A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study)

Study protocol

Paul J. Young, Sean M. Bagshaw, Andrew Forbes, Alistair Nichol, Stephen E. Wright, Rinaldo Bellomo, Michael J Bailey, Richard W. Beasley, Glenn M. Eastwood, Marino Festa, David Gattas, Frank van Haren, Edward Litton, Paul Mouncey, Leanlove Navarra, David Pilcher, Diane Mackle, Colin J McArthur, Shay P. McGuinness, Manoj K. Saxena & 4 others Steve Webb, Kathryn M Rowan, Australian and New Zealand Intensive Care Society Clinical Trials Group, PEPTIC investigators

Research output: Contribution to journalArticleOtherpeer-review

Abstract

Background: The balance of risks and benefits with using proton pump inhibitors (PPIs) versus histamine-2 receptor blockers (H2RB) for stress ulcer prophylaxis in patients who are invasively ventilated in the intensive care unit (ICU) is uncertain. Objective: To describe the study protocol and statistical analysis plan for the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) study. Design, setting and participants: Protocol for a prospective, multicentre, randomised, open-label, cluster crossover, registry-embedded trial to be conducted in 50 ICUs in Australia, Canada, Ireland, New Zealand and the United Kingdom. The PEPTIC study will compare two approaches to stress ulcer prophylaxis in mechanically ventilated adults implemented at the level of the ICU. One approach is to use PPIs as the default therapy and the other approach is to use H2RBs as the default therapy when stress ulcer prophylaxis is prescribed. Each ICU, by random allocation, will use one approach for 6 months and will then switch to the opposite approach for the next 6 months. The PEPTIC study began recruitment in August 2016 and will complete recruitment in January 2019. Main outcome measures: The primary end point will be in-hospital mortality. Secondary outcomes include clinically significant upper gastrointestinal bleeding, Clostridium difficile infection, ICU length of stay and hospital length of stay. Results and conclusions: The PEPTIC study will compare the effect on in-hospital mortality of implementing, at the level of the ICU, the use of PPI as the preferred agent for stress ulcer prophylaxis in mechanically ventilated adults in the ICU with using H2RB as the preferred agent.

Original languageEnglish
Pages (from-to)182-189
Number of pages8
JournalCritical Care and Resuscitation
Volume20
Issue number3
Publication statusPublished - 1 Sep 2018

Cite this

Young, Paul J. ; Bagshaw, Sean M. ; Forbes, Andrew ; Nichol, Alistair ; Wright, Stephen E. ; Bellomo, Rinaldo ; Bailey, Michael J ; Beasley, Richard W. ; Eastwood, Glenn M. ; Festa, Marino ; Gattas, David ; van Haren, Frank ; Litton, Edward ; Mouncey, Paul ; Navarra, Leanlove ; Pilcher, David ; Mackle, Diane ; McArthur, Colin J ; McGuinness, Shay P. ; Saxena, Manoj K. ; Webb, Steve ; Rowan, Kathryn M ; Australian and New Zealand Intensive Care Society Clinical Trials Group ; PEPTIC investigators. / A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study) : Study protocol. In: Critical Care and Resuscitation. 2018 ; Vol. 20, No. 3. pp. 182-189.
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title = "A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study): Study protocol",
abstract = "Background: The balance of risks and benefits with using proton pump inhibitors (PPIs) versus histamine-2 receptor blockers (H2RB) for stress ulcer prophylaxis in patients who are invasively ventilated in the intensive care unit (ICU) is uncertain. Objective: To describe the study protocol and statistical analysis plan for the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) study. Design, setting and participants: Protocol for a prospective, multicentre, randomised, open-label, cluster crossover, registry-embedded trial to be conducted in 50 ICUs in Australia, Canada, Ireland, New Zealand and the United Kingdom. The PEPTIC study will compare two approaches to stress ulcer prophylaxis in mechanically ventilated adults implemented at the level of the ICU. One approach is to use PPIs as the default therapy and the other approach is to use H2RBs as the default therapy when stress ulcer prophylaxis is prescribed. Each ICU, by random allocation, will use one approach for 6 months and will then switch to the opposite approach for the next 6 months. The PEPTIC study began recruitment in August 2016 and will complete recruitment in January 2019. Main outcome measures: The primary end point will be in-hospital mortality. Secondary outcomes include clinically significant upper gastrointestinal bleeding, Clostridium difficile infection, ICU length of stay and hospital length of stay. Results and conclusions: The PEPTIC study will compare the effect on in-hospital mortality of implementing, at the level of the ICU, the use of PPI as the preferred agent for stress ulcer prophylaxis in mechanically ventilated adults in the ICU with using H2RB as the preferred agent.",
author = "Young, {Paul J.} and Bagshaw, {Sean M.} and Andrew Forbes and Alistair Nichol and Wright, {Stephen E.} and Rinaldo Bellomo and Bailey, {Michael J} and Beasley, {Richard W.} and Eastwood, {Glenn M.} and Marino Festa and David Gattas and {van Haren}, Frank and Edward Litton and Paul Mouncey and Leanlove Navarra and David Pilcher and Diane Mackle and McArthur, {Colin J} and McGuinness, {Shay P.} and Saxena, {Manoj K.} and Steve Webb and Rowan, {Kathryn M} and {Australian and New Zealand Intensive Care Society Clinical Trials Group} and {PEPTIC investigators}",
year = "2018",
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language = "English",
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Young, PJ, Bagshaw, SM, Forbes, A, Nichol, A, Wright, SE, Bellomo, R, Bailey, MJ, Beasley, RW, Eastwood, GM, Festa, M, Gattas, D, van Haren, F, Litton, E, Mouncey, P, Navarra, L, Pilcher, D, Mackle, D, McArthur, CJ, McGuinness, SP, Saxena, MK, Webb, S, Rowan, KM, Australian and New Zealand Intensive Care Society Clinical Trials Group & PEPTIC investigators 2018, 'A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study): Study protocol', Critical Care and Resuscitation, vol. 20, no. 3, pp. 182-189.

