ANZICS CTG Endorsed Study

REVISE

The re-evaluating the inhibition of stress erosions trial

Study Description

There is currently inadequate evidence to support the widespread current practice of stress ulcer prophylaxis through the daily administration of pantoprazole. Current data indicate that despite the increase in proton pump inhibitor administration the prevalence of clinically important gastrointestinal bleeding is unaffected. There are theoretical reasons and existing data which suggest that current practice may harm. It is likely that use of proton pump inhibitors increase the risk of ventilator-associated pneumonia, which is estimated to carry an attributable mortality of at least 6% and to increase hospital length of stay by approximately 6 days, and Clostridium difficile infection. Accordingly, a definitive methodologically rigorous study is needed to establish whether routine proton pump inhibitor administration results in net benefit or harm.

Management Committee

ANZ MC: Adam Deane (Co-Chair), Simon Finfer (Co-Chair), , Frances Bass, Marianne Chapman,  Serena Knowles, John Myburgh, Alexis Poole,  Bala Venkatesh and Paul Young.

International MC: Waleed Alhazzani, Deborah Cook (Chair), Adam Deane, Simon Finfer, Gordon Guyatt, Serena Knowles, John Marshall, John Myburgh, Alexis Poole, Lehana Thabane, Paul Young, Nicole Zytaruk

Administering Institution

The George Institute for Global Health

Collaborators

Canadian Critical Care Trials Group (McMaster University)

Sample Size

4800 patients

Funding

NHMRC Project Grant $2,955,000
CIHR $1,819,350

Project Status as of June 2018

Start-up activities for REVISE are progressing well.

Canadian update:

The Canadian randomisation website is active, however no recruitments yet. The official Canadian Start Up Meeting will be held in early June. A number of Canadian sites already have full approvals in place. The CRF and database are in the final stages of development.

Australian and New Zealand update:

Study drug in AUS/NZ will be supplied as blinded vials of either pantoprazole or placebo that will need to be reconstituted at the bedside (similar to ADRENAL trial). The Service Agreement between TGI and the company who will supply the study drug has been signed. Details for product manufacture, labelling and packaging are currently being finalised. Estimate that first supply of study drug will be available in 4th quarter of 2018. The active product will be supplied through Takeda Pharmaceuticals Australia, and is not currently listed in the current study Protocol (V2.0, dated 28 September 2017). Hence a minor Protocol amendment is required to cover AUS/NZ study drug.

AUS/NZ will require a separate randomisation website, to accommodate medication kit allocation, re-supply and site stock management. The George Institute’s GDS website (used for ADRENAL) will be used. This is currently being built, ensuring that randomisation will occur the same as for Canada.

A further call for EOIs from interested AUS/NZ sites went out in May 2018. Site feasibility assessments are underway.

The international management committee has met regularly. The ANZ management committee has receive study updates on progress and has had the first meeting with plans to meet regularly during the start-up phase for ANZ.

Options for the Start Up Meeting for AUS/NZ are currently being explored.

Reference

CTG 1617-02

Contact

Adam Deane (email)
Study email