Comparing the efficacy of vitamin B12 and vitamin D supplementation versus placebo in the prevention of delirium in critically ill patients:A Prospective Randomized Controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Delirium is a transient acute neuropsychiatric disorder characterized by altered consciousness impaired attention and cognitive dysfunction and is common among critically ill patients admitted to the intensive care unit. The incidence of delirium in the intensive care unit is high and is associated with increased morbidity mortality and prolonged hospital stay. Several modifiable and non modifiable risk factors contribute to the development of delirium including malnutrition and vitamin deficiencies.
This study is a prospective randomized controlled trial designed to evaluate whether supplementation with vitamin B12 and vitamin D reduces the incidence of delirium in critically ill patients. Eligible patients admitted to the intensive care unit will be enrolled after obtaining informed consent from the patient or legally authorized representative. Participants will be randomly allocated into two groups using a computer generated randomization sequence with allocation concealment by sealed opaque envelopes.
Patients in the intervention group will receive vitamin B12 and vitamin D supplementation in addition to standard intensive care treatment. Patients in the control group will receive placebo along with standard intensive care treatment including nutrition and multivitamin supplementation as per intensive care unit protocol. Delirium will be assessed using standardized clinical tools during the intensive care unit stay.
The primary outcome of the study is the incidence of delirium during intensive care unit stay. Secondary outcomes include serum levels of vitamin B12 and vitamin D duration of intensive care unit stay number of delirium free days cognitive function at intensive care unit discharge and quality of life at hospital discharge. This study aims to evaluate a simple and potentially cost effective strategy for the prevention of delirium in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged twenty five to seventy five years admitted to the ICU.
- •Patients with a Glasgow Coma Scale score of eight or above and a Richmond Agitation Sedation Scale score minus three or above.
- •Patients are expected to stay in the ICU for at least forty eight hours.
排除标准
- •Patients refused to participate in the study.
- •Patients aged below twenty five years or above seventy five years.
- •Patients with a Glasgow Coma Scale score below eight or a Richmond Agitation Sedation Scale score below minus three.
- •Patients with traumatic brain injury.
- •Patients with severe septic shock and multi-organ dysfunction.
研究者
Chethan V
All India Institute of Medical Sciences, Jodhpur