ANZICS CTG Endorsed Study

PEPTIC

A multi-centre, cluster cross over, randomised registry trial comparing the safety and efficacy of proton pump inhibitors with histamine-2 receptor blockers for ulcer prophylaxis in intensive care patients

Study Description

The PEPTIC Study will use a cluster crossover registry design to compare proton pump inhibitors (PPI) and histamine-2 receptor blockers as the default therapy for ulcer prophylaxis in mechanically ventilated patients in ICU.  The study will provide robust estimates of the relative risk of stress-related upper gastrointestinal (GI) bleeding and complications that are potentially related to using PPIs vs H2RBs for stress ulcer prophylaxis.  During the first treatment period, half of the participating ICUs will be randomly assigned to use PPIs for stress ulcer prophylaxis in patients who require life-support while the other half will use H2RBs.  During the second treatment period each ICU will swap to using the opposite treatment.  Data will be collected primarily from existing data sources rather than the medical records of individual patients.  There will be two study treatment periods.  The primary endpoint is in hospital mortality (censored at 90 days).

Management Committee

Paul Young (Chair), Michael Bailey, Richard Beasley, Rinaldo Bellomo, Glenn Eastwood, Marino Festa, Andrew Forbes, David Gattas, Frank van Haren, Ed Litton, David Pilcher, Diane Mackle (Project Manager), Shay McGuinness, Alistair Nichol, Manoj Saxena, Steve Webb, Sean Bagshaw, Paul Mouncey and Stephen Wright.

Project Managers

Leanlove Navarra
Diane Mackle

Administering Institution

Medical Research Institute of New Zealand

Collaborators

Austin Hospital
Irish Health Research Board
Alberta Health Services
Intensive Care National Audit & Research Centre (ICNARC)

Sample Size

n/a

Funding

Intensive Care Foundation Project Grant $20,000 AUS (refunded in 2014) Irish Health Research Board EUR 200,000
Health Research Council of New Zealand Partnership and Health Delivery Grant NZ$200,000
Intensive Care Foundation A$25,000 (2018)

Project Status as of June 2018

26 sites have completed and finished the PEPTIC Study. 2 more sites from Australia will finish by July 2018.  Canadian sites will finish October 2018 and the last batch of sites in United Kingdom will finish 01 January 2019.

After completing the study period in the PEPTIC Study, sites are requested to complete their complication log which includes upper GI bleed and Clostridium difficile infection.

Reference

CTG 1415-01
ACTRN12616000481471

Contact

Paul Young (email)