Diaz 2001.
| Methods | Design: Randomised controlled study of citicoline in hip fracture surgery patients Date of study: Study dates not reported Power calculation: Yes, indicates 88 patients needed, but results for 81 given Frequency of outcomes assessment: Immediately and on days 1, 2 and 3 postoperatively Inclusion criteria: 70 years or over, admitted with hip fracture Exclusion criteria: Organic brain disorder, major cerebrovascular disease, anaesthetic risk ASA IV |
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| Participants | Number in study: 81 Country: Chile Setting: Multi‐centre orthopaedic or trauma departments Age mean years (SD): Citicoline 79.5 (6.6), Control 80.0 (5.9) P = 0.9 Sex M:F: Citicoline 4/31, Control 10/36; P = 0.2 Co‐morbidity: Specific conditions not described. Present in 28/35 in intervention group and 39/46 in control group Dementia: Excluded |
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| Interventions | Intervention: Citicoline 400 mg orally 8 hourly, given between 24 hrs before and 4 days after surgery (n = 35). Control: Placebo matched for colour, consistency and flavour (n = 46) If anticholinergics and benzodiazepines were being used they were stopped, and anaemia and haemodynamic variables corrected in both groups | |
| Outcomes | 1. Incident delirium immediately, day 1, day 2 and day 3 postoperatively using MMSE, AMT, CAM 2. Cognitive status, using MMSE | |
| Notes | Funding source: Not reported Declarations of interest: Not reported Delirium excluded at enrolment using MMSE, AMT, CAM Study underpowered, as incidence of delirium much lower than the 20% used in power calculation |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Carried out and codes kept by hospital pharmacy independently of researchers |
| Random sequence generation (selection bias) | Low risk | 'Lottery drawing' independently of researchers |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Matched placebo used |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors blind to allocation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Sample size reported but unclear how many randomised |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information presented to make judgment |
| Other bias | Low risk | No evidence of other bias |