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临床试验/CTRI/2025/05/087534
CTRI/2025/05/087534
尚未招募
4 期

Efficacy of Intranasal Insulin in the prophylaxis of ICU Delirium: A Single center double blined prospective randomized trial

DrMeghna Kahlon1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年10月6日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
DrMeghna Kahlon
入组人数
66
试验地点
1
主要终点
Incidence of delirium

概览

简要总结

Delirium is a sudden and severe state of confusion characterized by fluctuating disruptions in cognitive function and attention.The prevalence of delirium varies widely in the intensive care unit affecting 11% and 83% of patients. Its occurence is associated with increased mortality and prolonged ICU stays.Prevention and management remains a tough problem because of side effects and limited effiacy of treatment options.No evidence based pharmacological therapies have been proven efficacious in treatment of delirium.

Intranasal insulin has recently emerged as a promising approach for preventing and treating perioperative neurocognitive disorders, showing effectiveness without reported side effects. Intranasal insulin administration at doses of 160 units has demonstrated improvements in memory function and brain metabolism in patients with cognitive dysfunction and delirium without causing hypoglycemia. it bypasses the blood brain barrier and elevates insulin levels in the cerebrospinal fluid without entering the bloodstream or causing systemic metabolic effects.

The replicability and applicability of these proposed benefits of intranasal insulin is still unclear in critical care.in this study, we try to answer if intranasal insulin reduces the prevalence of delirium in a population of critically ill patients compared with usual care

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Both male and female aged 18-70 years with expected ICU stay of more than 24 hours.

排除标准

  • Already delirious or pre-existing cognitive dysfunction Pregnant patients Patients with irreversible brain damage or acute brain injury Hepatic encephalopathy or liver cirrhosis with a Child Pugh Score B or C Comatose patients who cannot be assessed for delirium Patients in whom intranasal drug administration is contraindicated Patients with hypoglyceamia at the tme of presentation RASS -4 OR -5.

结局指标

主要结局

Incidence of delirium

时间窗: Within the first 10 ICU days

次要结局

  • The number of positive CAM-ICU counts(Duration of delirium)

研究者

发起方
DrMeghna Kahlon
申办方类型
Other []

研究点 (1)

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