Lactated Ringer's Versus 5% Human Albumin: A Double-Blinded, Randomized, Prospective Study in Cardiac Surgical Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Total Fluid Administered Indexed to Weight
研究概览
简要总结
The purpose of this study is to show which of two different types of fluid is best for cardiac surgical patients. During and after the subject's heart surgery, the subject will be given either Lactated Ringer's or 5% human albumin to replace lost blood and body fluids and to regulate blood pressure.
Albumin (human) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of Albumin (human) 5% are provided by FDA approved blood establishments only.
Lactated Ringer's is a sterile, nonpyrogenic solution containing isotonic concentrations of electrolytes in water for injection. It is FDA approved for administration by intravenous infusion for parental replacement of extracellular losses of fluid and electrolytes.
The hypothesis of this study is that the individual total fluid volume and alveolar-arterial gradient will be less with 5% human albumin compared to Lactated Ringer's in the perioperative cardiac surgical patient.
详细描述
Following Institutional Review Board (IRB) approval and written informed patient consent, 40 elective, cardiac surgical patients will be randomized to two different fluid therapy regimens, 5% human albumin only or Lactated Ringer's only, beginning in the intraoperative period and up to 6 hours in the intensive care unit. Providers and patients will be blinded to the fluid administered in the operating room and intensive care unit. The primary outcome measure will be the total volume of 5% human albumin or Lactated Ringer's given during the study period to maintain specified hemodynamic guidelines. Hemodynamic instability will be defined according to each patient's stipulated baseline parameters. Fluid will be administered at the request of providers in the operating room and intensive care unit in compliance with a perioperative fluid algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant female patients
- •Patients undergoing elective cardiac surgery
- •Aspirin, heparin, or warfarin preoperatively accepted
排除标准
- •Previous sternotomy
- •Emergency surgery
- •Combined procedures (vascular or thoracic operations)
- •Congenital heart repair
- •Hypothermic cardiopulmonary bypass (CPB) < 28 degrees C
- •Serum creatinine greater than or equal to 1.5 mg/dL
- •Dialysis dependent renal failure
- •Neurologic injury or event within 30 days (including transient ischemic attack)
- •Cerebrovascular accident with significant residual neurologic deficit
- •Severe chronic obstructive pulmonary disease with Forced Expiratory Volume in 1 Second (FEV1) < 45% of predicted value
- •Home oxygen use
- •Previous difficult intubation
- •Acute normovolemic blood conservation techniques
- •Liver disease with serum aspartate aminotransferase (AST) > 31 U/L
- •Circulatory arrest
- •Thrombolysis
- •Pre-existing clotting disorder
- •Platelet receptor glycoprotein IIb/IIIa (GP IIb/IIIa) antagonist medication received within 48 hours
- •Ejection Fraction < 40%
- •Intra-aortic balloon pumps
- •Ongoing congestive heart failure
- •Ventricular assist devices
- •Total hearts
- •Pregnant women
- •Adults lacking capacity to consent
- •Any patients initially enrolled in the study that end up with an intra-aortic balloon pump, left ventricular assist device, or on extracorporeal membrane oxygenation will be eliminated from the study.
研究组 & 干预措施
Lactated Ringer's
Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.
干预措施: Lactated Ringer's (Drug)
5% Human Albumin
Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.
干预措施: 5% Human Albumin (Drug)
结局指标
主要结局
Total Fluid Administered Indexed to Weight
时间窗: Start of surgery up to 6 hours into the intensive care unit (ICU)
Adequate fluid volume plays a major part in maintaining the necessary hemodynamics to prevent organ damage during cardiac surgery. This will be measured by the total volume of fluid administered to the subject from the start of surgery up to 6 hours in the intensive care unit.
次要结局
- Alveolar-arterial Gradient(Calculated throughout the study up to 6 hours in the ICU)
研究者
William C. Oliver
Principal Investigator
Mayo Clinic