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临床试验/NCT04876742
NCT04876742招募中不适用

A Randomised Placebo-controlled Double-blind Exploratory Trial Within Cohort Using Wheat Beer for Prevention of Delirium in Intensive Care Patients

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2023年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
380
试验地点
2
主要终点
Development of delirium

研究概览

简要总结

The investigators hypothesise that the daily administration of 0.5L alcohol-containing wheat beer at 8 pm over a study period of 6 days in a row leads to a lower prevalence of delirium compared to water following the same administration scheme.

详细描述

Delirium

Delirium is a complex state of confusion that can be seen as an acute failure of brain function. It is characterised by fluctuating deficits in cognition and attention, dysregulation of emotions and circadian rhythm as well as psychomotor changes.

In intensive care units (ICU) delirium is the most frequent syndromic complication with a prevalence between 26 - 60%. In mechanically ventilated patients, delirium is even detected in more than 80%. In elective cardiac surgery patients admitted to the ICU for postoperative monitoring postoperative delirium presents as a major complication and occurs in up to 33.5%. Hypoactive delirium outperforms the other two types - hyperactive and mixed - by far.

Occurrence of delirium is associated with several negative repercussions: Delirious patients show higher prevalence in morbidity and mortality, longer stays in intensive care units and the regular ward, as well as impaired cognitive function even months after the acute illness. The intensity of impairment in cognitive and executive function correlates with the duration of delirium. Furthermore, delirious patients cause major additional costs of up to 20% more compared to non-delirious patients.

Although there are several approaches for prevention of deliria in ICUs they are still highly prevalent causing a high and versatile burden as mentioned above. The several mainly pharmacological treatment approaches are more to be seen as a symptomatic treatment than a causal treatment. No groundbreaking prevention or treatment strategy has been found so far. Therefore, improvement of existing and development of new prevention strategies is therefore crucial and highly necessary. Further it has to be shown if prevention of delirium has an effect on clinical outcome.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Patients meeting the following criteria are eligible for the study:
  • Risk of delirium: ICU patients with expected length of stay (LOS) ≥ 24 hours
  • Naso-gastric tube in situ
  • ICU stay ≤ 72h until first study intervention
  • Women: negative pregnancy test, age ≥50 years or status post hysterectomy/bilateral ovariectomy
  • Adult patients (age ≥ 18 years)
  • ≥ 50 kg body weight or BMI ≥18.5

排除标准

  • Patients fulfilling the following criteria are excluded from the study:
  • Pre-existing liver pathologies
  • Patients after bone marrow transplantation
  • Women: breastfeeding
  • Pre-existing delirium (ICDSC ≥ 4)
  • Terminal state
  • Active psychosis
  • Anamnestic complete alcohol abstinence or status post alcohol abuse
  • Especially vulnerable patients
  • Allergy to any ingredient(s) of beer

研究组 & 干预措施

0.5 liters of alcoholic beer

Experimental

干预措施: Beer (Other)

non-interventional cohort control group

No Intervention

0.5 liters of water

Placebo Comparator

干预措施: Water (Other)

结局指标

主要结局

Development of delirium

时间窗: 7 days

Development of delirium until day 7 after enrolment

次要结局

  • Delirium-free days(30 days)
  • Sedation-free days(30 days)
  • Agitation-free days(30 days)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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