Trial Acronym MoDUS
Clinical Area Critical Care
Description Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in mechanically ventilated patients at high risk of delirium.
Status Closed
Date Opened to Recruitment February 13
Target Recruitment 142
Recruitment to date 142
Date Closed to Recruitment July 2016
Trial Design Prospective randomised double-blind, placebo-controlled phase II single-centre trial of Simvastatin for the prevention/treatment of delirium.
Study Aim The aim of this trial is to test the hypothesis that statins, which are known to have several potent anti-inflammatory effects and are considered responsible for health benefits seen beyond their simple cholesterol lowering ability, may also prevent delirium in critically ill patients. The study has three distinct objectives:
  1. To investigate the efficacy of statins initiated early during an ICU stay for the prevention of ICU delirium.
  2. To determine any improvement in related neurocognitive sequelae coupled with standard clinical outcomes.
  3. To study the biological effect of Simvastatin on systemic markers of inflammation as related to the number of delirium/coma free days and the potential of B-amyloid as a predictor of the risk of long term cognitive impairment.
Chief Investigator Dr Valerie Page
Sponsor West Hertfordshire Hospitals NHS Trust
Funder NIHR Research for Patient Benefit (RfPB)