PEPTIC v1.0

  • Research type

    Research Study

  • Full title

    Proton Pump Inhibitors vs. Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) study: A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors vs. histamine-2 receptor blockers for ulcer prophylaxis therapy in the Intensive Care Unit

  • IRAS ID

    224703

  • Contact name

    Stephen Wright

  • Contact email

    stephen.wright@nuth.nhs.uk

  • Sponsor organisation

    Medical Research Institute of New Zealand

  • Clinicaltrials.gov Identifier

    12616000481471, ANZCTR

  • Duration of Study in the UK

    1 years, 5 months, 1 days

  • Research summary

    Patients who require treatment in the Intensive Care Unit (ICU) can develop stomach ulcers or duodenal (small intestine) ulcers, these kinds of ulcers are known as ‘stress ulcers ’and may cause life threatening bleeding; this occurs most commonly when mechanical ventilation (a breathing machine) is required. To prevent this, mechanically-ventilated patients in the ICU are frequently given stress ulcer prophylaxis (SUP) in the form of one of two types of medicine: proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs).

    Despite SUP being administered to millions of ICU patients worldwide, it is unclear where PPIs or H2RBs are preferable and current usage is dependent on clinician preference or unit policy rather than empirical evidence.

    The PEPTIC study will compare the two approaches to SUP treatment regimens to determine which leads to the best outcomes for patients. The study is being conducted in New Zealand, Australia, Ireland and England. Data will be collected on patients admitted to ICUs requiring mechanical ventilation where SUP is considered clinically appropriate. Data required for the study is already routinely recorded in ICUs – in England, this will be collected through the ICNARC Case Mix Programme (CMP).

  • REC name

    London - Bromley Research Ethics Committee

  • REC reference

    17/LO/1313

  • Date of REC Opinion

    1 Sep 2017

  • REC opinion

    Favourable Opinion