Lactated Ringer's Versus 5% Human Albumin: A Double-Blinded, Randomized, Prospective Study in Cardiac Surgical Patients
Overview
- Phase
- Phase 2
- Intervention
- Lactated Ringer's
- Conditions
- Hemodynamic Stability
- Sponsor
- William C. Oliver
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Total Fluid Administered Indexed to Weight
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
William C. Oliver
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Non-pregnant female patients
- •Patients undergoing elective cardiac surgery
- •Aspirin, heparin, or warfarin preoperatively accepted
Exclusion Criteria
- •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
Arms & Interventions
Lactated Ringer's
Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.
Intervention: Lactated Ringer's
5% Human Albumin
Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.
Intervention: 5% Human Albumin
Outcomes
Primary Outcomes
Total Fluid Administered Indexed to Weight
Time Frame: 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.
Secondary Outcomes
- Alveolar-arterial Gradient(Calculated throughout the study up to 6 hours in the ICU)