Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683007
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Hypovolemia Other: Volume resuscitation (Crystalloid) Other: Volume resuscitation (Hypertonic Saline Solution) Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Transesophageal Echocardiography to Assess Left Ventricular Performance During Acute Normovolemic Hemodilution and Randomized Replacement With Intravenous Crystalloid or Hypertonic Saline
Study Start Date : May 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Active Comparator: 1
Other: Volume resuscitation (Crystalloid)
Crystalloid vs. Hypertonic Saline Solution
Active Comparator: 2
Hypertonic Saline
Other: Volume resuscitation (Hypertonic Saline Solution)
Crystalloid vs. Hypertonic Saline Solution

Primary Outcome Measures :
  1. TE echo LV 3-D volume changes. [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. APCO system changes. [ Time Frame: 1 hour ]

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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective surgical patients requiring acute normovolemic hemodilution

Exclusion Criteria:

  • Contraindication for hemodilution
  • Contraindication for TE echo

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683007

United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95758
Sponsors and Collaborators
University of California, Davis
Study Director: Neal W. Fleming, M.D., Ph.D. Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
Principal Investigator: David D. Rose, PhD Chief, Certified Registered Nurse Anesthetist, UC Davis, Department of Anesthesiology and Pain Medicine

Responsible Party: University of California, Davis Identifier: NCT00683007     History of Changes
Other Study ID Numbers: 232664
200815960 ( Other Identifier: UC Davis Instructional Review Goard )
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
TE echo
Arterial Pressure Cardiac Output

Additional relevant MeSH terms:
Pathologic Processes
Pharmaceutical Solutions