Lactated Ringer's Versus 5% Human Albumin: Cardiac Surgical Patients

Phase 2

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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
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
Steroids
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.

Arm && Interventions

Group	Intervention	Description
Lactated Ringer's	Lactated Ringer's	Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.
5% Human Albumin	5% Human Albumin	Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.

Primary Outcome Measures

Name	Time	Method
Total Fluid Administered Indexed to Weight	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 Outcome Measures

Name	Time	Method
Alveolar-arterial Gradient	Calculated throughout the study up to 6 hours in the ICU	Alveolar-arterial gradient will be calculated from arterial blood gases on each patient. This value will be used to compare shunt in each arm.