Intranasal Insulin for the Prevention of Delirium in ICU Patients Undergoing Elective Cardiac Surgery: a Randomized, Double-blind, Placebo-controlled Pilot Trial (INSPIRE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility: rate of recruitment
研究概览
简要总结
This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age ≥65 years
- •Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG
- •Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
- •Informed consent from patient
排除标准
- •Delirium at hospital admission
- •Non-complex or off-pump cardiac surgery
- •Known allergy/hypersensitivity to insulin or formulation excipients
- •Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
- •Participating in other investigational medication trial
研究组 & 干预措施
Intranasal insulin
Intranasal insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day.
干预措施: Intranasal insulin-40U (Drug)
Intranasal placebo (NaCl 0.9%)
Intranasal placebo (sodium chloride 0.9%) administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4 mL per day.
干预措施: Intranasal sodium chloride 0.9% (Drug)
结局指标
主要结局
Feasibility: rate of recruitment
时间窗: From start of study to end of study, with a maximum of 12 months
Proportion of eligible patients who are enrolled and randomized during the recruitment period.
Feasibility: protocol adherence
时间窗: From start of treatment up to a maximum of 5 days
Number of administered doses divided by number of planned doses
Feasibility: participant retention and follow-up completeness
时间窗: From start of study to end of study, with a maximum of 12 months
Proportion of randomized participants completing in-hospital data collection and 30-day follow-up (TICS-m).
Tolerability
时间窗: From start of treatment up to a maximum of 5 days
\- Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia (mild: glucose \<4.1 mmol/L, severe: \<2.2 mmol/L), defined as the number of local nasal adverse events and hypoglycaemia events.
Exploratory efficacy
时间窗: From start of treatment up to a maximum of 7 days
Delirium severity as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98)
次要结局
- Delirium incidence(From start of treatment up to a maximum of 7 days)
- Delirium severity(From start of treatment up to a maximum of 7 days)
- Delirium duration(From start of treatment up to a maximum of 7 days)
- Delirium and coma-free days(From start of treatment up to a maximum of 7 days)
- Exposure to antipsychotics, sedatives and benzodiazepines(From start of treatment up to a maximum of 7 days)
- Length of ICU stay(From ICU admission to ICU discharge, assessed up to 6 months)
- Length of hospital stay(From hospital admission to discharge, assessed up to 6 months)
- Change in cognitive function(From informed consent to 30 days post-surgery)