A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study) : Study protocol. / Young, Paul J.; Bagshaw, Sean M.; Forbes, Andrew; Nichol, Alistair; Wright, Stephen E.; Bellomo, Rinaldo; Bailey, Michael J; Beasley, Richard W.; Eastwood, Glenn M.; Festa, Marino; Gattas, David; van Haren, Frank; Litton, Edward; Mouncey, Paul; Navarra, Leanlove; Pilcher, David; Mackle, Diane; McArthur, Colin J; McGuinness, Shay P.; Saxena, Manoj K.; Webb, Steve; Rowan, Kathryn M; Australian and New Zealand Intensive Care Society Clinical Trials Group; PEPTIC investigators.

In: Critical Care and Resuscitation, Vol. 20, No. 3, 01.09.2018, p. 182-189.

Research output: Contribution to journalArticleOtherpeer-review

TY - JOUR

T1 - A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study)

T2 - Study protocol

AU - Young, Paul J.

AU - Bagshaw, Sean M.

AU - Forbes, Andrew

AU - Nichol, Alistair

AU - Wright, Stephen E.

AU - Bellomo, Rinaldo

AU - Bailey, Michael J

AU - Beasley, Richard W.

AU - Eastwood, Glenn M.

AU - Festa, Marino

AU - Gattas, David

AU - van Haren, Frank

AU - Litton, Edward

AU - Mouncey, Paul

AU - Navarra, Leanlove

AU - Pilcher, David

AU - Mackle, Diane

AU - McArthur, Colin J

AU - McGuinness, Shay P.

AU - Saxena, Manoj K.

AU - Webb, Steve

AU - Rowan, Kathryn M

AU - Australian and New Zealand Intensive Care Society Clinical Trials Group

AU - PEPTIC investigators

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Background: The balance of risks and benefits with using proton pump inhibitors (PPIs) versus histamine-2 receptor blockers (H2RB) for stress ulcer prophylaxis in patients who are invasively ventilated in the intensive care unit (ICU) is uncertain. Objective: To describe the study protocol and statistical analysis plan for the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) study. Design, setting and participants: Protocol for a prospective, multicentre, randomised, open-label, cluster crossover, registry-embedded trial to be conducted in 50 ICUs in Australia, Canada, Ireland, New Zealand and the United Kingdom. The PEPTIC study will compare two approaches to stress ulcer prophylaxis in mechanically ventilated adults implemented at the level of the ICU. One approach is to use PPIs as the default therapy and the other approach is to use H2RBs as the default therapy when stress ulcer prophylaxis is prescribed. Each ICU, by random allocation, will use one approach for 6 months and will then switch to the opposite approach for the next 6 months. The PEPTIC study began recruitment in August 2016 and will complete recruitment in January 2019. Main outcome measures: The primary end point will be in-hospital mortality. Secondary outcomes include clinically significant upper gastrointestinal bleeding, Clostridium difficile infection, ICU length of stay and hospital length of stay. Results and conclusions: The PEPTIC study will compare the effect on in-hospital mortality of implementing, at the level of the ICU, the use of PPI as the preferred agent for stress ulcer prophylaxis in mechanically ventilated adults in the ICU with using H2RB as the preferred agent.

AB - Background: The balance of risks and benefits with using proton pump inhibitors (PPIs) versus histamine-2 receptor blockers (H2RB) for stress ulcer prophylaxis in patients who are invasively ventilated in the intensive care unit (ICU) is uncertain. Objective: To describe the study protocol and statistical analysis plan for the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) study. Design, setting and participants: Protocol for a prospective, multicentre, randomised, open-label, cluster crossover, registry-embedded trial to be conducted in 50 ICUs in Australia, Canada, Ireland, New Zealand and the United Kingdom. The PEPTIC study will compare two approaches to stress ulcer prophylaxis in mechanically ventilated adults implemented at the level of the ICU. One approach is to use PPIs as the default therapy and the other approach is to use H2RBs as the default therapy when stress ulcer prophylaxis is prescribed. Each ICU, by random allocation, will use one approach for 6 months and will then switch to the opposite approach for the next 6 months. The PEPTIC study began recruitment in August 2016 and will complete recruitment in January 2019. Main outcome measures: The primary end point will be in-hospital mortality. Secondary outcomes include clinically significant upper gastrointestinal bleeding, Clostridium difficile infection, ICU length of stay and hospital length of stay. Results and conclusions: The PEPTIC study will compare the effect on in-hospital mortality of implementing, at the level of the ICU, the use of PPI as the preferred agent for stress ulcer prophylaxis in mechanically ventilated adults in the ICU with using H2RB as the preferred agent.

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JO - Critical Care and Resuscitation

JF - Critical Care and Resuscitation

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