CompletedPhase 4ACTRN12613000807752

The effect of routine pantoprazole administration when compared to placebo on gastrointestinal bleeding, ventilator-associated pneumonia and Clostridium difficile infection in enterally-fed mechanically ventilated critically ill patients: A prospective randomised study


Sponsor

Dr Adam Deane

Enrollment

500 participants

Start Date

Jan 28, 2014

Study Type

Interventional

Conditions

Summary

To evaluate whether routine administration of proton pump inhibitor (intravenous pantoprazole) to mechanically-ventilated critically ill patients: (1) Reduces the incidence and severity of gastrointestinal bleeding; and (2) Increases the incidence of ventilator-associated pneumonia and/or Clostridium difficile infection


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Consecutive patients admitted to the ICU at the RAH who are anticipated to remain mechanically ventilated for > 24 hours AND receive enteral nutrition within 48 hours of admission

Exclusion Criteria11

  • Current (prior to hospital admission) use of proton pump inhibitor or histamine-2 receptor blocker drugs
  • Pregnancy
  • Patients admitted with suspected or proven gastrointestinal bleeding
  • Patients with a history of proven peptic ulcer disease
  • Patients receiving > 400 mg/day of hydrocortisone (or equivalent of prednisolone (100mg) or dexamethasone (15mg))
  • History of surgery on the oesophagus, stomach or duodenum during the current hospital admission
  • Patients where the treating consultant intensive care physician believes that stress ulcer prophylaxis is either clearly indicated or contraindicated
  • Patients who are Jehovah’s Witnesses
  • Patients who do not receive their first dose of study medication within 36 hours of initiation of mechanical ventilation (this criterion is required to avoid contamination of cohorts as if stress ulcer prophylaxis is beneficial it is likely to be of benefit when commenced as early as possible and patients who have been ventilated at another hospital for > 24 hours may have received stress ulcer prophylaxis).
  • Patients admitted for palliative care.
  • Patients readmitted to the Intensive Care Unit

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Interventions

This will be a randomised double-blind parallel study comparing 40mg IV pantoprazole daily to placebo in mechanically-ventilated critically ill patients receiving enteral nutrition for up to a maximum

This will be a randomised double-blind parallel study comparing 40mg IV pantoprazole daily to placebo in mechanically-ventilated critically ill patients receiving enteral nutrition for up to a maximum of 14 days


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12613000807752


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