Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00683007

Purpose

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	Intervention	Phase
Acute Hypovolemia	Other: Volume resuscitation (Crystalloid) Other: Volume resuscitation (Hypertonic Saline Solution)	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Use of Transesophageal Echocardiography to Assess Left Ventricular Performance During Acute Normovolemic Hemodilution and Randomized Replacement With Intravenous Crystalloid or Hypertonic Saline

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

TE echo LV 3-D volume changes. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

APCO system changes. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Crystalloid	Other: Volume resuscitation (Crystalloid) Crystalloid vs. Hypertonic Saline Solution
2: Active Comparator Hypertonic Saline	Other: Volume resuscitation (Hypertonic Saline Solution) Crystalloid vs. Hypertonic Saline Solution

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).

Eligibility

Ages Eligible for Study:	17 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Elective surgical patients requiring acute normovolemic hemodilution

Exclusion Criteria:

Contraindication for hemodilution
Contraindication for TE echo

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683007

Contacts

Contact: Carolyn E. Murdock

916-734-5394

carolyn.murdock@ucdmc.ucdavis.edu

Locations

United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95758

Sponsors and Collaborators

University of California, Davis

Investigators

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

More Information

Publications:

Cheung AT, Savino JS, Weiss SJ, Aukburg SJ, Berlin JA. Echocardiographic and hemodynamic indexes of left ventricular preload in patients with normal and abnormal ventricular function. Anesthesiology. 1994 Aug;81(2):376-87.

Responsible Party:	UC Davis, Department of Anesthesiology and Pain Medicine ( Neal Fleming, MD, PhD )
Study ID Numbers:	200815960, 200815960-1
Study First Received:	May 8, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00683007 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

TE echo
hemodilution
hypertonic
saline
Arterial Pressure Cardiac Output

Study placed in the following topic categories:

Hypovolemia
Esophageal Disorder
Esophageal Diseases

Additional relevant MeSH terms:

Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on May 07, 2009