Clinical trial NCT02654782: Lactated Ringer's Versus 5% Human Albumin: Cardiac Surgical Patients
Official title: Lactated Ringer's Versus 5% Human Albumin: A Double-Blinded, Randomized, Prospective Study in Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hemodynamic Stability
Keywords: Lactated Ringer's
Human Albumin
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total Fluid Administered Indexed to Weight
timeFrame: Start of surgery up to 6 hours into the intensive care unit (ICU)
Secondary outcomes:
measure: Alveolar-arterial Gradient
timeFrame: Calculated throughout the study up to 6 hours in the ICU
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: William Oliver, MD
role: PRINCIPAL_INVESTIGATOR
References: