive or persistent radiographic infiltrate on chest X-ray (without other obvious cause) plus at least 2 of the following 4 features:
* fever or hypothermia (temperature \>38 °C or \<36 °C)
* relative leukopenia or leukocytosis (WBC\<4.0 or \>12 x 10\^9/L)
* purulent sputum
* gas exchange deterioration Using these uploaded data, the Clinical Pulmonary Infection Score is calculated. A score of 6 or greater is the primary definition of ventilator-associated pneumonia
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Timepoint [1]
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90 Days (while in ICU,censored at 90 days after randomization)
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Secondary outcome [2]
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Rate of Clostridioides difficile associated infection
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Assessment method [2]
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We will use clinical features (diarrhea, ileus, toxic megacolon) and either microbiological evidence of toxin producing Clostridioides difficile or Pseudomembranous colitis on colonoscopy.
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Timepoint [2]
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90 days (during the index hospital admission, censored at 90 days)
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Secondary outcome [3]
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New initiation of treatment with renal replacement therapy in ICU
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Assessment method [3]
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Rate of New initiation of treatment with renal replacement therapy in ICU
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Timepoint [3]
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90 Days (In the ICU, censored at 90 days)
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Secondary outcome [4]
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Rate of all-cause-in-hospital mortality
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Assessment method [4]
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hospital mortality
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Timepoint [4]
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While in hospital, censored at 90 days after randomization
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Secondary outcome [5]
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Rate of ICU mortality
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Assessment method [5]
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ICU mortality
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Timepoint [5]
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While in the ICU, censored at 90 days after randomization
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Secondary outcome [6]
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Rate of patient important upper GI bleeding in ICU or resulting in ICU readmission, censored at 90 days after randomization
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Assessment method [6]
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Patient important upper GI bleeding in ICU or resulting in ICU readmission, censored at 90 days after randomization
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Timepoint [6]
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Censored at 90 days after randomization
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/01/2024
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Sample size
Target
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Accrual to date
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Final
4800
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [2]
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Blacktown Hospital - Blacktown
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Recruitment hospital [3]
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Sutherland Hospital - Caringbah
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Recruitment hospital [4]
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Gosford Hospital - Gosford
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Recruitment hospital [5]
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Nepean Hospital - Kingswood
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Recruitment hospital [6]
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St George Hospital - Kogarah
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Recruitment hospital [7]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [8]
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Wollongong Hospital - Wollongong
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Recruitment hospital [9]
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Royal Brisbane Womens Hospital - Brisbane
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Recruitment hospital [10]
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Ipswich Hospital - Ipswich
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Recruitment hospital [11]
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Mater Hospital - South Brisbane
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Recruitment hospital [12]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [13]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [14]
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Bendigo Health - Bendigo
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Recruitment hospital [15]
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Geelong University Hospital - Geelong
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Recruitment hospital [16]
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Austin Hospital - Heidelberg
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Recruitment hospital [17]
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Alfred Hospital - Melbourne
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Recruitment hospital [18]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [19]
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Epworth Hospital - Melbourne
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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2148 - Blacktown
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Recruitment postcode(s) [3]
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2050 - Caringbah
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Recruitment postcode(s) [4]
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2250 - Gosford
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Recruitment postcode(s) [5]
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2747 - Kingswood
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Recruitment postcode(s) [6]
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2217 - Kogarah
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Recruitment postcode(s) [7]
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2050 - Saint Leonards
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Recruitment postcode(s) [8]
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2500 - Wollongong
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Recruitment postcode(s) [9]
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4029 - Brisbane
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Recruitment postcode(s) [10]
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4305 - Ipswich
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Recruitment postcode(s) [11]
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4101 - South Brisbane
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Recruitment postcode(s) [12]
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4102 - Woolloongabba
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Recruitment postcode(s) [13]
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5000 - Adelaide
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Recruitment postcode(s) [14]
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3550 - Bendigo
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Recruitment postcode(s) [15]
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3220 - Geelong
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Recruitment postcode(s) [16]
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3084 - Heidelberg
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Recruitment postcode(s) [17]
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3004 - Melbourne
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Recruitment postcode(s) [18]
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3050 - Melbourne
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Recruitment postcode(s) [19]
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3121 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Nebraska
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Country [2]
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Brazil
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State/province [2]
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Campina Grande Do Sul
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Country [3]
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Brazil
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State/province [3]
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Governador Valadares
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Country [4]
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Canada
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State/province [4]
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Alberta
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Country [5]
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Canada
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State/province [5]
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British Columbia
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Country [6]
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Canada
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State/province [6]
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Manitoba
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Country [7]
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Canada
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State/province [7]
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New Brunswick
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Country [8]
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Canada
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State/province [8]
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Nova Scotia
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
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Canada
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State/province [10]
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Quebec
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Country [11]
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Canada
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State/province [11]
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Saskatchewan
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Country [12]
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Kuwait
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State/province [12]
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Kuwait City
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Country [13]
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Pakistan
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State/province [13]
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Islamabad
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Country [14]
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Saudi Arabia
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State/province [14]
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Riyadh
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Country [15]
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United Kingdom
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State/province [15]
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New Westminster
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Canadian Critical Care Trials Group
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Australian and New Zealand Intensive Care Society Clinical Trials Group
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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National Health and Medical Research Council, Australia
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding, many such patients around the world receive a drug called pantoprazole that decreases acid production. However, today, compared to decades ago, critically ill patients rarely develop upper gastrointestinal bleeding. This decrease is likely due to modern medicine, better resuscitation and earlier feeding. There may also be harms associated with pantoprazole and other drugs that reduce acid levels in the stomach including lung infections (pneumonia) and bowel infections (Clostridioides difficile). Studies in this area are old and of modest quality. Therefore, it is difficult to know whether pantoprazole does decrease stomach bleeding these days, or whether the possible harms of lung and bowel infections are actually more common and more serious problems. The goal of this international study is to determine if, in critically ill patients using breathing machines, the use of pantoprazole is effective in preventing bleeding from stomach ulcers or whether it causes more problems such as lung infection (pneumonia) and bowel infection (Clostridioides difficile), or whether pantoprazole has no effect at all. Whether the harms are worth the benefits, and whether the benefits are worth the costs, will be determined by an economic analysis to inform patients, families, clinicians, and healthcare systems globally.
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Trial website
https://clinicaltrials.gov/study/NCT03374800
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Deborah Cook, MD
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Address
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McMaster University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
Anticipated availability 2025 for up to 15 years.
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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.)
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Available for what types of analyses?
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How or where can data be obtained?
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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