Lactated Ringer's Versus 5% Human Albumin: Cardiac Surgical Patients
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | January 2016 |
| End Date: | December 2016 |
Lactated Ringer's Versus 5% Human Albumin: A Double-Blinded, Randomized, Prospective Study in Cardiac Surgical Patients
Looking at individual total fluid volume and alveolar-arterial gradient with 5% human
albumin and Lactated Ringer's in the perioperative cardiac surgical patient.
Our hypothesis 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.
albumin and Lactated Ringer's in the perioperative cardiac surgical patient.
Our hypothesis 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.
Following 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. Outcome measures of hemodynamic instability will include systolic and diastolic
blood pressures; mean arterial pressure, central venous pressure, cardiac index, urine
output, and vasopressor use. Alveolar-arterial gradient will be assessed between the two
choices of fluid to determine any relationship with fluid choice and duration of intubation
in the intensive care unit. Blinding of the fluid therapy has not been done in this group of
patients so detection of bias towards one of the fluids may be appreciated.
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. Outcome measures of hemodynamic instability will include systolic and diastolic
blood pressures; mean arterial pressure, central venous pressure, cardiac index, urine
output, and vasopressor use. Alveolar-arterial gradient will be assessed between the two
choices of fluid to determine any relationship with fluid choice and duration of intubation
in the intensive care unit. Blinding of the fluid therapy has not been done in this group of
patients so detection of bias towards one of the fluids may be appreciated.
Inclusion Criteria:
Adult male Non-pregnant female patients Elective cardiac surgery Aspirin, heparin, or
warfarin preoperatively are accepted
Exclusionary Criteria:
Previous sternotomy Emergency surgery Combined procedures involving vascular or thoracic
operations Congenital heart repair Hypothermic CPB < 28C Serum creatinine 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 FEV1 < 45% of predicted Home
oxygen use Previous difficult intubation Acute normovolemic blood conservation techniques
Primary liver disease with serum AST > 31 U/L Circulatory arrest Thrombolysis Pre-existing
clotting disorder Platelet receptor GPIIb/IIIa antagonists medication received within 48
hours Steroids Left ventricular 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.
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