Hemodynamic Stability
Conditions
Keywords
Lactated Ringer's, Human Albumin
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.
Interventions
Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.
DRUG5% Human Albumin
Colloid given for hemodynamic resuscitation based off of individual patient needs.
Sponsors
William C. Oliver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Fluid Administered Indexed to Weight | Start of surgery up to 6 hours into the intensive care unit (ICU) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alveolar-arterial Gradient | Calculated throughout the study up to 6 hours in the ICU | Alveolar-arterial gradient will be calculated from arterial blood gases on each patient. This value will be used to compare shunt in each arm. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at Mayo Clinic in Rochester, Minnesota.
Participants by arm
| Arm | Count |
|---|---|
| Lactated Ringer's Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.
Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs. | 5 |
| 5% Human Albumin Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.
5% Human Albumin: Colloid given for hemodynamic resuscitation based off of individual patient needs. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Lactated Ringer's | 5% Human Albumin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian, Indian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 5 Participants | 9 Participants |
| Region of Enrollment United States | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: Start of surgery up to 6 hours into the intensive care unit (ICU)
Population: 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.
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.
Time frame: Calculated throughout the study up to 6 hours in the ICU
Population: 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.