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. Following the recent publication of SUPICU trial results (Krag, M. N Engl J Med 2018, 379), current data indicate that despite the increase in proton pump inhibitor administration the question of whether ICU patients should receive pantoprazole remains.

There are theoretical reasons and existing data which suggest that the use of proton pump inhibitors may 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), , Marianne Chapman, Naomi Hammond, Miranda Hardy, Serena Knowles, John Myburgh, Alexis Poole, Dorrilyn Rajbhandari, 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 2019

The protocol has been amended and approved by the International Management Committee following publication of the SUPICU trial results. Protocol version 3.0 has been approved for use in Canada. Preparation for ethics submission in Australia and New Zealand is currently underway. The first patient has been enrolled in Canada, with two sites activated. Vanguard Australian sites will commence as soon as possible after ethics approval for the amended protocol.

Reference

CTG1617-02

Contact

Adam Deane (email)
Study email