The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Presence of Postoperative Delirium
研究概览
简要总结
The purpose of this study is to determine whether giving omega-3 fatty acids prior to and after cardiac bypass surgeries decreases the incidence of postoperative delirium in patients aged 65 and over.
详细描述
Patients aged 65 years and over requiring elective cardiac bypass surgeries will receive either 0, 2, or 4 grams of omega-3 ethyl esters before their surgery and for 3 days postoperatively to determine whether there is an affect on the incidence of postoperative delirium. All patients will receive hospital standard of care therapy for their surgery and hospital stay.
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
- None
盲法说明
This study will not be blinded as there is no suitable placebo for omega-3 ethyl esters available at this time.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •American Society of Anesthesiologists (ASA) Class Physical Status I-IV
排除标准
- •Inability to obtain written informed consent.
- •Inability to take study drug due to intubation or other reason.
- •Delirium present at screening.
- •Known hypersensitivity (e.g. anaphylactic reaction) to omega-3 ethyl esters or any of its components
- •Allergy to fish or shellfish
- •Currently taking warfarin (Coumadin), apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa/Lixiana), rivaroxaban (Xarelto), or other anticoagulant drugs.
- •Currently taking omega-3, omega-6, vitamin E, or fish oil supplements.
- •Significant renal disease with a serum creatinine ≥ 2 mg/dL.
- •Significant liver disease with alanine aminotransferase (ALT) levels 1.5 times the normal range of 6-45 units/liter and aspartate transferase (AST) levels 1.5 times the normal range of 10-42 units/liter.
- •History or diagnosis of diabetes.
- •History or diagnosis of neurodegenerative disease such as Parkinson's, Alzheimer's, or dementia.
- •History or diagnosis of bleeding disorder.
- •History or diagnosis of metabolic syndrome or disorder.
- •History or diagnosis of thyroid problems such as hyperthyroidism or hypothyroidism.
研究组 & 干预措施
Omega-3 Ethyl Esters 4 g
Patients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.
干预措施: Omega-3 Ethyl Esters 4 g (Drug)
Omega-3 Ethyl Esters 2 g
Patients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.
干预措施: Omega-3 Ethyl Esters 2 g (Drug)
Standard of Care
Patients will not receive any study drug.
结局指标
主要结局
Presence of Postoperative Delirium
时间窗: From the date of surgery until the patient is discharged, up to 30 days.
Number of patients that experienced postoperative delirium during the study.
次要结局
- Postoperative Delirium Symptoms(From the date of surgery until the patient is discharged, up to 30 days.)
- Length of Stay(From the date of surgery until the patient is discharged, up to 30 days.)
- Type of Anesthesia Used(During surgery, up to 24 hours)
- Amount of Pain Medication Given Postoperatively(From the date of surgery until the patient is discharged, up to 30 days.)
研究者
Quinn Johnson
Department Chair of Anesthesiology and Perioperative Medicine
University of Missouri-Columbia