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

NCT ID: NCT02654782

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-10-09

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.

Conditions

Hemodynamic Stability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lactated Ringer's

Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.

Group Type: ACTIVE_COMPARATOR

Lactated Ringer's

Intervention Type: DRUG

Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.

5% Human Albumin

Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.

Group Type: ACTIVE_COMPARATOR

5% Human Albumin

Intervention Type: DRUG

Colloid given for hemodynamic resuscitation based off of individual patient needs.

Interventions

Lactated Ringer's

Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.

Intervention Type: DRUG

5% Human Albumin

Colloid given for hemodynamic resuscitation based off of individual patient needs.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William C. Oliver

OTHER

Sponsor Role: lead

Responsible Party

William C. Oliver

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

William Oliver, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

15-000858

Identifier Type: -

Identifier Source: org_study_id