Proton Pump Inhibitors vs. Histamine-2 REceptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit

Phase 3

Completed

• Conditions: Critical illness; Mechanical ventilation; Ulcer prophylaxis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616000481471
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

1. Research question The PEPTIC study compared two types of medicine that are commonly used for preventing stress ulcers in Intensive Care Unit (ICU) patients who require life support, to understand which medicine led to the lowest risk of death, bleeding from the gut), prolonged life support, and Clostridioides difficile infection (a serious infection of the bowel). 2. Background information Patients who require treatment in the Intensive Care Unit (ICU) can develop stomach ulcers which are known as ‘stress ulcers’. ICU patients are routinely given two different types of medicine -proton pump inhibitors (PPI) and histamine H2 receptor blockers (H2RB), to prevent these ulcers, we did not know which treatment was best. This study compared the two most common standard treatments (PPI and H2RB)- in a cluster crossover study (where whole ICUs were randomly assigned to one treatment for 6 months, then swapped over to the other treatment). 3. Participant characteristics Patients from 50 ICUs in Australia, NZ, Canada, Ireland and United Kingdom participated. 13415 patients were assigned to the PPI group and 13356 patients were assigned to the H2RB group. 4. Key results The results found there was no statistically significant difference in mortality (death) 90 days after ICU admission, between the two groups of patients. Gut bleeding was lower in the PPI group of patient and there was no difference between the two groups for Clostridioides difficile infection or prolonged life support. 5. Limitations There was a large amount of cross-over between the 2 treatment arms of the study (PPI in the H2RB arm of the study and H2RB in the PPI arm) and doctors were allowed to use any type of PPI or H2RB and how they gave it. Doctors, nurses and research staff were aware of treatment assignment (unblinded) and individual-level drug data were not assessed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-13
• Study Completion: 2019-05-01
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26797

Inclusion Criteria

All patients aged 18 years or older who are mechanically ventilated within 24 hours of ICU admission.

Exclusion Criteria

Patients who are admitted to ICU with upper GI bleeding (APACHE III admission diagnostic codes 303, 305, and 1403)

Study & Design

• Study Type: Interventional
• Study Design: Not specified