Lactated Ringer's Versus 5% Human Albumin: Cardiac Surgical Patients
Condition: Hemodynamic Stability
Intervention: Lactated Ringer's; 5% Human Albumin
Intervention description: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.; Colloid given for hemodynamic resuscitation based off of individual patient needs.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Lactated Ringer's; Human Albumin

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.
    

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

          -  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.