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

NCT02654782 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 15-000858
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Stability

Keywords

Lactated Ringer's; Human Albumin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Alveolar-arterial Gradient

  Calculated throughout the study up to 6 hours in the ICU

Study Arms (2)

Lactated Ringer's

ACTIVE COMPARATOR

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

Drug: Lactated Ringer's

5% Human Albumin

ACTIVE COMPARATOR

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

Drug: 5% Human Albumin

Interventions

Lactated Ringer's DRUG

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

Lactated Ringer's

5% Human Albumin DRUG

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

5% Human Albumin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant female patients
• Patients undergoing elective cardiac surgery
• Aspirin, heparin, or warfarin preoperatively accepted

You may not qualify if:

• 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

Sponsors & Collaborators

• William C. Oliver: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Ringer's Lactate; Serum Albumin, Human

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Limitations and Caveats

The study was terminated early. This was a student project and the student performing the study left Mayo Clinic and there were no funds to continue study. Targeted enrollment of 40 subjects was not met and data was not analyzed.

Results Point of Contact

• Title: Dr. William C. Oliver, Jr.
• Organization: Mayo Clinic

oliver.william@mayo.edu

507-255-4240

Study Officials

• William Oliver, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 13, 2016
• Study Start: January 1, 2016
• Primary Completion: October 9, 2017
• Study Completion: October 9, 2017
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)