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

Lactated Ringer's Versus 5% Human Albumin: A Double-Blinded, Randomized, Prospective Study in Cardiac Surgical Patients

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.

Study Overview

• Status: Terminated
• Conditions: Hemodynamic Stability
• Intervention / Treatment: Drug: Lactated Ringer's; Drug: 5% Human Albumin

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lactated Ringer's; Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.	Drug: Lactated Ringer's; Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.
Active Comparator: 5% Human Albumin; Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.	Drug: 5% Human Albumin; Colloid given for hemodynamic resuscitation based off of individual patient needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Fluid Administered Indexed to Weight	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.	Start of surgery up to 6 hours into the intensive care unit (ICU)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: William C. Oliver
• Investigators: Principal Investigator: William Oliver, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 9, 2017
• Study Completion (Actual): October 9, 2017

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 11, 2016
• First Posted (Estimate): January 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Lactated Ringer's; Human Albumin
• Other Study ID Numbers: 15-000858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No