The aim of this study is to assess whether citicoline (TRAUSAN), a neuroprotective agent involved in membrane phospholipid synthesis and neurotransmission, can prevent or attenuate cognitive decline in older adults who develop perioperative delirium during hospitalization for proximal hip fracture. Delirium is a frequent and severe complication in this population and is associated with cognitive and functional deterioration, institutionalization, and mortality. Participants will be randomly assigned (1:1) to receive citicoline 1000 mg/day for 6 months after discharge, or usual care. Cognitive and functional status will be evaluated at discharge and subsequently at 3 and 6 months follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
122
Citicoline acts as a neuroprotective agent by supporting membrane integrity, modulating neurotransmission, and reducing oxidative stress and neuronal damage, with potential benefits on cognitive and functional recovery. However, no previous trials has investigated the effect of citicoline in preventing cognitive decline after delirium. Participants in the experimental arm of this study will receive citicoline (TRAUSAN) 1000 mg/day as an oral solution in single-dose 10 mL sachets (100 mg/mL), starting the day after hospital discharge, for a total duration of 6 months. 1 mL of citicoline solution contains 100 mg of citicoline (as sodium salt). Excipient(s) with known effects: 1 mL of Citicoline oral solution contains 200 mg of liquid sorbitol, 10 mg of glycerin, 1.8 mg of methyl parahydroxybenzoate, 0.42 mg of propyl parahydroxybenzoate, 1.4 mg of potassium sorbate, 0.012 mg of Ponceau 4R red, and other excipients.
IRCCS San Gerardo dei Tintori Foundation
Monza, Monza E Brianza, Italy
RECRUITINGAssess potential differences in cognitive profiles 6 months post-randomization among older adults hospitalized for proximal hip fractures with perioperative delirium, comparing the intervention arm (citicoline,TRAUSAN) to the control arm
Montreal Cognitive Assessment (MoCA) performed at discharge and at 6 months post-randomization
Time frame: 6 months
Evaluate differences in cognitive profiles in older adults hospitalized for proximal hip fractures at 0 (discharge), 3, and 6 months after randomization, comparing the intervention (citicoline, TRAUSAN) to the control arm.
Montreal Cognitive Assessment (MoCA) performed at discharge and at 3 and 6 months post-randomization
Time frame: Discharge, 3 months, and 6 months
Evaluate differences in functional profiles from 3 to 6 months post-randomization between the intervention (citicoline, TRAUSAN) and control arm.
Short Physical Performance Battery (SPPB), performed at 3 and 6 months post-randomization
Time frame: 3 months and 6 months
Evaluate differences in adverse events between the intervention and control groups during the 6-month follow-up period post-randomization.
Rates of adverse events (quantity/seriousness) during the 6-months follow-up after randomization
Time frame: 6 months
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