None listed
Conditions
Brief 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
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 of 14 days
Sponsors
Dr Adam Deane
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
1. Current (prior to hospital admission) use of proton pump inhibitor or histamine-2 receptor blocker drugs 2. Pregnancy 3. Patients admitted with suspected or proven gastrointestinal bleeding 4. Patients with a history of proven peptic ulcer disease 5. Patients receiving > 400 mg/day of hydrocortisone (or equivalent of prednisolone (100mg) or dexamethasone (15mg)) 6. History of surgery on the oesophagus, stomach or duodenum during the current hospital admission 7. Patients where the treating consultant intensive care physician believes that stress ulcer prophylaxis is either clearly indicated or contraindicated 8. Patients who are Jehovah’s Witnesses 9. 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). 10. Patients admitted for palliative care. 11. Patients readmitted to the Intensive Care Unit
Outcome results
None listed