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

William C. Oliver

Status and phase

Terminated

Phase 2

Conditions

Hemodynamic Stability

Treatments

Drug: 5% Human Albumin

Drug: Lactated Ringer's

Study type

Interventional

Funder types

Other

Identifiers

NCT02654782

15-000858

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.