Effectiveness of CITicoline (TRAUSAN) in Preventing Cognitive Decline After DELirium in Older Adults With Proximal Hip Fracture - The CITADEL Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Assess 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged ≥65 who were admitted for a proximal hip fracture to the Orthogeriatric Unit and underwent hip fracture surgery (IRCCS San Gerardo dei Tintori Foundation, Monza)
- •Clinical diagnosis of delirium (arising from any cause), ascertained pre- or post-operatively using the 4AT score (cut-off ≥ 4/12)
- •Diagnosis of chronic vascular encephalopathy (corroborated by clinical documentation or previous cerebral imaging), i.e. evidence of neurological and cognitive disorder resulting from cerebrovascular accidents
- •Prognosis quoad vitam ≥ 3 months
- •Availability of a formal or informal caregiver who may help the participant to take the prescribed dose and follow the visit schedule
- •Informed consent, freely granted from the participant or from his/her legal guardian (or from an impartial witness in cases where the patient is unable to sign but clearly expresses the will to participate), and acquired before the randomization.
排除标准
- •Diagnosis of severe dementia (defined by medical clinical records or by the presence of an AD8 score ≥6 and a Global Deterioration Scale score ≥6)
- •Current therapy with citicoline
- •Any contraindications to citicoline (TRAUSAN), including allergy to acetylsalicylic acid or excipients contained in the drug, previous adverse reactions to citicoline, hypertonia of the parasympathetic nervous system, low-sodium diet
- •Clinical conditions or situations other than the condition being studied, which in the opinion of the researchers could interfere with the study or not allow optimal participation
- •Persistent in-hospital delirium (≥ 6 days or still present 24 hours prior to discharge).
研究组 & 干预措施
Experimental: Citicoline Intervention Group
Participants randomized to the experimental arm will be administered Citicoline (TRAUSAN) at 1000 mg/day as an oral solution in single-dose 10 mL sachets (100 mg/mL), starting the day after hospital discharge and continued for 6 months (participants will receive a 3-month supply at enrollment and a further 3-month supply at the scheduled 3-month follow-up visit).
Study drug accountability will be maintained through tracking of dispensed and returned sachets at follow-up visits.
Participants will document daily intake, missed doses, treatment deviations, adverse events, and any changes in concomitant therapies in a diary (with the help of their caregivers), which will be reviewed at follow-up visits.
干预措施: Citicoline (Drug)
No Intervention: Control Group
The control group will not receive any specific pharmacological treatment for cognitive decline prevention after delirium.
Non-pharmacological interventions, such as those suggested by the HELP program to prevent delirium during hospitalization, will be equally provided in both the intervention and control groups as part of the in-hospital usual clinical care in all patients.
结局指标
主要结局
Assess 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
时间窗: 6 months
Montreal Cognitive Assessment (MoCA) performed at discharge and at 6 months post-randomization
次要结局
- 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.(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.(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.(6 months)