Delirium
Conditions
Interventions
Product Name: Simvastatin
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
CAS Number: 79902-63-9
Concentration unit: mg/g m
Sponsors
West Hertfordshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients requiring mechanical ventilation within 72 hours of admission to intensive care. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Age less than 18 years Patient known to be pregnant Known allergy to statin drugs CK > 10 times upper limit of normal range Alanine aminotransferase (ALT) >8 times the upper limit of normal range Patients currently receiving ongoing and sustained treatment with any of the following; itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, cyclosporine, amiodarone, verapamil or diltiazem Uncomplicated elective surgery Patient expected to be discharged within 48 hours of admission Patients with severe renal impairment (estimated creatinine clearance less than 15ml/minute) not receiving renal replacement therapy Severe liver disease Current or recent treatment (within 2 weeks) with statins Physician decision that a statin is required for proven indication Contraindication to enteral drug administration, e.g. patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded. Known participation in investigational medicinal product (IMP) trials within 30 days Consent declined Treatment withdrawal likely within 48 hours Non-English speaking patients or those who do not adequately understand verbal or written information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Knowing that critically ill patients who need to be on ventilators are at high risk of delirium , does giving them simvastatin decrease the length of time they are delirious for?; Secondary Objective: The secondary aims of this study are 1) to examine other important clinical outcomes i.e.the number of patients who become delirious, how many die, how long they are in hospital for, brain function at 6 months, quality of life after discharge, safety and cost-effectiveness 2) to assess the potential of plasma beta amyloid 42/40 levels as a predictor of the risk of developing cognitive impairment after an episode of delirium. 3) see if statins decrease inflammation associated with delirium by a series of blood tests looking for substances that increase when a patient has general inflammation. 4) look for evidence of changes in the brain chemistry in patients who have delirium - low cholinergic levels - by looking for levels of the same substance in the blood. ;Primary end point(s): Delirium/coma free days at 14 days. | — |
Countries
United Kingdom
Contacts
Public ContactIntensive Care
West Hertfordshire Hospitals NHS Trust
Outcome results
None listed