MoDUS

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

RECRUITMENT

Date Opened to Recruitment	February 13
Target Recruitment	142
Recruitment to date	142
Date Closed to Recruitment	July 2016

TRIAL DESIGN

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 (CI)

Chief Investigator

Dr Valerie Page

SPONSOR(s) & FUNDER(s)

Sponsor	West Hertfordshire Hospitals NHS Trust
Funder	NIHR Research for Patient Benefit (RfPB)