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
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 1) Feasibility, 2) tolerability and 3) exploratory efficacy, defined as: 1) Recruitment rate, protocol adherence (number of administered doses divided by number of planned doses), participant retention, follow-up completeness and effectiveness of blinding; 2) Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia, defined as the number of local nasal adverse events and hypoglycaemia events; 3) Delirium severity (DRS-R-98)
研究概览
简要总结
This study aims to assess the feasibility, tolerability, and preliminary exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 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 surgery is defined as: combined procedures (e.g., multi-vessel CABG or single CABG + valve replace-ment/repair); or aortic surgery (ascending aorta, arch, or root) or repair of aortic dissection; or expected CPB duration ≥ 90 minutes, as estimated preoperatively
- •Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
- •Informed consent from patient
排除标准
- •Delirium or dementia present at baseline
- •Single-vessel CABG, single valve replacement/repair or off-pump cardiac surgery
- •Known allergy/hypersensitivity to insulin or formulation excipients
- •Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus sur-gery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
研究组 & 干预措施
Natriumchloride 0,9% oplossing voor injectie
干预措施: Natriumchloride 0,9% oplossing voor injectie (Drug)
Insulatard 100 international units/ml suspension for injection in vial.
干预措施: Insulatard 100 international units/ml suspension for injection in vial. (Drug)
结局指标
主要结局
1) Feasibility, 2) tolerability and 3) exploratory efficacy, defined as: 1) Recruitment rate, protocol adherence (number of administered doses divided by number of planned doses), participant retention, follow-up completeness and effectiveness of blinding; 2) Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia, defined as the number of local nasal adverse events and hypoglycaemia events; 3) Delirium severity (DRS-R-98)
1) Feasibility, 2) tolerability and 3) exploratory efficacy, defined as: 1) Recruitment rate, protocol adherence (number of administered doses divided by number of planned doses), participant retention, follow-up completeness and effectiveness of blinding; 2) Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia, defined as the number of local nasal adverse events and hypoglycaemia events; 3) Delirium severity (DRS-R-98)
次要结局
- Delirium incidence, dichotomous, defined as >= 1 positive delirium assessment(s)
- Delirium duration, defined as number of days with positive delirium assessment
- Delirium and coma-free days, defined as number of days without delirium or coma
- Antipsychotic, sedative and benzodiazepine exposure, defined as number of patients receiving antipsychotics, sedatives, or benzodiazepines.
- Length of ICU and hospital stay, defined as days spent in ICU and hospital
- Change in cognitive function, assessed with the modified Telephone Interview for Cognitive Status (TICS m) at baseline (2 weeks prior to hospital admission) and 30 days after surgery
研究者
Mark van den Boogaard
Scientific
Radboud universitair medisch centrum Stichting