Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline
- Conditions
- Acute Hypovolemia
- Interventions
- Other: Volume resuscitation (Crystalloid)Other: Volume resuscitation (Hypertonic Saline Solution)
- Registration Number
- NCT00683007
- Lead Sponsor
- University of California, Davis
- Brief Summary
The purpose of this study is to examine how the heart functions when a calculated amount of blood is removed and how two fluids, Lactated Ringer's (considered the standard replacement fluid) and Hypertonic Saline, re-expand the vascular system.
- Detailed Description
This investigator-initiated, single-center, prospective, randomized, clinical experimental design will enroll 30 patients scheduled for elective radical prostatectomy, cystectomy, or cystoprostatectomy, and anterior/posterior spinal fusions, which includes routine acute normovolemic hemodilution (ANH) as a technique to decrease the need for banked blood transfusions. The purpose of this study is to compare two methods of volume replacement during the ANH procedure. Patients will be randomized to receive either standard crystalloid replacement with Lactated Ringers (LR) or 5% hypertonic saline. Selected measurements will be obtained by transesophageal echocardiography (TEE) for assessing changes in left ventricular volume and function associated with blood loss and replacement. This study will use the Accuson Cypress Cardiovascular System and the V5M transesophageal echocardiography probe (Siemens Medical Solutions, Malvern, PA). The TEE measurements will be recorded on magnetic optical discs and assessed off-line by the researcher after the data collection is completed using the proprietary software included in the ultrasound system. In addition, stroke volume variation measurement (SVV), Cardiac Output (CO), Cardiac Index (CI), and Stroke Volume Index (SVI) will be measured using the Vigileo (TM) arterial pressure monitor with the FloTrac (TM) sensor (Edwards Lifesciences, Irvine, CA).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Elective surgical patients requiring acute normovolemic hemodilution
- Contraindication for hemodilution
- Contraindication for TE echo
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Volume resuscitation (Crystalloid) Crystalloid 2 Volume resuscitation (Hypertonic Saline Solution) Hypertonic Saline
- Primary Outcome Measures
Name Time Method TE echo LV 3-D volume changes. 1 hour
- Secondary Outcome Measures
Name Time Method APCO system changes. 1 hour
Trial Locations
- Locations (1)
University of California Davis Medical Center
🇺🇸Sacramento, California, United States