Testing if simvastatin reduces delirium - acute confusion - in intensive care patients.

Phase 1

• Conditions: Delirium; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003114-13-GB
• Lead Sponsor: West Hertfordshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-06
• Study Completion: 2017-01-11
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 142

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified