Modifying Delirium Using Simvastati

Not Applicable

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care; Mental and Behavioural Disorders; Postoperative delirium

• Registration Number: ISRCTN89079989
• Lead Sponsor: West Hertfordshire Hospitals NHS Trust (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25982544 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28734823

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-26
• Study Completion: 2015-01-31
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Patients requiring mechanical ventilation within 72 hours of admission to intensive care.
2. Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Age less than 18 years
2. Patient known to be pregnant
3. Known allergy to statin drugs
4. CK > 10 times upper limit of normal range
5. Alanine aminotransferase (ALT) >8 times the upper limit of normal range
6. Patients currently receiving ongoing and sustained treatment with any of the following; itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, cyclosporine, amiodarone, verapamil or diltiazem
7. Uncomplicated elective surgery
8. Patient expected to be discharged within 48 hours of admission
9. Patients with severe renal impairment (estimated creatinine clearance less than 30ml/minute) not receiving renal replacement therapy
10. Severe liver disease
11. Current or recent treatment (within 2 weeks) with statins
12. Physician decision that a statin is required for proven indication
13. Contraindication to enteral drug administration, e.g. patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded.
14. Known participation in investigational medicinal product (IMP) trials within 30 days
15. Consent declined
16. Treatment withdrawal likely within 48 hours
17. Non-English speaking patients or those who do not adequately understand verbal or written information

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alive, delirium free and coma free days; Timepoint(s): 14 days

Secondary Outcome Measures

Name	Time	Method
1. Incidence of delirium<br>2. Delirium/coma free days in first 28 days<br>3. Number of ventilator free days at 28 days<br>4. Length of critical care and hospital stay<br>5. Mortality at 6 months; (f) Organ failure free days<br>6. Cognitive Impairment at 6 months<br>7. Health related quality of life over the 6 month study period using the EQ-5D-5L<br>8. Quality adjusted life years at 6 months<br>9. Healthcare resource use and associated costs over the 6 month study period<br>10. Cost-effectiveness of the intervention at 6 months post-randomisation