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

Hemodynamic Stability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02654782
• Other study ID #: 15-000858
• Status: Terminated
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: October 9, 2017

Study information

• Verified date: March 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 9, 2017
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamic Stability

Intervention

Drug:
• Lactated Ringer's
Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.
• 5% Human Albumin
Colloid given for hemodynamic resuscitation based off of individual patient needs.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
William C. Oliver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials