CaffeinICU Study - A Multi-centre Pilot Study to Examine the Safety and Feasibility of Oral Caffeine in Critically Ill Adult Patients With Low Glasgow Coma Scale Score.
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Duration of mechanical ventilation
研究概览
简要总结
Background:
Depressed Glasgow Coma Scale (GCS) is common among critically ill patient s in the intensive care unit (ICU). It is one of the main reasons that hampers liberation from mechanical ventilation among ICU patients. Caffeine is commonly used in neonates for the treatment of apnea of prematurity. However, its efficacy has not been established in adult population.
Objective:
To find out the efficacy of oral caffeine in shortening duration of mechanical ventilation among adult patients.
Hypothesis:
Oral caffeine is effective as a central nervous system stimulant among adult patients with depressed GCS.
Study design:
Multi-center, randomised, double blind, placebo controlled clinical trial
Population:
Adult patients (≥ 21 years old) with GCS ≤ 8 from any causes (excluding surgically reversible causes) requiring continuation of mechanical ventilation, whom acute medical issues are stable or has resolved but not suitable for extubation solely due to depressed GCS, not planned for any surgical procedures within 24 hours and not on sedative agents for at least 24 hours, will be included in this study. For patients with primary Central Nervous System (CN lesions, neurologist or neurosurgeon approval will be obtained prior to recruitment. The exclusion criteria include known allergy or adverse reactions from caffeine, pregnant women, breast-feeding women, uncontrolled cardiac arrhythmias, uncontrolled hypertension, hyperactive delirium, patients with chronic kidney disease (CKD, any stage) who received midazolam or morphine infusion, patients who received barbiturate coma, patients who are on theophylline, aminophylline or psychotropic agents at the point of screening for recruitment, patients with feed intolerant, short bowel syndrome and active seizures.
Intervention:
Oral caffeine citrate 5mg/kg/dose twice a day (8am, 2pm) vs placebo
Outcomes:
Primary - Duration of mechanical ventilation Secondary - ICU mortality, 30-days mortality, ICU length of stay, blood pressure, heart rate, incidence of arrhythmia, GCS, incidence of re-intubation and need for tracheostomy
详细描述
Depressed Glasgow Coma Scale (GCS) is common among critically ill patients in the intensive care unit (ICU). It is one of the main reasons that hampers liberation from mechanical ventilation among ICU patients. Current management of this disorder focuses mainly on supportive care and treatment of the underlying disease. Directed therapies targeting neurochemical and neurotransmitter pathways are not currently available and it represents an important area of research. Caffeine is commonly used in neonates for the treatment of apnea of prematurity. It is a CNS stimulant that stimulates central respiratory drive, increases medullary respiratory center sensitivity to carbon dioxide and improves diaphragmatic contractility. However, its efficacy has not been established in adult population.
Hypothesis:
- Oral caffeine is safe for use for adult ICU patients with depressed GCS at the selected dose.
- It is feasible to recruit the stipulated study population from SGH and SKH within the time frame of the study.
Objective:
The primary objectives of the study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The study drug is oral caffeine solution which will be prepared by pharmacy laboratory using caffeine powder into 20mg/mL caffeine solution. The solution will be packed in amber glass bottle ready for administration by nurses at bedside without further dilution.
入排标准
- 年龄范围
- 21 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 21 years old),
- •Patients with encephalopathy (GCS ≤ 8) limiting extubation, where encephalopathy is deemed by clinician to be unresponsive to treatment or not eligible for treatment to reverse the encephalopathy (eg. transplantation) or if no treatment exists, and
- •Patients who are not planned for any surgical procedures within 24 hours
- •Patients who are not on sedative agents for at least 24 hours (exception for low dose fentanyl of up to 30mcg/h and dexmedetomidine of up to 0.5mcg/kg/h for analgesia/sedation/tube tolerance)
- •For patients with primary CNS lesions, neurologist or neurosurgeon approval will be obtained prior to recruitment.
排除标准
- •Known allergy or adverse reactions from caffeine,
- •Pregnant women,
- •Breast-feeding women,
- •Patients with uncontrolled cardiac arrhythmias,
- •Patients with uncontrolled hypertension,
- •Patients with hyperactive delirium,
- •Patients with chronic kidney disease (CKD, any stage) who received midazolam or morphine infusion during their ICU stay,
- •Patients who received barbiturate coma,
- •Patients who are on theophylline, aminophylline or psychotropic agents at the point of screening for recruitment,
- •Patients with feed intolerant, short bowel syndrome, or
- •Patients with active seizures
研究组 & 干预措施
Oral caffeine group
Patients in this arm will receive treatment with oral caffeine
干预措施: Caffeine Citrate 20 MG/ML Oral Solution (Drug)
结局指标
主要结局
Duration of mechanical ventilation
时间窗: From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier
Duration of mechanical ventilation in days
次要结局
- 30-days mortality(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- ICU mortality(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- Incidence of terminal extubation(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- Blood pressure(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- GCS(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- Incidence of re-intubation(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- ICU length of stay(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- Heart rate(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- Incidence of arrhythmia(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)
- Need for tracheostomy(From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier)