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

Phase 4

Completed

• Conditions: Gastrointestinal Bleeding; Critical Illness; Ventilator-associated Pneumonia; Clostridium difficile infection; Metabolic and Endocrine - Other metabolic disorders; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12613000807752
• Lead Sponsor: Dr Adam Deane

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified