A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Duration of Post-operative Delirium
研究概览
简要总结
Post-operative delirium is a common and deleterious complication in elderly patients. The investigators have previously found lower levels of serum tryptophan in post-operative elderly patients who developed delirium in comparison to post-operative elderly patients who did not develop delirium. The investigators hypothesize that post-operative supplementation of L-tryptophan will reduce the duration and incidence of post-operative delirium. This study is a double-blinded placebo controlled trial of L-tryptophan supplementation in post-operative ICU patients 60 years and older. The primary outcome measure is the comparison of duration of post-operative delirium in subjects who receive L-tryptophan supplementation versus a similar appearing control.
详细描述
The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included subjects will be 60 years and older undergoing an operation with a planned ICU admission post-operatively.
排除标准
- •Medications that, when combined with tryptophan, increase the risk of serotonin syndrome. The classes of medications include:
- •monoamine oxidase inhibitors
- •selective serotonin reuptake inhibitors
- •serotonin-norepinephrine reuptake inhibitors
- •central nervous system stimulants
- •bupropion
- •St. John's Wort
- •Patients who undergo an operation on their brain.
- •Factors which prevent delirium assessment with the CAM-ICU: vision impairment or non-fluent English speakers.
- •A lowered seizure threshold including:
- •history of seizure disorder
- •alcohol abuse defined by a high AUDIT score (>8 females and >13 males)
- •benzodiazepine or barbiturate abuse within three months of the study
- •OR a positive urine toxicology screen for alcohol, benzodiazepines or barbiturates.
- •Significant liver disease (Child's class B or greater) or significant renal disease (Creatinine ≥2.0).
- •History of Huntington's or Addison's disease. (As requested by the FDA)
- •History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia). (As requested by the FDA)
- •Women who are not post-menopausal. (As requested by the FDA)
研究组 & 干预措施
L-Tryptophan
L-tryptophan supplementation (1 gram enterally three times per day) starting post-operatively and continuing for a maximum of 9 doses or the time of discharge from ICU (whichever occurs first)
干预措施: L-tryptophan supplementation (Drug)
Placebo
Similar appearing placebo administered post-operatively (1 enterally three times per day) for a total of nine doses or discharge from ICU (whichever occurs first)
干预措施: L-tryptophan supplementation (Drug)
Placebo
Similar appearing placebo administered post-operatively (1 enterally three times per day) for a total of nine doses or discharge from ICU (whichever occurs first)
干预措施: placebo (Drug)
结局指标
主要结局
Duration of Post-operative Delirium
时间窗: post-operatively daily in ICU until discharged from ICU
次要结局
- Incidence of Post-operative Delirium(post-operatively daily in ICU until discharged from ICU)
- Level of Post-operative Serum Tryptophan(post-operative day number two blood draw)
- Level of Post-operative Melatonin(Blood draw on post-operative day number two)
- Length of Post-operative ICU and Hospital Stay(length of post-op hospital stay)