Sepsis & infection

Pantoprazole Use in Invasively Ventilated Patients With Septic Shock: A Protocol and Statistical Analysis Plan

Acta Anaesthesiol ScandPublished Protocol and statistical analysis plan for a post hoc subgroup analysis of the REVISE randomised trial

Study context

Population
Invasively ventilated critically ill adults with septic shock (vasopressors or inotropes at baseline plus admitting diagnosis of infection by APACHE III categories) enrolled in REVISEREVISE enrolled 4821 in 68 ICUs
Planned comparison
IV pantoprazole 40 mg once daily vs placebo
Primary endpoint
Clinically important upper gastrointestinal bleeding in the ICU (primary safety outcome: all-cause mortality within 90 days)
Follow-up
90 days after randomization
Methodological detailspost hoc extended subgroup analysis, international, blinded, randomized, Analyses adjusted for prehospital acid suppression; mortality analyses additionally adjusted for APACHE II score
  • Post hoc extended subgroup analysis
  • International
  • Blinded
  • Randomized
  • Analyses adjusted for prehospital acid suppression; mortality analyses additionally adjusted for APACHE II score

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Pantoprazole Use in Invasively Ventilated Patients With Septic Shock: A Protocol and Statistical Analysis Plan. Acta Anaesthesiol Scand. Published 26 May 2026. doi:10.1111/aas.70267

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