Outcomes After Albumin vs Lactated Ringer's Solution in CABG and AVR Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
This is a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome.
详细描述
This will be a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome. Data will be collected from both EPIC and STS (society of thoracic surgeons) database. STS database extracts data from the electronic medical record and groups it in specific format to evaluate outcomes after cardiac surgery to compare institutional performance to similar institutions and the national average. Patients undergoing coronary artery bypass graft or aortic valve replacement will be randomized to receive either albumin or lactated Ringer's for fluid resuscitation post-surgery. The resuscitation volume will be based on clinical decision after examining all the hemodynamics parameters. This practice coincides with standard of care and current practice. All eligible patients will be randomly assigned to receive either albumin 5% or lactated Ringer's solution in a 1:1 ratio using computer-generated, permutated blocks of 2 - 4. Both solutions will be administered intravenously in 250 mL increments at the discretion of the physician until hemodynamic parameters are met. The IV infusion bag and IV tubing will be covered using opaque bags to allow for blinding.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients greater than 18 years of age undergoing CABG and AVR procedures
排除标准
- •Low ejection fraction (<20%) End stage renal disease Chronic renal insufficiency Pre-operative Inotropic (eg. Dobutamine) or vasoactive IV infusions (e.g, norepinephrine)
- •Jehovah's Witness Emergent surgery (e.g, intra-aortic balloon pump) Pre-operative acute kidney injury based on AKIN criteria Non English speaking patients
- •Jehovah's Witness population will be excluded regardless of their preference with accepting Albumin because sometimes PRBC are used as part of ongoing resuscitation in bleeding patients and if patients cannot use blood, this will have a much bigger issue with resuscitation and this study is not designed to follow up that population.
结局指标
主要结局
Acute Kidney Injury
时间窗: Within 72 hours post randomization
Acute kidney injury will be assessed by these criteria: Stage I. Increase 1.5-1.9 times from baseline or ≥ 0.3 mg/dl increase within 48 h. Urinary output (UOP) \< 0.5 ml/kg/h for 6-12 hours Stage II. Increase \> 2- to 3-fold from baseline. UOP \< 0.5 ml/kg/h for 12 hours Stage III. Increased \> 300% (\> 3-fold) from baseline, or ≥ 4.0 mg/dl with an acute increase of ≥ 0.5 mg/dl or on renal replacement therapy. UOP \< 0.3 ml/kg/h for 24 hours or anuria for 12 hours
次要结局
- Length of stay in the hospital(Up to 90 days)
- Extubation time(Up to 90 days)
- Length of stay in the ICU(Up to 90 days)
- Hospital readmission(Readmission within 30 days of discharge)